Duke Cancer Protocol Fast Facts
Duke Comprehensive Cancer Cancer
Clinical Trials at Duke Comprehensive Cancer Center
November 7, 2009
| BMT and Cellular Therapies | |||||||
| Sponsor | Sponsor ID | Protocol | Phase | Eligibility | Contact | IRB# | |
| Duke | Myeloablative Allogeneic Stem Cell Transplantation using a Naive T-cell Depleted Peripheral Blood Stem Cell Graft | I/II | 919- 668-6728 | 00000993 | |||
| NMDP | A Phase II Multicenter Trial of Myeloablative Double Unit Umbilical Cord Blood Transplantation (UCBT) in Adults with Hematologic Malignancy | II | 919- 668-6728 | 00001789 | |||
| OTHER | CT-2007-01 | Phase II Safety and Efficacy Study of the Monoclonal Antibody CT-011 in Patients with Diffuse Large B-Cell Lymphoma following Autologous Stem Cell Transplantation | II | 919- 668-6728 | 00001809 | ||
| Duke | 05075 | Safety Trial of NK Cell DLIs from 3-5/6 HLA Matched Family Member Following Nonmyeloablative Allogeneic SCT | Pilot/Feasibility | <= grade 2 acute GvHD | 919- 668-6728 | 00005123 | |
| Duke-NCI | 02139 | Allogeneic Non-Myeloablative Stem Cell Transplantation Utilizing Mismatched Siblings Stem Cells Purged Using Campath-1H. | II | Dx-dependent | 919- 668-6728 | 00009528 | |
| Duke | Genetic Studies of Bipolar Disorder and Related Traits | N/A | 919- 668-6728 | ||||
| Duke | 07127 | A Phase I Study of Cancer Peptides Plus GM-CSF and Adjuvant (Montanide ISA 51) Following Completion of Prescribed Chemotherapy or Trastuzumab for TXN2-3M0 or Metastatic Breast Cancer with no Evidence of Disease | I | NED post adj CT or Herceptin | 919- 668-6728 | 00000902 | |
| Duke-NCI | 04077 | A Phase I, Open-Label, Dose-Escalation, Multidose Study of CDX-1307, A Mannose Receptor-Targeted hcG-B Vaccine, in Patients with Locally Advanced or Metastatic Breast, Colorectal, Pancreatic, Bladder or Ovarian Cancer | I | <=2 prior CTs | 919- 668-6728 | 00007703 | |
| Duke-NCI | 04030 | Pilot Study of Interferon Alfa for Patients Who Have Received Cancer Vaccines | Pilot/Feasibility | 1-4 wks post DCs | 919- 668-6728 | 00014489 | |
| Duke | 99101 | Allogeneic Mixed Chimerism Stem Cell Transplantation Utilizing In Vivo & In Vitro Campath-1H for Hemoglobinopathies and Bone Marrow Failure Syndromes. | II | Treated | 919- 668-6728 | 00008771 | |
| Duke-NCI | 02118 | Allogeneic Non-Myeloablative Stem Cell Transplantation Utilizing Matched Family Member Stem Cells Purged Using CAMPATH-1H. | II | Treated | 919- 668-6728 | 00008380 | |
| Duke-NCI | 07142 | A Phase I Study of WT1 Peptides to Induce Anti-Leukemia Immune Responses Following Autologous or Allogeneic Transplantation for AML, CML, ALL, MDS and WT1 Expressing B Cell Malignancies | I | WT1 positive | 919- 668-6728 | 00001360 | |
| Duke | 07167 | A Phase II Study of Intrathecal Therapy with DepoCYT for Active Lymphomatous or Leukemia Meningitis | II | 919- 668-6728 | 00009742 | ||
| Brain Cancer | |||||||
| Duke | 07215 | Phase I Study of Zactima (ZD6474) Plus Imatinib Mesylate and Hydroxyurea for Patients with Recurrent Malignant Glioma | I | 1st, 2nd or 3rd recurrence or relapse | 919- 668-6728 | 00000393 | |
| Merck | A Phase I Study of MK-0752 in Pediatric Patients with Recurrent or Refractory CNS Malignancies | I | 919- 668-6728 | 00014101 | |||
| Exelixis, Inc. | A Phase II Study of XL184 in Subject with Progressive or Recurrent Glioblastoma Multiforme in First or Second Relapse | II | 919- 668-6728 | 00016989 | |||
| A Phase II Study of TLN-4601 in Patients with Glioblastoma Multiforme (TLN-4601-201) | II | 919- 668-6728 | 00013436 | ||||
| Duke | Phase II Single-Arm Study of Pre-Operative Stereotactic Radiosurgery for Brain Metastases | II | 919- 668-6728 | 00006870 | |||
| Duke | 06074 | Pilot Study of Dronabinol for Adult Patients with Primary Gliomas | I | 919- 668-6728 | 00007559 | ||
| Novacea | 07126 | A Phase II, Multicenter, Open-Label Case-Controlled (Part 1), Randomized, Active-controlled (Part 2) Study of AQ4N, in Combination with Radiotherapy and Temozolomide, for Safety, Tolerability and Activity in Subjects with newly Diagnosed Glioblastoma Mult | II | No prior RT or CT | 919- 668-6728 | 00000305 | |
| Duke-NCI | 06042 | ATTAC: Anti-Tumor Immunotherapy Targeted Against Cytomegalovirus in Patients with Newly Diagnosed Glioblastoma Multiforme During Recovery from Therapeutic Temozolomide-Induced Lymphopenia | N/A | <6 weeks prior resection | 919- 668-6728 | 00003877 | |
| Duke | 07112 | REGULATory T-Cell Inhibition with Daclizumab (Zenapaxr) during Recovery from Therapeutic Temozolomide-induced Lymphopenia during Antitumor Immunotherapy Targeted against Cytomegalovirus in Patients with Newly-Diagnosed Glioblastoma Multiforme | I | New diagnosis | 919- 668-6728 | 00000581 | |
| Genen | 4876646 | A Phase II, Multicenter, Randomized, Non-Comparative Clinical Trial to Evaluate the Efficacy and Safety of Bevacizumab Alone or In Combination with Irinotecan for Treatment of Glioblastoma Multiforme in First or Second Relapse | II | 1st & 2nd relapse must have received temozolomide | 919- 668-6728 | 00008082 | |
| Amgen | A Multicenter, Open-Label, Single Agent, Two-Stage Phase II Study to Evaluate the Efficacy and Safety of AMG 102 in Subjects with Advanced Malignant Gliomas | II | <=3 prior relapses | 919- 668-6728 | 00000279 | ||
| Duke | 07138 | Avastin in Combination with Metronomic Temozolomide for Recurrent Malignant Glioma | II | Allows prior failure 5-d TMZ | 919- 668-6728 | 00000404 | |
| Duke-GENENTECH | 07080 | Phase II Trial of Erlotinib plus Sirolimus for Patients with Recurrent Malignant Gliobastoma Multiforme | II | No prior anti-MTOR or EGFR RX | 919- 668-6728 | 00000345 | |
| EntreMed | 06030 | A Single-Center, Open-Label, Phase II, Safety, Pharmacokinetic and Efficacy Study of Panzem Nanocrystal Colloidal Dispersion Administered Orally to Patients with Recurrent Glioblastoma Multiforme | II | 4 wk CT window | 919- 668-6728 | 00012498 | |
| NABTC | NABTC 04-01 | A Biomarker and Phase II Study of GW572016 in Recurrent Malignant Glioma | II | <= 3 recurrences | 919- 668-6728 | 00011613 | |
| Duke-GENENTECH | 07017 | Open-label Phase II Trial of Bevacizumab Plus Erlotinib for Patients with Recurrent Malignant Glioma | II | Recurrent disease | 919- 668-6728 | 00000220 | |
| NOVARTIS | 06055 | A phase II, open-label, multi-centre, single-arm study, evaluating the efficacy of Glivec plus Hydroxyurea in patients with progressive glioblastoma multiforme (GBM), not receiving enzyme inducing anticonvulsant drugs (EIACDs) | II | Not on EIACDs | 919- 668-6728 | 00004901 | |
| NOVARTIS | 06056 | A phase II, open-label, multi-centre, single-arm study, evaluating the efficacy of Glivec plus Hydroxyurea in patients with progressive glioblastoma multiforme (GBM), receiving enzyme inducing anticonvulsant drugs (EIACDs) CST157H2202 | II | Receiving EIACDs | 919- 668-6728 | 00004710 | |
| Duke | 07217 | Phase II Study of Sorafenib plus Protracted Temozolomide in Recurrent Glioblastoma Multiforme | II | 1st, 2nd, or 3rd relapse. Need prior XRT | 919- 668-6728 | 00000464 | |
| Duke | BUS221 | A Phase II Study of Imatinib Mesylate Plus Hydroxyurea in the Treatment of Patients with Recurrent/Progressive Meningioma | II | Recurrent or progressive | 919- 668-6728 | 00006768 | |
| Breast Cancer | |||||||
| Genen | Adjuvant paclitaxel and trastuzumab for node-negative HER2-positive breast cancer | II | 919- 668-6728 | 00007235 | |||
| Hoffmann | A Randomized, Multicenter, Phase III Open-Label Study Of The Efficacy And Safety Of Trastuzumab-Mcc-Dm1 Vs. Capecitabine + Lapatinib In Patients With Her2-Positive Locally Advanced Or Metastatic Breast Cancer Who Have Received Prior Trastuzumab-Based | III | 919- 668-6728 | 00015169 | |||
| CALGB | 60202 | CALGB 60202 A Correlate to CALGB 40101 | III | 919- 668-6728 | 00009899 | ||
| CALGB | 40101 | CALGB 40101: Cyclophosphamide and Doxorubicin (CA x 4 cycles) versus Paclitaxel (4 cycles) as Adjuvant Therapy for Women with Node-Negative Breast Cancer: A 2x2 Factorial Phase III Randomized Study. | III | ADJ | 919- 668-6728 | 00009899 | |
| Duke-NCI | 03019 | Pharmacogenomics Study for Breast Cancer Patients Undergoing Adjuvant Chemotherapy with Doxorubicin (A)/ Cyclophosphamide (C) and/or Weekly Paclitaxel (P). | N/A | ADJ | 919- 668-6728 | 00014267 | |
| ACOS | ACOSOG Z1031 | A Randomized Phase III Trial Comparing 16 to 18 Weeks of Neoadjuvant Exemestane (25mg daily), Letrozole (2.5mg), or Anastrozole (1mg) in Postmenopausal Women with Clinical Stage II and III Estrogen Receptor Positive Breast Cancer | III | ER+, post-men | 919- 668-6728 | 00006996 | |
| OTHER | 06068 | A Phase I, Dose Escalation and Pharmacokinetics Study of Temperature Sensitive Liposome Encapsulated-Doxorubicin (ThermoDox) and Hyperthermia in Patients with Local-Regionally Recurrent Breast Cancer | I | Recurrent | 919- 668-6728 | 00014340 | |
| Duke | 06065 | A Phase Ib Study With Biologic Endpoints Of Paclitaxel and 2-Methoxyestradiol (Panzem Nanocrystal Colloidal Dispersion) In Metastatic Breast Cancer | I | No prior weekly Taxol | 919- 668-6728 | 00014271 | |
| Bionovo, Inc. | 07086 | A Phase I/II Clinical Trial Assessing the Safety and Efficacy of BZL 101 for Metastatic Breast Cancer | I/II | <=2 prior CT; any # hormones | 919- 668-6728 | 00014988 | |
| Genen | AVF3693g | A Phase III, Multicenter, Randomized, Placebo-Controlled Trial Evaluating The Efficacy And Safety Of Bevacizumab In Combination With Chemotherapy Regimens In Subjects With Previously Treated Metastatic Breast Cancer | III | Treated | 919- 668-6728 | 9260 | |
| OTHER | 07103 | A Phase II Study of Abraxane, Carboplatin and Bevacizumab in Triple Negative (Demonstrating no Expression for Estrogen, Progesterone, or HER2 Receptors) Metastatic Breast Cancer | II | No prior study drugs or taxanes | 919- 668-6728 | 00014837 | |
| GSK | EGF10027 | Phase I, Open-Label Study of the Safety, Pharmacokinetics and Pharmacodynamics of GW572016 in Once Daily Vs. Twice Daily Dosing Regimens in Patients with Treatment-Naive Breast Cancer | I | >=2cmtumor; untreated | 919- 668-6728 | 5518 | |
| GW | EGF103009 | Phase II Study to Evaluate the Efficacy, Safety and Pharmacodynamics of Lapatinib in Patients with Relapsed or Refractory Inflammatory Breast Cancer. | II | ErbB1/2+ | 919- 668-6728 | 00010021 | |
| OTHER | 07090 | A Phase II Safety and Tolerability Study of Bevacizumab when Added to Single Agent Chemotherapy to Treat Patients with Breast Cancer Metastatic to the Brain | II | Any # prior CTs out 2 wks | 919- 668-6728 | 00014926 | |
| Reata Pharmaceuticals, Inc. | A Phase II Efficacy and Tolerability Study of RTA744 in Breast Cancer Patients with Progression of Previously Irradiated Brain Metastasis | II | Progressed after whole brain irradiation | 919- 668-6728 | 00002106 | ||
| Duke Cancer Care Research Program | |||||||
| Pfizer | A Pilot Study to Evaluate the Feasibility and Potential Efficacy of the Pathfinders Program for Metastatic Breast Cancer Patients | Pilot/Feasibility | 919- 668-6728 | 00012996 | |||
| Duke | 07169 | Longitudinal Evaluation of Management Strategies and Their Impact in Metastatic Colon Cancer: Retrospective Chart Review | N/A | 919- 668-6728 | 00008681 | ||
| Gastrointestinal Cancers - Colorectal cancers and cancers of the stomach, esophagus and other digestive organs | |||||||
| Duke-GENENTECH | 07108 | A Phase II Study of Oxaliplatin, Capecitabine and Bevacizumab in the Treatment of Metastatic Esophagogastric Adenocarciomas | II | 919- 668-6728 | 00008710 | ||
| NOVARTIS | A Multicenter, Randomized, Blinded Efficacy and Safety Study of Pasireotide LAR vs Octreotide LAR in Patients with Metastatic Carcinoid Tumors Whose Disease-related Symptoms are Inadequately Controlled by Somatostatin Analogues | II | 919- 668-6728 | 00007293 | |||
| Bristol | CA182006 | A Phase II Open Label Study of Brivanib (BMS-582664), Administered Orally At A Dose of 800 mg Daily in Subjects with Unresectable, Locally Advanced or Metastatic Hepatocellular Carcinoma Who Have Received Either No Prior Systemic Therapy or One Prior Regi | II | 919- 668-6728 | 00008012 | ||
| Amgen | A Phase 1b/2 Study to Evaluate the Safety and Efficacy of AMG 655 or AMG 479 in Combination with Gemcitabine as First-Line Therapy for Metastatic Pancreatic Cancer | I/II | 919- 668-6728 | 00007054 | |||
| NOVARTIS | CRAD001C2325 | A Randomized, Double Blind, Placebo-Controlled, Multicenter Phase III Study in Patients with Advanced Carcinoid Tumor Receiving Sandostatin LAR and RAD001 10 mg/d or Sandostatin LAR and placebo | III | 919- 668-6728 | 00001497 | ||
| Duke-GENENTECH | AVF3116s | A Phase I/II Trial of Radiation, Avastin and Tarceva for Resectable or Locally Advanced Pancreatic Adenocarcinoma | I/II | 919- 668-6728 | 00001597 | ||
| Genen | AP03583g | A Phase 1b, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of Multiple Doses of Apo2L/TRAIL Administered Intravenously in Combination with Camptosar/Erbitux Chemotherapy in Subjects with Previously Treated Metastatic Colorectal Cance | I | 919- 668-6728 | 00013018 | ||
| BMS-354825 | A Phase I Study of Capecitabine, Oxaliplatin, Bevacizumab, and Dasatinib for Patients with Advanced Solid Tumors with Expanded Cohort of Patients with Previously Untreated Metastatic Colorectal Cancer. | I/II | 919- 668-6728 | 00010354 | |||
| NOVARTIS | A Phase I Open Label/ Phase II Randomized, Double-Blind, Multicenter Study Investigating the Combination of RAD001 and Sorafenib (Nexavar) in Patients With Locally Advanced Hepatocellular Carcinoma | I/II | 919- 668-6728 | 00010959 | |||
| EFC6521 | A Multinational, Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AVE5026 in the Prevention of Venous Thromboembolism (VTE) in Cancer Patients at High Risk for VTE and Who are Undergoing Chemotherapy | III | 919- 668-6728 | 00011744 | |||
| Schering | 56,592 | A Phase IV Study of the Pharmacokinetics of Oral Posaconazole (SCH 56592) Among Patients with Compromised Gastrointestinal Function and at High Risk for Invasive Fungal Infection | IV | 919- 668-6728 | 00003414 | ||
| CTSU | 5202 | CTSU ECOG 5202 A Randomized Phase III Study Comparing 5-FU, Leucovorin and Oxaliplatin versus 5-FU, Leucovorin, Oxaliplatin and Bevacizumab in Patients with Stage II Colon Cancer at High Risk for Recurrence to Determine Prospectively the Prognostic Value | III | 919- 668-6728 | 00005437 | ||
| Pfizer | A Treatment Protocol for Patients Continuing from a Prior SU011248 Protocol | IV | 919- 668-6728 | 00009042 | |||
| Bristol | 07114 | A Phase I Study of the Combinations of Gemcitabine plus Dasatinib or Gemcitabine, Cetuximab, and Dasatinib in Patients with Refractory Solid Tumors with Expansion to the First-Line Treatment of Advanced Pancreatic Cancer | I | Refractory disease | 919- 668-6728 | 00012976 | |
| Genitourinary Cancers - Prostate cancer and cancers of the kidney, bladder, and male organs | |||||||
| Pfizer | A Multicenter, Randomized, Double-Blind, Phase III Study of Sunitinib Plus Prednisone versus Prednisone in Patients with Progressive Metastatic Hormone-Refractory Prostate Cancer After Failure of a Docetaxel-Based Chemotherapy Regimen | III | 919- 668-6728 | 00011630 | |||
| Pfizer | Multimodality Therapy for Recurrent High Risk Prostate Cancer: A Phase II Study | II | 919- 668-6728 | 00010747 | |||
| Trofex TX-P101 | A Phase I Study Evaluating the Safety, Pharmacokinetics, Tissue Distribution, Metabolism of Small Molecule Inhibitors of Prostate Specific Membrane Antigen: Determination of I-123 Radiation Dosimetry for I-123-MIP-1072 and I-123-MIP-1095 | I | 919- 668-6728 | 00003552 | |||
| OTHER | 07TASQ08 | Phase II Randomized Double Blind Placebo-controlled Study to Determine the Efficacy of ABR-215050 in Asymptomatic Patients with Metastatic Castrate-Resistant Prostate Cancer - 07TASQ08 | II | 919- 668-6728 | 00003687 | ||
| A Phase III, Randomized, Double-blind, Placebo-Controlled Study of Abiraterone Acetate (CB7630) Plus Prednisone in Asymptomatic Patients with Metastatic Castration-Resistant Prostate Cancer (Cougar 302) | III | 919- 668-6728 | 00016752 | ||||
| RTOG | RTOG 0712 | A Phase II Randomized Study For Patients With Muscle-Invasive Bladder Cancer Evaluating Transurethral Surgery And Concomitant Chemoradiation By Either BID Irradiation Plus 5-Fluorouracil And Cisplatin Or QD Irradiation Plus Gemcitabine Followed By Select | II | 919- 668-6728 | 00014357 | ||
| RTOG | RTOG - 0841 | Radiation Therapy Oncology Group RTOG 0841 Efficiency Of Screening For Depression In Cancer Patients Receiving Radiotherapy | N/A | 919- 668-6728 | 00017905 | ||
| OTHER | XRP6976J/3503 | A Randomized, Open Label, Multicenter, Phase III, 2-Arm Study of Androgen Deprivation with Leuprolide, +/- Docetaxel for Clinically Asymptomatic Prostate Cancer Subjects with a Rising PSA Following Definitive Local Therapy XRP6976J/3503 / III | III | 919- 668-6728 | 00007163 | ||
| Wyeth-Ayerst | Phase 3b, Randomized, Open-Label Study of Bevacizumab (Avastin®) + Temsirolimus (Torisel®) vs. Bevacizumab (Avastin®) + Interferon-Alfa (Roferon®) as First-Line Treatment in Subjects With Advanced Renal Cell Carcinoma | III | 919- 668-6728 | 00007416 | |||
| Bristol | CA180086 | Phase I/II Study of Dasatinib and Docetaxel in Metastatic Hormone Refractory Prostate Cancer (CA180086) | I/II | 919- 668-6728 | 00007777 | ||
| Wilex WX/20-001 | A Comparative Study of PET/CT versus Diagnostic CT for the Detection of Clear Cell Renal Cell Carcinoma in Pre-surgical Patients with Renal Masses Using Iodine-124 labeled Chimeric G250 (124I-cG250) | III | 919- 668-6728 | 00007872 | |||
| ImClone | CP18-0601: A Phase 2, Multicenter, Randomized Study of IMC A12 or IMC 1121B Plus Mitoxantrone and Prednisone in Metastatic Androgen-Independent Prostate Cancer (AIPC) Following Disease Progression on Docetaxel-Based Chemotherapy | II | 919- 668-6728 | 00007984 | |||
| Duke | Impact of Noise Canceling Headphones on Pain Perception and Anxiety Associated with Prostate Needle Biopsy | Pilot/Feasibility | 919- 668-6728 | 00001593 | |||
| Dendreon Corporation | PB01 | An Open Label, Single Arm Trial of Immunotherapy with Autologous Antigen Presenting Cells Loaded with PA2024 (APC8015F) for Men with Objective Disease Progression on Protocol D9902 Part B | II | 919- 668-6728 | 00000310 | ||
| Duke | 07159 | A Phase I Dose Escalation Study of Cryotherapy Followed by Radiation Therapy in Patients with Intermediate Risk, Clinically Localized Carcinoma of the Prostate | I | No prior RX | 919- 668-6728 | 00012130 | |
| Duke | 05058 | Phase I Dose-Escalation Study of Preoperative RT Followed by Radical Prostatectomy in Patients with High-Risk, Localized Carcinoma of the Prostate. | I | High risk | 919- 668-6728 | 00006510 | |
| Dana-Farber Cancer Institute | 07133 | A Phase II Study of Neoadjuvant Bevacizumab plus Docetaxel in High Risk Patients with Prostate Cancer undergoing Radical Prostatectomy | II | NO prior RX, PSA>=20 | 919- 668-6728 | 00000181 | |
| OTHER | XRP6976J/3501 | XRP6976J/3501 A Multicenter, Open-Label, Randomized, Phase III Trial Comparing Immediate Adjuvant Hormonal Therapy (ELIGARD -leuprolide acetate) in Combination with Taxotere (docetaxel) Administered Every Three Weeks Versus Hormonal Therapy Alone Versus D | III | No prior CT/RT | 919- 668-6728 | 00000100 | |
| RTOG | 0415 | RTOG 0415: A Phase II Randomized Study of Hypofractionated 3D-CRT/IMRT Versus Conventionally Fractionated 3D-CRT/IMRT in Patients with Favorable-Risk Prostate Cancer | II | No prior RX | 919- 668-6728 | 00008931 | |
| Duke | 05138 | A Single Arm, Phase II Study of RAD001 in Patients with Metastatic, Hormone-Refractory Prostate Cancer | II | 4 wk prior therapy window | 919- 668-6728 | 00009495 | |
| Dendreon Corporation | D9902 | A Randomized, Double-Blind, Placebo-Controlled, Phase II Trial of Immunotherapy with Autologous Antigen Presenting Cells Loaded with PA2024 (Provenge, APC8015) in Men with Metastatic Androgen Independent Prostatic Adenocarcinoma | III | PSA>=5.0 | 919- 668-6728 | 00000309 | |
| Duke | 07036 | Prospective Validation of a Microarray-Based Docetaxel Response Signature in Metastatic, Hormone-Refractory Prostate Cancer | N/A | No prior docetaxel/Taxol | 919- 668-6728 | 00011890 | |
| Pfizer | 07078 | A Phase I/II Safety and Pharmacokinetic Study of SU011248 in Combination with Docetaxel (Taxotere) and Prednisone in Patients with Metastatic Hormone Refractory Prostate Cancer (HRPC) | I/II | No prior CT | 919- 668-6728 | 00008991 | |
| CALGB | 90202 | CALGB 90202: Randomized Double-Blind, Placebo-Controlled Phase III Study of Early vs Standard Zoledronic Acid to Prevent Skeletal Related Events in Men with Prostate Cancer Metastatic to Bone. | III | No prior bisphosphonates | 919- 668-6728 | 00009388 | |
| NOVARTIS | 07218 | A Single Arm, Phase IB Study of RAD001 and Sunitinib in Patients with Advanced Renal Cell Carcinoma | I | Clinical or radiographic evidence of mets | 919- 668-6728 | 00000548 | |
| NOVARTIS | 07164 | A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase III Study to Compare the Safety and Efficacy of RAD001 Plus Best Supportive Care (BSC) Versus BSC Plus Placebo in Patients with Metastatic Carcinoma of the Kidney which has Progressed on VE | III | 919- 668-6728 | 00000847 | ||
| Viventia Biotech, Inc | 07206 | Phase II Study to Evaluate the Efficacy and Tolerability of Intravesical Vicinium in Patients with Non-Invasive Urothelial Carcinoma In Situ (CIS) Previously Treated with Bacille Calmette-Guérin (BCG) VB4-845-02-IIA | II | Failed previous BCG | 919- 668-6728 | 00001275 | |
| Gynecological Cancers - Ovarian cancer and cancers of the female organs | |||||||
| Duke-GENENTECH | A Phase II Trial of Avastin in Combination with Docetaxel in Patients with Recurrence of Epithelial Carcinoma of the Ovary/Fallopian Tube/Peritoneum within 12 Months of Platinum Therapy | II | 919- 668-6728 | 00004900 | |||
| GOG | A Phase III Randomized Controlled Clinical Trial of Carboplatin and Paclitaxel Alone or in Combination with Bevacizumab (NSC #704865, IND #7921) Followed by Bevacizumab and Secondary Cytoreductive Surgery In Platinum-Sensitive, Recurrent Ovarian, Periton | III | 919- 668-6728 | 00007487 | |||
| GOG | GOG-0229I: A Phase II Evaluation of Brivanib (BMS582664, IND #105029), An Oral, Multitargeted Growth Factor Tyrosine Kinase Inhibitor in the Treatment of Recurrent or Persistent Endometrial Carcinoma (BMS Study CA182-029) | II | 919- 668-6728 | 00019289 | |||
| GOG | GOG-0232C | GOG 0232C: A Phase II Evaluation of Paclitaxel (TAXOL®, NSC #673089), Carboplatin (PARAPLATIN®, NSC #241240), and BSI-201 (NSC #746045, IND #71,677) in the Treatment of Advanced, Persistent, or Recurrent Uterine Carcinosarcoma | II | 919- 668-6728 | 00015753 | ||
| Duke | 07152 | A Phase I Trial of a SRC Kinase Inhibitor, Dasatinib in Combination with Paclitaxel and Carboplatin in Patients with Advanced or Recurrent Ovarian, Peritoneal, and Tubal Cancer BMS#CA180-081 | I | <= 3 prior CTs | 919- 668-6728 | 00012282 | |
| Eli Lily & Co. | B9E-US-S302(D) | Phase III Randomized Trial of Induction CT with Gemcitabine and Carboplatin Followed by Elective Paclitaxel Consolidation Vs. Paclitaxel and Carboplatin Followed by Elective Paclitaxel Consolidation in Patients with Primary Epithelial Ovarian, Primary Pe | III | No prior CT | 919- 668-6728 | 00010590 | |
| Sanofi-Synthelabo | PML0239 | A Pilot Phase II Study Evaluating the Combination of Oxaliplatin and Docetaxel with Bevacizumab as First Line Therapy in Patients with FIGO Stage IB-IV Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Carcinoma | II | First line | 919- 668-6728 | 00006461 | |
| Menarini Ricerche S.p.A | 07130 | A Randomized, Double-Blind, Placebo Controlled, Multicenter Trial of Abagovomab Maintenance Therapy in Patients with Epithelial Ovarian Cancer After Complete Response to First Line Chemotherapy | II | DDP-based CT | 919- 668-6728 | 00013704 | |
| GOG | GOG 0212 | GOG 0212 Randomized Phase III Trial of Maintenance Chemotherapy Comparing 12, Monthly Cycles of Single Agent Paclitaxel or Xyotax (CT-2103) (IND#70177), Versus No GOG 0212 Treatment Until Documented Relapse in Women with Advanced Ovarian or Primary Perito | III | CR on 1st line DDP/Taxane CT | 919- 668-6728 | 00006358 | |
| GOG | 0218 | GOG 0218 Phase III Trial of Carboplatin and Paclitaxel Plus Placebo Versus Carboplatin and Paclitaxel Plus Concurrent Bevacizumab (NSC #704865, IND #7921) followed by Placebo, Versus Carboplatin and Paclitaxel Plus Concurrent and extended Bevacizumab, in | III | No prior CT/RT | 919- 668-6728 | 00011660 | |
| Duke | 07083 | A Phase I Study of Ovarian Cancer Peptides Plus GM-CSF and Adjuvant (Montanide ISA 51) as Consolidation Following Debulking (Optimal or Suboptimal) and Systemic Chemotherapy for Women with Advanced Stage Ovarian, Tubal, or Peritoneal Cancer | I | CR to platin/taxane CT | 919- 668-6728 | 00013247 | |
| GOG | 187 | GOG 187: Phase II Study of Paclitaxel for Ovarian Stromal Tumors as First-Line or Second-Line Therapy. | II | 1st or 2nd line | 919- 668-6728 | 00005403 | |
| GOG | 0219 | GOG-0219: Phase III Randomized Trial of Weekly Cisplatin and Radiation Versus Cisplatin and Tirapazamine and Radiation in Stage 1B2, IIA, IIB, IIIB and IVA Cervical Carcinoma Limited to the Pelvis | III | Stages IB2, IIA, IIB, IIIB, IVA | 919- 668-6728 | 00006275 | |
| GOG | 209 | GOG 209: Randomized Phase III Trial of Doxorubicin/Cisplatin/Paclitaxel/G-CSF VS Carboplatin/Paclitaxel in Patients with Stage III and IV or Recurrent Endometrial Cancer. | III | No prior CT | 919- 668-6728 | 00008478 | |
| GOG | 0103 | GOG 130E A Phase II Evaluation of Gemcitabine (NSC #613327) and Docetaxel ( NSC #628503) in the Treatment of Recurrent or Persistent Carinosarcoma of the Uterus | II | 1 prior CT | 919- 668-6728 | 00006425 | |
| GOG | 205 | GOG 205: Phase II Trial of RT and Weekly Cisplatin CT for the Treatment of Locally-Advanced Squamous Cell Carcinoma of the Vulva. | II | Untreated | 919- 668-6728 | 00013409 | |
| Head and Neck Cancers- Cancers of the larynx, mouth, and throat area | |||||||
| C-0080-07 | Caphosol® for the Reduction of Mucositis in Patients Receiving Radiation Therapy for Head and Neck Cancer | IV | 919- 668-6728 | 00012816 | |||
| Sorafenib and Cetuximab in Recurrent and /or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) a Phase IB/II Trial | I/II | 919- 668-6728 | 00001516 | ||||
| Leukemia and multiple myeloma | |||||||
| CALGB | 20302 | CALGB 20302 A Correlate to CALGB 100101 | II | 919- 668-6728 | 00009118 | ||
| CALGB | 60303 | CALGB 60303 A Correlate to CALGB 10105 | II | 919- 668-6728 | 00006016 | ||
| CALGB | 60403 | CALGB 60403 A Correlate to CALGB 10105 | II | 919- 668-6728 | 00006016 | ||
| Genzyme Corporation | CLO34100405 | CLO34100405: A Phase III Randomized, Double-Blind, Controlled Study Comparing Clofarabine and Cytarabine versus Cytarabine Alone in Adult Subjects 55 Years and Older with Acute Myelogenous Leukemia (AML) who have Relapsed or are Refractory after Receiv | III | <=2 prior inductions | 919- 668-6728 | 00007306 | |
| Duke | 07013 | Phase I/II Study of Arsenic Trioxide (Trisenoxr). Ascorbic Acid and Bortezomib (Velcade r) Combination Therapy in Patients with Relapsed/Refractory Multiple Myeloma | I/II | No prior Trisenox | 919- 668-6728 | 00008662 | |
| Duke | 06035 | Phase I Study of Umbilical Cord Blood Transplantation Followed by Third Party Thymus Transplantation | I | No UCB identical or 5/6 donor | 919- 668-6728 | 00007995 | |
| Duke | 07026 | Phase II Trial of Sorafenib in Patients with Myelodysplastic Syndrome | II | No prior alloSCT | 919- 668-6728 | 00008151 | |
| Duke | 07035 | A Pilot Phase II Study of Decitabine, Arsenic Trioxide and Asorbic Acid for Patients with Myelodysplastic Syndrome | II | 4 wk prior therapy window | 919- 668-6728 | 00011792 | |
| Lung Cancer | |||||||
| Duke | Phase I Dose Escalation Study of Accelerated Fractionation With Esophageal Sparing Using Intensity-Modulated Radiation Therapy for Locally-Advanced Thoracic Malignancies Including a Prospective Assessment of Esophageal Motion and Radiation-Induced Esopha | I | 919- 668-6728 | 00017361 | |||
| CALGB | CALGB 30607: Randomized, Phase III, Double-Blind Placebo-Controlled Trial of Sunitinib (NSC #736511, IND #74019) as Maintenance Therapy in Non-Progressing Patients following an Initial Four Cycles of Platinum-Based Combination Chemotherapy in Advanced, | III | 919- 668-6728 | 00014547 | |||
| Bristol | Phase II Study of Dasatinib in Previously Treated Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) | II | 919- 668-6728 | 00008303 | |||
| CALGB | CALGB 150504 | CALGB 150504 Required Companion Substudy to CALGB 30406 | II | 919- 668-6728 | 00013056 | ||
| Duke | 06069 | Dose-Dense Induction/Neoadjuvant Chemotherapy in the Treatment of Patients with Locally-Advanced Non-small cell Lung Cancer with Additional Genomic Analyses to Identify Signatures Predicitive of Chemotherapy Response | II | No prior CT | 919- 668-6728 | 00004682 | |
| Duke | 07093 | Phase II Prospective Study Evaluating the Role of Pemetrexed Plus Gemcitabine Chemotherapy for Chemo-Naive Select Stage IIIB and IV Non-Small Cell Lung Cancer (NSCLC) in Patients Using a Genomic Predictor of Platinum Resistance to Guide Therapy | II | No prior CT | 919- 668-6728 | 00004599 | |
| CALGB | 30406 | CALGB 30406 A Phase II Randomized Study of OSI-774 (Erlotinib) with or without Carboplatin/Paclitaxel in Patients with Previously Untreated Adenocarcinoma of the Lung Who Never Smoked or Were Former Light Smokers | II | No prior CT | 919- 668-6728 | 00013056 | |
| Pfizer | A5301005 | Phase II Randomized Study of CP-868,596 in Combination with Docetaxel and of Docetaxel Alone in Patients with Stage IIIB of IV Non-Small Cell Lung Cancer, Preceded by a Phase 1B Dose-Finding, Safety and Tolerability Study of the Combination in All Solid T | II | No prior CT | 919- 668-6728 | 8076 | |
| AstraZeneca | 07085 | A Phase III, Randomized, Double-Blind, Multicenter Study to Assess the Efficacy of Docetaxel (Taxotere) in Combination with ZD6474 (Zactima) verses Docetaxel (Taxotere) in Combination with Placebo in Patients with Locally Advanced or Metastatic (Stage III | III | No prior docetaxel/anti-VEGF | 919- 668-6728 | 00011896 | |
| Lymphomas - Non-Hodgkin's lymphoma and Hodgkin's disease | |||||||
| Duke | A Phase II Study of EL625 in Patients in Persistent Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma | II | 919- 668-6728 | 00001363 | |||
| CALGB | 50102 | CALGB 50102: A Phase III Trial of CHOP vs CHOP+Iodine-131-Labeled Monoclonal Anti-B1 Antibody (Tositumomab) for Treatment of Newly Dx Follicular NHL. | III | Untreated | 919- 668-6728 | 00005405 | |
| Duke | 06110 | A Phase II Study of Bortezomib in Combination with Rituximab, Fludarabine, Mitoxantrone, and Dexamethasone (VR-FND) for Relapsed or Refactory Follicular Lymphoma | II | Treated | 919- 668-6728 | 00008487 | |
| Eli Lily & Co. | A Phase III Clinical Study to Investigate the Prevention of Relapse in Lymphoma Using Daily Enzastaurin | III | RCHOP as 1st line | 919- 668-6728 | 00010668 | ||
| CALGB | 10002 | CALGB 10002: Phase II Study of Rituximab and Short Duration, High Intensity Chemotherapy with G-CSF Support in Previously Untreated Patients with Burkitt Lymphoma/Leukemia. | II | No prior CT | 919- 668-6728 | 00009404 | |
| Yaupon Therapeutics, Inc. | 07038 | A Phase II Pivotal Trial to Evaluate the Safety and Efficacy of Nitrogen Mustard (NM) 0.02% Ointment Formulations in Patients with Stage I or IIA Mycosis Fungoides (MF) | II | Rfrcty to topical RX | 919- 668-6728 | 00007001 | |
| Columbia U. | CHNY-01-501 | Pilot Study of Sequential Myeloablative Stem Cell Transplantation and Reduced Intensity Allogeneic Stem Cell Transplantation Followed by Adoptive Cellular Immunotherapy in Patients with Recurrent/Refractory Non-Hodgkin's Lymphoma and Hodgkin's Disease. | Pilot/Feasibility | Recurrent or refractory | 919- 668-6728 | 00012176 | |
| Genmab | 06052 | An Open-Label, Multi-Center Clinical Trial of HuMax-CD4 in Patients with Mycosis Fungoides Type CTCL (stage Ib-IVb) Who are Refractory or Intolerant to Targretin and Other Standard Therapy | II | Rctry or intolerant to Targretin/std RX | 919- 668-6728 | 00011268 | |
| Melanoma and other skin cancers | |||||||
| A Randomized Phase III Clinical Trial to Evaluate the Efficacy and Safety of Treatment with OncoVEXGM-CSF Compared to Subcutaneously Administered GM-CSF in Previously Treated Melanoma Patients with Unresectable Stage IIIb, IIIc and IV Disease | III | 919- 668-6728 | 00013574 | ||||
| Duke | 02149 | Regional Therapies for Melanoma: The Role of Alkylating Drug Resistance Mechanisms in Malignant Melanoma that May Undermine the Efficacy of Hyperthermic Isolated Limb Perfusion with Melphalan. | N/A | 919 -681-3972 | 00006143 | ||
| New Anti-Cancer Drugs (Phase I) | |||||||
| MethylGene | 265101 | Open-Label, Dose-Escalation Trial to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Daily Oral MGCD265 Administered Without Interruption to Subjects with Advanced Malignancies | I | 919- 668-6728 | 00005540 | ||
| Duke | A Phase I/Biomarker Study of Bevacizumab in Combination with CNTO 95 in Patients with Refractory Solid Tumors | I | 919- 668-6728 | 00004929 | |||
| UNC | LCCC 0717 | A Phase IB Study of Sorafenib for Patients with Locally Advanced or Metastatic Hepatocellular Carcinoma and Child's B Cirrhosis | I | 919- 668-6728 | 00012090 | ||
| TH-CR-402 | A Phase I/II, Multicenter, Dose-Escalation Study to Determine the Safety, Efficacy and Pharmacokinetics of TH-302 in Combination with A) Gemcitabine or B) Docetaxel or C) Pemetrexed in Patients with Advanced Solid Tumors | I/II | 919- 668-6728 | 00009948 | |||
| Duke | A Phase I Study of Bevacizumab, Everolimus and Panitumumab for Patients with Advanced Solid Tumors | I | 919- 668-6728 | 00001082 | |||
| OTHER | 105ST101 | An Open Label Phase I Dose Finding Study of TRC105 in Patients with Advanced or Metastatic Solid Cancer for Whom Curative Therapy is Unavailable | I | 919- 668-6728 | 00004928 | ||
| Enzon | EZN-2968-01 | A Phase I, Open-Label, Dose-Escalation Study Evaluating the Safety and Tolerability of EZN-2968, a Locked Nucleic Acid Antisense Oligonucleotide Against Hypoxia-Inducible Factor-1a (anti-HIF-1a LNA AS-ODN), Administered as a Weekly 2-Hour Intravenous Inf | I | 919- 668-6728 | 00000682 | ||
| OTHER | C11981/1047/ON/US | An Open Label Study to Determine the Oral MTD of the Kinase Inhibitor CEP-11981 in Patients with Advanced Cancer | I | 919- 668-6728 | 00001110 | ||
| Abbott | 05066 | Phase I Study of ABT-510 in Combination with Bevacizumab in Advanced Solid Tumors | I | 3 wk CT window | 919- 668-6728 | 00008797 | |
| Medarex | MDX1307-01 | Phase I, Open Label, Dose-Escalation, Multidose Study of MDX-1307, a Mannose Receptor-Targeted hCG-B Vaccine, in Patients with Incurable Colorectal, Pancreatic or Bladder Cancer. | I | 919- 668-6728 | 00014343 | ||
| ImClone | CP12-0402 | Phase I Study of Every Other Week Anti-Vascular Endothelial Growth Factor Receptor 2 (VEGFR-2) Monoclonal Antibody IMC-1121B in Patients with Advanced Solid Tumors Who have Not Responded to Standard Therapy | I | Treated | 919- 668-6728 | 00009767 | |
| Duke | 07166 | A Phase I/II Study of Active Immunotherapy with CEA(6D) VRP Vaccine (AVX701) in Patients with Advanced or Metastatic Malignancies Expressing CEA | I/II | 919- 668-6728 | 00001799 | ||
| Quality Of Life | |||||||
| Duke-NCI | 03054 | Partner Assisted Emotional Disclosure for GI Cancer | N/A | 919- 668-6728 | 00011905 | ||
| UNC | 05036 | Couple-Based Psychosocial Intervention for Women with Early Stage Breast Cancer. | N/A | 919- 668-6728 | 00006532 | ||
| Sarcomas- Cancers of the bones and soft body tissues | |||||||
| RTOG | A phase II Trial of Image Guided Preoperative Radiotherapy for Primary Soft Tissue Sarcomas of the Extremity | II | 919- 668-6728 | 00007727 | |||
| Duke-NCI | Magnetic Resonance Based Non-Invasive Thermometry for Hyperthermic Treatment of Extremity Soft Tissue Sarcomas: A Multimodal Phase I/II Study. | I/II | Neoadj | 919- 668-6728 | 00008831 | ||