Duke Cancer Protocol Fast Facts
Duke Comprehensive Cancer Center
Clinical Trials at Duke Comprehensive Cancer Center
May 13, 2008
| Breast Cancer | |||||||
| Sponsor | Sponsor ID | Protocol | Phase | Eligibility | Contact | IRB# | |
| CALGB | 07182 | CALGB 60202 | III | 660.1278 | 4063 | ||
| CALGB | 40101 | Adj, LN-: CA (4 vs 6 cycles) vs Taxol (12 vs 18 wks) | III | ADJ | 660.1278 | 4063 | |
| CALGB | 49805 | Adj, TAM x 5 yrs, postmen, ER+: Letrozole vs placebo | III | Adj CT/RT ok | 660.1278 | 0456 | |
| Duke-NCI | 03019 | ADJ, AC &/or wkly Taxol: Pharmacogenomics | N/A | ADJ | 660.1278 | 4522 | |
| ACOS | ACOSOG Z1031 | Neoadj, stages 2/3: Exemestan vs letrozole vs anastrozole | III | ER+, post-men | 660.1278 | 8603 | |
| Duke-Komen | 06068 | Recurrent, local/regional: ThermodoxHyperthermia | I/II | Recurrent | 660.1278 | 6883 | |
| Wyeth-Ayerst | 07076 | Stages IIIB/C, IV, HER2+, progressed: HKI-272/Herceptin | I/II | Progression post Herceptin-CT | 660.1278 | 9550 | |
| Washington U. | 04146 | Stage IV, post, E/PR +,stablex2yrs: Estradiol (intermed vs hi dose) | II | Prior aromatase in. | 660.1278 | 5782 | |
| Duke-Komen | 06065 | Stage IV: Weekly Taxol + Panzem | I | No prior weekly Taxol | 660.1278 | 8203 | |
| Bionovo, Inc. | 07086 | Stage IV, 3rd line: BZL101 | I/II | <=2 prior CT; any # hormones | 660.1278 | 9610 | |
| GSK | EGF104900 | Stage IV, progressed: Lapatinib +/- Herceptin | III | Herceptin/CT progression | 660.1278 | 7920 | |
| Genen | AVF3693g | Stage IV, prev. treated: Bevacizumab + CT | III | Treated | 660.1278 | 9260 | |
| Duke-Abraxis BioScience and Genentech BioOncology | 07103 | Stage IV,/inop stIII, triple negative: Abraxane/carboplatin/AVASTIN | II | No prior study drugs or taxanes | 660.1278 | 9598 | |
| GW | EGF10027 | Untreated, EGFRor ErbB2+: GW57201 PK study (3 dosing regimens) | I | >=2cmtumor; untreated | 660.1278 | 5518 | |
| GW | EGF103009 | Inflammatory, relapsed/refractory: Lapatinib | II | ErbB1/2+ | 660.1278 | 6742 | |
| Duke-GENENTECH | 07090 | Brain metastases: AVASTIN + std CT | II | Any # prior CTs out 2 wks | 660.1278 | 9597 | |
| Reata Pharmaceuticals, Inc. | 07228 | Brain Mets, RTA 744 | II | Progressed after whole brain irradiation | 660.1278 | 2106 | |
| Duke-DOD | 07198 | Genomic Expression Profiles to Direct Preoperative Chemo Early Breast | II | T1C (over 1.5cm) to T3 invasive HER2 Neg. No mets | 660.1278 | 1345 | |
| Brain Cancer | |||||||
| Duke-GENENTECH | 07151 | GBM/gliosarcoma, new dx: Avastin/RT/TMZ>Avastin/TMZ/CPT | II | 2-4 wks from surgery | 684.5301 | 0458 | |
| Novacea | 07126 | GBM, new dx (IA): AQ4N + TMZ + RT | II | No prior RT or CT | 684.5301 | 0305 | |
| Duke-NCI | 06042 | GBM, newly dx: CMV pp65-LAMP RNA | I/II | <6 weeks prior resection | 684.5301 | 8108 | |
| Duke-NCI | 07176 | Resid, recur or progres primary; Immunotoxin, protein MR1-1 | I | 684.5301 | 7669 | ||
| Duke-NIH | 07112 | GBM: TMZ/RT>TMZ>DCs+ALT + daclizumab/TMZ | I | New diagnosis | 684.5301 | 0581 | |
| Duke | 05029 | GBM, supratentorial,recurr/prog: Temodar/O6-BG x 5 days | I | 4-6 wk prior CT window | 684.5301 | 6788 | |
| Duke-NIH | 07220 | GBM, Newly diagnosed. Daclizumab +ALT vs. ALT + Vaccine | I | Leukapheresis within 4 wks of resection, XRT/Temo | 684.5427 | 0947 | |
| Amgen | Glioma, stage IV: AMG102 | II | <=3 prior relapses | 684.5301 | 0279 | ||
| Duke-Schering Plough | 05162 | Glioma recurrent,grade 3 or 4: Ph I SCH 66336 + Temodar | I | 3-6 week prior RX window | 684.5301 | 7009 | |
| Duke-GENENTECH | 07138 | Glioma, recurrent: AVASTIN + metronomic TMZ | II | Allows prior failure 5-d TMZ | 684.5301 | 0404 | |
| Duke-AstraZeneca | 07215 | Glioma, Recurrent Zactima+Gleevec+Hydroxyurea | I | 1st, 2nd or 3rd recurrence or relapse | 684.5301 | 0393 | |
| Duke-NOVARTIS | 05089 | LGG,grade 2, recurr/progressive: Gleevec/Hydroxyurea | II | 4 wks from prior CT/RT | 684.5301 | 7262 | |
| EMD Pharmaceuticals | EMD 121974-009 | GBM,recurrent: Cilengitide (2 dosages) | II | <= 1 prior CT | 684.5301 | 6486 | |
| Duke-GENENTECH | 07080 | GBM, recurr: Erlotinib + Sirolimus | II | No prior anti-MTOR or EGFR RX | 684.5301 | 0345 | |
| EntreMed | 06030 | GBM, 1st or 2nd recurrence: PO panzem | II | 4 wk CT window | 684.5301 | 7999 | |
| NABTC | NABTC 04-01 | GBM, recurrent: GW572016 | II | <= 3 recurrences | 684.5301 | 7869 | |
| Duke-GENENTECH | 07017 | GBM, recurrent: BEV/erlotinib | II | Recurrent disease | 684.5301 | 0220 | |
| Duke-GENENTECH | 07043 | GBM, recurrent: AVASTIN + etoposide | II | <=3 prior recurrences | 684.5301 | 0379 | |
| EntreMed | 07101 | GBM, recurrent: PANZEM + Temodar | II | 4 wk window prior RT/CT | 684.5301 | 0517 | |
| NOVARTIS | 06055 | GBM, progressive: Glivec + Hydroxyurea | II | Not on EIACDs | 684.5301 | 8205 | |
| NOVARTIS | 06056 | GBM, progressive: Glivec + Hydroxyurea | II | Receiving EIACDs | 684.5301 | 8204 | |
| Duke-Bayer Healthcare | 07217 | GBM, recurrent/progressive, Sorafenib + Temozolomide | II | 1st, 2nd, or 3rd relapse. Need prior XRT | 684.5301 | 0464 | |
| Duke-NOVARTIS | BUS221 | Meningioma,recurr/progress : Gleevec + Hydroxyurea | II | Recurrent or progressive | 684.5301 | 7082 | |
| Duke-GENENTECH | 07200 | Avastin + Temozolomide | II | Unresect or mulitfocal, no prior radiothera/chemo | 684.5301 | 1022 | |
| Gynecological Cancers - Ovarian cancer and cancers of the female organs | |||||||
| Duke-Bristol-Myers Squibb | 07152 | Ovary, peritoneal or tubal, advd: Dasatinib + Taxol/carboplatin | I | <= 3 prior CTs | 681.3792 | 9311 | |
| Lilly | B9E-US-S302(D) | Ovarian, fallopian, peritoneal: Gem/Carbo vs Taxol/Carbo (crossover) | III | No prior CT | 681.3792 | 6451 | |
| Sanofi-Synthelabo | PML0239 | Ovary, st IB-IV: Oxaliplatin/docetaxel/bevacizumab | II | First line | 681.3792 | 8423 | |
| Menarini Ricerche S.p.A | 07130 | Ovarian, stages 3-4, CR post CT/surg: Abagovomab/placebo maint | II | DDP-based CT | 681.3792 | 9352 | |
| GOG | GOG 0212 | Ovary, peritoneal stage III: Maint: Taxol or Xyotax vs no RX | III | CR on 1st line DDP/Taxane CT | 681.3792 | 7109 | |
| GOG | 0218 | Ovarian, peritoneal, stage III/IV: Carbo/DDP +/- Avastin/placebo | III | No prior CT/RT | 681.3792 | 7947 | |
| GOG | 146-N | Ovarian recurr,DDP-sensitive: PS-341 | II | Prior DDP | 681.3792 | 3415 | |
| GOG | GOG-0170J | Ovary or primary peritoneal: Enzastaurin | II | Recurr. or persistant disease | 681.3792 | 9575 | |
| Unither | OVA-Gy-17(A) | Ovarian,tubal,peritoneal, stages III-IV: OvaRex/placebo (blinded) | III | Second line | 681.3792 | 4844 | |
| Duke-Immunotope | 07083 | Ovary, stages III-IV, debulked: Ovarian peptides/GM/montanide consol. | I | CR to platin/taxane CT | 452.3367 | 9414 | |
| GOG | 187 | Ovary, stromal cell: Taxol | II | 1st or 2nd line | 681.3792 | 2605 | |
| Duke-NCI | 03056 | Cervix, stage IIb-IVa: CT/RT+/- HT | III | No prior CT or RT | 668.3034 | 4516 | |
| GOG | 0219 | Cervix, limited to pelvis: RT/DDP +/- tirapazamine | III | Stages IB2, IIA, IIB, IIIB, IVA | 681.3792 | 8462 | |
| GOG | 0127-U | Cervix, recurr/persist: Topotecan Hydrochloride | II | 1 prior CT | 681.3792 | 7045 | |
| GOG | 209 | Endometrium:stages III/IV or recurr: Dox/DDP/Taxol/GCSF vs Carbo/Taxol | III | No prior CT | 681.3792 | 5039 | |
| GOG | 0129P | Endometrium recurr/persis:Exabepilone | II | 1 prior CT | 681.3792 | 7665 | |
| GOG | 131-G | Uterine leiomyosarcoma, recurr/persis: Docetaxel/gem + G | II | 1 prior CT | 681.3792 | 3652 | |
| GOG | 230-B | Uterine carcinosarcoma, recurr/persis: Thalidomide | II | 1 prior CT | 681.3792 | 3350 | |
| GOG | 0103 | Uterine Carcinosarcoma,Recurr/Persis:GEM/docetaxel | II | 1 prior CT | 681.3792 | 7108 | |
| GOG | 232-B | Uterine carcinosarcoma,stage III/IV,recurr/persist: Taxol > Carbo | II | No prior cytotoxic CT | 681.3792 | 7800 | |
| GOG | 205 | Vulva, locally adv,squamous cell: RT/ wkly DDP | II | Untreated | 681.3792 | 5431 | |
| Lung Cancer | |||||||
| CALGB | CALGB 150504 | CALGB 150504 | II | 681.4768 | 8149 | ||
| CALGB | 07187 | CALGB 150505 | II | 681.4768 | 8017 | ||
| Duke | 07153 | NSC, stages IB-II: Adjuvant CT + tailored RT | II | DDP-doublet CT post-op | 668.3034 | 0981 | |
| Duke | 06069 | NSC, stage III, neoADJ, genomic sigs: DDP/Docetaxel | II | No prior CT | 681.4768 | 8217 | |
| Duke-LILLY | 07093 | NSC, stages IIIB/IV: Genomics selected GEM+DDP or ALIMTA | II | No prior CT | 681.4768 | 4599 | |
| Duke-AVENTIS | 0402 | NSC,stage IV: Docetaxel/DDP/STI571 | I/II | No prior CT | 681.4768 | 5999 | |
| CALGB | 30406 | NSC, stage IIIB/IV:Erlotinib +/- Taxol/Carboplatin | II | No prior CT | 681.4768 | 8149 | |
| Pfizer | A5301005 | NSC, stages IIIB/IV: Docetaxel +/- CP868,596 | II | No prior CT | 681.4768 | 8076 | |
| UT-Genentech | 07121 | Mesothelioma: DDP/pemetrexed/AVASTIN | II | Untreated | 681.4768 | 0612 | |
| Gastrointestinal Cancers - Colorectal cancers and cancers of the stomach, esophagus and other digestive organs | |||||||
| Duke-Bristol-Myers Squibb | 05125 | CRC,stage IV or recurr: Oxaliplatin/Capecitabine/Cetuximab/Bevacizumab | II | No prior stage IV CT | 684.3362 | 7118 | |
| CALGB | 80405 | CRC, stage IV: FOLFOX or FOLFIRI+AVASTIN or Cetux or AVAS/Cetux | III | Untreated | 684.3362 | 5345 | |
| Duke-NCI | 04145 | NeoADJ rectal: Phase I AVASTIN/5-FU/RT | I | Lclly advd or unresect | 684.3362 | 6042 | |
| Duke-GENENTECH | 07108 | Esophagus or stomach, advd or recurr: | II | No prior CT | 684.3362 | 8797 | |
| Exelixis, Inc. | 07118 | Gastric, advd, PDD: XL880 | II | <=1 prior CT | 684.3362 | 0864 | |
| NOVARTIS | 07120 | Pancreatic NET, advd: RAD001 | II | Min. 3 mos CT or Sandostatin progression | 452.3367 | 8955 | |
| Genitourinary Cancers - Prostate cancer and cancers of the kidney, bladder, and male organs | |||||||
| CALGB | 07189 | CALGB 150403 | III | 668.7531 | 7514 | ||
| Duke | 07159 | Prostate, intrmd/hi risk, localized: Cryotherapy>RT | I | No prior RX | 668.7531 | 9087 | |
| Duke | 05058 | Prostate, hi risk,localized: RT dose-escalation > prostatectomy | I | High risk | 668.3034 | 7028 | |
| Dana-Farber Cancer Institute | 07133 | Prostate, hi-risk(T3), neoadj: AVASTIN + docetaxel>surgery | II | NO prior RX, PSA>=20 | 668.3613 | 0181 | |
| Sanofi-Synthelabo | XRP6976J | Prostate, hi risk post resect: Immediate vs delayed Eligard+/-TAX | III | No prior CT/RT | 668.7531 | 0100 | |
| RTOG | 0415 | Prostate, T1-2: Hypofractionated RT Vs. Conventionally Fractionated RT | II | No prior RX | 668.3034 | 9112 | |
| Duke-NOVARTIS | 05138 | Prostate, stage IV, hormone-rfcty: Everolimus | II | 4 wk prior therapy window | 668.7531 | 7521 | |
| Dendreon Corporation | 07136 | Prostate, advd, androgen-independent: Provenge/placebo | III | PSA>=5.0 | 668.7531 | 0309 | |
| Duke-Damon Runyon Research Foundation | 07036 | Prostate, stage IV, hrmn-rfcty: Docetaxel (genomic signature) | II | No prior docetaxel/Taxol | 668.7531 | 9159 | |
| Pfizer | 07078 | Prostate, advd, hrmn-rfcty, progressive: SU011248/docetaxel/pred | I/II | No prior CT | 668.7531 | 8833 | |
| CALGB | 90202 | Prostate ca, bone mets: Zometa vs placebo (blinded) | III | No prior bisphosphonates | 668.7531 | 7514 | |
| Pfizer | A6181039 | RCC, stage IV, AVASTIN-refractory: SU011248 | II | <= 2 prior CT regimens | 668.7531 | 6715 | |
| Pfizer | A618006P | RCC,mets,cytokine-refractory: SU011248 | II | One prior cytokine | 668.7531 | 5794 | |
| Duke-NOVARTIS | 07218 | RCC metastatic, RAD001 + Sunitinib | I | Clinical or radiographic evidence of mets | 668.7531 | 0548 | |
| NOVARTIS | 07164 | RCC mets, VEGF progression; RAD001 vs Best Supportive Care + Placebo | III | 668.7531 | 0847 | ||
| Viventia Biotech, Inc | 07206 | Intravesical Vicinium for Non-invasive Urothelial Carcinoma In Situ | II | Failed previous BCG | 668.7531 | 1275 | |
| Head and Neck Cancers- Cancers of the larynx, mouth, and throat area | |||||||
| Duke-GENENTECH | 05101 | Stages II-IV, M0: AVASTIN +/- Erlotiniib > RT/CT> surg (opt) | Pilot | No prior treatment | 668.3034 | 7077 | |
| RTOG | 07041 | Locally advd, mucositis 2ndary to RT/CT: Palifermin | III | Non-metastatic disease | 668.3034 | 0530 | |
| Leukemia and multiple myeloma | |||||||
| CALGB | 07181 | CALGB 60303 | II | 681.4769 | 5783 | ||
| CALGB | 07192 | CALGB 20302 | II | 681.4769 | 7532 | ||
| Scott & White Mem Hosp | 03151 | AML,relpsd/refrcty: DT388IL3 | I | Treated | 681.4769 | 5073 | |
| Merck | 06053 | AML, relpsd/refrcty: 5-d CI L-001281814 | I/II | Treated | 681.4769 | 8260 | |
| Genzyme Corporation | CLO34100405 | AML, rfcty, >60yrs: ARA-C +/- clofarabine | III | <=2 prior inductions | 681.4769 | 8523 | |
| Duke-Cell Therapeutics | 07013 | MM, rlpsd: Trisenox/AA/Velcade | I/II | No prior Trisenox | 681.4769 | 7365 | |
| Clavis Pharma | Hem malig, rlpsd/rfcty: CP-4055 | I/II | Relapsed or refractoy disease | 681.4769 | 9182 | ||
| Lilly | 06085 | AML: Gemcitabine/Mitoxantrone | II | 1st relapse | 681.4769 | 7879 | |
| Duke | 06035 | ANLL/ALL/CML/MDS: UCBT>Thymus transplant | I | No UCB identical or 5/6 donor | 681.4769 | 7343 | |
| Duke | 07026 | MDS: Sorafenib | II | No prior alloSCT | 681.4769 | 8662 | |
| Duke | 07035 | MDS: Trisenox/AA/decitabine | II | 4 wk prior therapy window | 681.4769 | 9193 | |
| Lymphomas - Non-Hodgkin's lymphoma and Hodgkin's disease | |||||||
| CALGB | 50102 | NHL,new dx follic,stages II/III/IV:CHOPvs(CHOP/Ritux)vs(CHOP/Tositumo) | III | Untreated | 681.4769 | 5405 | |
| Millennium | 06110 | NHL, follicular: Bortezomib/Rituximab/Fludarabine/DHAD/VR-FND | II | Treated | 681.4769 | 8785 | |
| Duke-NOVARTIS | 05140 | DLCL, refractry,relpsed: PTK787/ZK222584 | II | 3 wk prior CT window | 681.4769 | 7416 | |
| CALGB | 10002 | Burkitt lymph/leuk: Rituximab/Hi Intensity CT/G-CSF | II | No prior CT | 681.4769 | 3993 | |
| Yaupon Therapeutics, Inc. | 07038 | CTCL(MF), stages I/IIA: NM ointment | II | Rfrcty to topical RX | 668.5615 | 8630 | |
| MethylGene | 07173 | Relapsed & Refractory Lymphoma; MGCD0103 | II | measurable disease | 681.4769 | 9233 | |
| Columbia U. | CHNY-01-501 | NHL/Hodgkin;s, recurr/refrcty,<55: autoSCT>alloSCT>cellular immunotx | Pilot | Recurrent or refractory | 668.6536 | 4498 | |
| Genmab | 06052 | CTCL, stage Ib-IVb : HuMax-CD4 | II | Rctry or intolerant to Targretin/std RX | 668.5615 | 6482 | |
| Sarcomas- Cancers of the bones and soft body tissues | |||||||
| EORTC | EORTC 62961 | ST Sarcoma, hi risk: Neoadj VP-16/ Ifos/ Dox +/- HT | III | Neoadj | 668.3034 | 1305 | |
| Duke-NCI | 00016 | Ext ST-Sarcoma: Neoadj Ifos/RT/MRI-HT/DOX | I/II | Neoadj | 668.3034 | 1308 | |
| New Anti-Cancer Drugs (Phase I) | |||||||
| Duke-NOVARTIS | 05010 | Solid tumors: PTK/RAD | I | 4-6 wk CT window | 668.7531 | 6626 | |
| Duke-ABBOTT | 05066 | Solid tumors: ABT-510/Avastin | I | 3 wk CT window | 684.3362 | 6074 | |
| ImClone | 06071 | Solid Tumors: IMC-1121B | I | Treated | 684.6342 | 7682 | |
| BMT and Cellular Therapies | |||||||
| Duke | 05075 | Hem/solid, post mismatch miniALLO: NK Cell DLIs | Pilot | <= grade 2 acute GvHD | 681.4769 | 6915 | |
| Duke-NCI | 02139 | Hem/solid/BM failures: Campath/flu/CTX mismatch sibs stem cells | II | Dx-dependent | 681.4769 | 3991 | |
| Duke | 07161 | Heme Malig; candidate for HLA identical or matched allo transplant | I/II | 681.4769 | 0993 | ||
| Duke-NCI | 04117 | CRC,resected liver mets:PANVAC vs DC/PANVAC | II | NED | 452.3367 | 5883 | |
| Duke-Immunotope | 07127 | HIgh risk (TxN2-3,M0) or stage IV: Cancer peptides + GM-CSF | I | NED post adj CT or Herceptin | 452.3367 | 0902 | |
| Duke-NCI | 05054 | Advd,met malig,CEA+: Ph I ONTAK > DCs infected w/ TRICOM | I | Prior CT | 452.3367 | 6686 | |
| Duke-NCI | 04030 | Adv ca, prior CEA DC vaccine: Interferon alfa | Pilot | 1-4 wks post DCs | 452.3367 | 5656 | |
| Duke-NCI | 04077 | Stage IV or loc adv: MDX-1307 (hCG beta vaccine) | I | <=2 prior CTs | 452.3367 | 5832 | |
| Medarex | MDX1307-01 | Colorectal, Pancreatic, Bladder: Phase I MDX-1307 vaccine | I | <=2 prior CTs (hCG-beta+) | 452.3367 | 5673 | |
| Duke-AMGEN | 99101 | Hemoglobinopathies/Bone Marrow failure: Campath/fludara/CTX > allo-BMT | II | Treated | 681.4769 | 1224 | |
| Duke-NCI | 02118 | Refrty hem/solid: Mini-allo: CAMPATH/flu/CTX>matched sib PBSCs | II | Treated | 681.4769 | 3768 | |
| Duke-NCI | 07142 | Hem malig, B-cell (AML,CML,ALL, MDS), post BMT: WT1 peptides | I | WT1 positive | 452.3367 | 1360 | |
| Duke-NIH | 07166 | CEA expressing tumors; CEA(6D) or AVX701 Vaccine | I/II | 452.3367 | 1799 | ||
| Duke-Enzon Pharmaceuticals | 07167 | Active Lymphomatous or Leukemic Meningitis: IT DepoCYT | II | 681.4769 | 9010 | ||
| Duke Cancer Care Research Program | |||||||
| Pfizer | Pilot Study Efficacy & Feasibility of Pathfinders for MBC | Pilot | 660.1278 | 9179 | |||
| Quality Of Life | |||||||
| Duke | 07208 | Partner-Guided Pain Management Training for Advanced Cancer Patients | N/A | 416.3471 | 1700 | ||