Anti-Cancer Drugs for Off-Label Indications
in Selected NCI Clinical Trials
The expanded coverage program (earlier page) applies to specific drugs in specific trials. Below is the list provided by Medicare.
We are adding information about these drugs (this will take a couple of days). Jump to the bottom of the Medicare list. So far, just one abstract about Bevacizumab [Avastin].
"Common toxicities associated with bevacizumab include hypertension, bleeding episodes, and thrombotic events." We aim to find out if these Medicare-supported trials will provide patients with adequate protection by means of secondary drugs to control side effects.
DRUGS
oxaliplatin (Eloxatin®), irinotecan (Camptosar®), bevacizumab (Avastin&TM;), and Cetuximab (Erbitux&TM;).
TRIALS
Medicare says "Use the search form at NCI web page for details of these trials. The regular search for is hard to use. Use the advanced form, which our link above will take you to, so you can enter the PROTOCOL NUMBER e.g. 6660:
http://www.cancer.gov/Search/SearchClinicalTrialsAdvanced.aspx
-
660 is a two-phase study:
Phase I will determine MTD and DLT evaluating the use of bevacizumab in carcinoma of the GI tract, breast, and ovary. It compares the use of capecitabine, irinotecan and bevacizumab; with capecitabine, oxaliplatin and bevacizumab.
Phase II is a first-line treatment of metastatic colorectal cancer. Use MTD from phase I portion of the trial in patients with locally advanced or metastatic colorectal cancer.
- C80405 is a phase III, first-line metastatic colorectal cancer trial. It consist of 3 arms: FOLFOX, FOLFIRI, CAPOX, CAPIRI plus bevacizumab; FOLFOX, FOLFIRI, CAPOX, CAPIRI plus etuximab (Erbitux); and FOLFOX, FOLFIRI, CAPOX, CAPIRI plus both bevacizumab and etuximab (Erbitux).
- E2204 is a phase II trial evaluating bevacizumab in an adjuvant setting for the treatment of pancreatic cancer. This study consist of 4 arms: surgery plus bevacizumab; surgery plus etuximab (Erbitux); etuximab (Erbitux) plus gemcitabine, capecitabine and radiation treatment; and bevacizumab plus gemcitabine, with capecitabine and radiation treatment.
- E3201 is a phase III clinical trial for patients with rectal cancer in an adjuvant setting. The trial design consists of four arms: 5-FU/LV (or FOLFIRI); 5-FU/LV (or FOLFIRI) plus bevacizumab; FOLFOX; or FOLFOX plus bevacizumab.
- E4203 is a phase II, first line therapy for metastatic colorectal cancer study based on tumor thymidylate synthase expression in previously untreated patients with metastatic colon cancer. The study consists of two arms, comparing patients treated with irinotecan, oxaliplatin, and bevacizumab with patients treated with oxaliplatin and bevacizumab.
- E5202 is a phase III clinical trial using bevacizumab in an adjuvant setting for patients with colon cancer. Molecular markers on tumors are used to place stage II patients in high or low risk categories. The low risk patients are observed, the high-risk patients are randomized to MFOLFOX6 + or - bevacizumab (treatment arms are identical to NSABP C-08).
- RTOG-H0429 is a phase III trial evaluating the use of cetuximab (Erbitux) in head and neck cancers. This study compares the use of AFX-CB or IMRT plus
cetuximab (Erbitux)
and CDDP to AFX-CB or IMRT plus CDDP.
- NSABP R-04 is for rectal cancer adjuvant setting for patients with stage II/III disease. The design consist of 2 arms: radiation with capecitabine +/- oxaliplatin, and the other arm consists of radiation with 5-FU CVI +/- oxaliplatin.
- SWOG 0502 is a phase II clinical trial assessing two dose levels of bevacizumab, combined with imatinib, in patients with advanced, incurable gastrointestinal stromal tumors.
FOLLOW UP INFORMATION --To be added to --
Bevacizumab: an angiogenesis inhibitor with efficacy in colorectal and other malignancies. Zondor SD, Medina PJ. College of Pharmacy, University of Oklahoma Health Sciences Center, Oklahoma City, OK.
Ann Pharmacother. 2004 Jul-Aug;38(7-8):1258-64. Epub 2004 Jun 08. "Bevacizumab [Avastin] is the first anti-cancer agent shown to provide benefit for patients with cancer by inhibiting angiogenesis. Bevacizumab has shown significant activity in the treatment of many cancers, including metastatic colorectal cancer. When used in combination with fluorouracil-based chemotherapy, bevacizumab improves overall response rates, time to progression, and survival in patients with metastatic colorectal cancer. Common toxicities associated with bevacizumab include hypertension, bleeding episodes, and thrombotic events. CONCLUSIONS: Although clinical knowledge on the effectiveness of bevacizumab is limited, early data indicate that it is a promising agent, with a novel mechanism of action, for patients with metastatic cancer, including colorectal cancer."
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Edited by J. Strax, Nov 5 2004.
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