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COLORECTAL and ANAL
Molecular classification Molecular Classification of Colon Cancer as a Clinical Trial Principal Investigator: Dr. Scott Wadler 0102-099
Local rectal cancer CALGB 89901: Phase I/II trial of preoperative treatment with oxaliplatin, fluorouracil (5-FU), and external beam radiation therapy in local rectal cancer. Fluoruracil has been a mainstay of cancer therapy for more than 40 years. Oxaliplatin belongs to a new class of platinum agents that appears to be more cytotoxic than cisplatin and carboplatin and that has been shown to be synergistic with fluorouracil. In this trial, patients receive weekly cycles of intravenous oxaliplatin and 5-FU combined with radiotherapy while their disease is closely monitored. Patients may undergo surgical removal of the rectal tumor following the completion of chemoradiotherapy. Sponsor: Cancer and Leukemia Group B (CALGB) Principal Investigator: Dr. Scott Wadler 0602-326
Monoclonal Antibody Vaccines CALGB 89903: Phase-II study of the antibody vaccines CeaVac and TriAb for patients who have had surgery to remove metastases in the liver after colorectal cancer spread there. Vaccines may make the body build an immune response to tumors; this study tests these two vaccinesí effectiveness in stimulating an immune attack against the cancer cells that remain following surgery. Patients receive injections of the two vaccines four times over 45 days, then monthly for two years, then every other month for three years. Sponsor: Cancer and Leukemia Group B (CALGB) Principal Investigator: Dr. Scott Wadler 0702-367
Avastin and Chemotherapy for Advanced Cancers
ECOG 3200: This phase-II trial compares three regimens for previously treated patients with advanced colorectal cancer: 1) bevacizumab (NSC 704865), oxaliplatin (NSC 266046), fluorouracil (5-FU), and leucovorin; 2) oxaliplatin, fluorouracil, and leucovorin; and 3) bevacizumab alone. Bevacizumab (Avastin) is a humanized monoclonal antibody directed against VEGF (vascular endothelial growth factor). VEGF (pronounced VEJ-eff) is a natural substance that stimulates blood vessel growth and that can be problematic in cancer because an expanded blood supply is essential to the growth of tumors.
Sponsor: Eastern Cooperative Oncology Group
Principal Investigator: Dr. Scott Wadler
0802-406 ECOG
Chemotherapy and Radiotherapy for Anal Carcinoma CALGB 89808: This phase-III randomized study compares the effectiveness of two regimens for carcinoma of the anal canal: fluorouracil and mitomycin-C combined with radiotherapy versus fluororouracil and cisplatin combined with radiotherapy. Although treatment sequencing differs in the two groups, all patients receive radiotherapy five days a week for about five or six weeks. Sponsor: Cancer and Leukemia Group B (CALGB) Principal Investigator: Dr. Scott Wadler 0702-366
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