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Alternate Title Phase I/II Study of Dose-Dense and Dose-Intense Capecitabine in Combination With Alternating Full-Dose Irinotecan Hydrochloride and Oxaliplatin With or Without Bevacizumab in Patients With Metastatic or Locally Advanced Unresectable Colorectal Cancer or Other Solid Tumors
Special Category: NCI - CMS pilot project trial Trial Description Drugs used in chemotherapy, such as capecitabine, irinotecan, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Bevacizumab may also block blood flow to the tumor. Giving combination chemotherapy together with bevacizumab may kill more tumor cells. This phase I/II trial is studying the side effects and best dose of capecitabine when given together with irinotecan and oxaliplatin with or without bevacizumab and to see how well they work in treating patients with metastatic or locally advanced colorectal cancer or other solid tumors that cannot be removed by surgery. Eligibility criteria include the following:
Final eligibility for a clinical trial is determined by the health professionals conducting the trial. Patients will receive capecitabine by mouth twice a day for 7 days. Treatment with capecitabine may repeat every other week for as long as benefit is shown. They will receive a 1½-hour infusion of irinotecan in weeks 1 and 3. Treatment with irinotecan may repeat every 8 weeks. Patients will also receive a 2-hour infusion of oxaliplatin in weeks 5 and 7. Treatment with oxaliplatin may repeat every 8 weeks. Some patients will also receive 30- to 90-minute infusion of bevacizumab every 2 weeks. After finishing treatment, patients will be evaluated periodically. Important: For more details about this trial, refer to the Health Professional version of the trial summary. If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site. Trial Lead Organizations Case Comprehensive Cancer Center
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