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STEAM: Folfoxiri/Bevacizumab Regimens vs. Folfox/Bevacizumab in Colorectal Cancer
Colorectal Cancer - STEAM (Sequencing Triplet with Avastin and Maintenance): Folfoxiri/Bevacizumab Regimens (Concurrent and Sequential) vs. Folfox/Bevacizumab in First-Line Metastatic Colorectal Cancer
Colon Cancer, Colorectal Cancer
||Wasif Saif, MD
||Jennifer Caplain, RN
The purpose of this study is to find out what effects, good or bad, bevacizumab combined with different cancer drugs known as chemotherapy has on participant and the metastatic colorectal cancer (cancer which has spread from the colon or rectum). Participant will initially receive bevacizumab combined with one of three chemotherapy treatments: concurrent FOLFOXIRI (all drugs will be administered during the same treatment cycle) or sequential FOLFOXIRI (some drugs will alternate on a monthly basis) or the commonly used FOLFOX chemotherapy treatment. Throughout the course of this study, participant’s chemotherapy will be modified with some of the cancer drugs discontinued, reintroduced, or replaced. Participant will be notified of all changes by the study doctor or study staff.
- If fertile, males must agree to a highly effective contraceptive method (i.e., witha failure rate of < 1 % per year, such as vasectomy, sexual abstinence, or female partner's use of hormonal implants or combined oral contraceptives) during the trial and 6 months after last dose of bevacizumab.
- Adequate liver, hematological and renal functions
- Participants who are pregnant or breastfeeding
- Participant with a history of abdominal fistula, GI perforation, or intra abdominal abscess within 6 months of randomization
- Participant with serious non-healing wound, active peptic ulcer, or untreated bone fracture
This study will involve blood draw, archival tumor tissue will also be collected if you decide to participate in the optional biomarker program, complete physical history to measure your vital signs. The overall length of the study is planned to be approximately 5 years after first enrollment, inclusive of the 28-day and 3-month safety visits. The sponsor would like to keep track of participant medical condition for the rest of their life. This will be done by asking participant to visit the office for follow-up examinations or by calling on the telephone every 3 months; even after participant have completed regular study visits.