Postoperative Chemotherapy With or Without Bevacizumab for Patients With Stage II or III Rectal Cancer
Summary
Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving more than one drug (combination chemotherapy) together with bevacizumab after surgery may kill any tumor cells that remain after surgery. It is not yet known whether oxaliplatin, leucovorin, and fluorouracil is more effective with or without bevacizumab in treating rectal cancer. This randomized phase III trial is studying combination chemotherapy to see how well it works with or without bevacizumab in treating patients who have had surgery for stage II or stage III rectal cancer.
Timeline
- Start
- 2006-05-11
- Primary completion
- 2015-04
- Completion
- 2019-02-11
Outcome
Missed primary endpoint
Stopped (Enrollment): “The study was terminated before reaching its accrual goal due to slow accrual.”
registry analysis (unspecified test); Arm I (Oxaliplatin, Fluorouracil, Leucovorin) vs Arm II (Oxaliplatin, Fluorouracil, Leucovorin, Bevacizumab); p = 0.876; Log Rank NCT00303628 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | — | Intravenous |
| Subject | Oxaliplatin | Small molecule | — | Intravenous |
| Subject | fluorouracil | Small molecule | — | Intravenous |
| Background | Leucovorin | Small molecule | — | Intravenous |