drugset / Trial / NCT00217737

Oxaliplatin, Leucovorin, and Fluorouracil With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for Stage II Colon Cancer

NCT00217737 ↗

Phase 3 Active not recruiting 2431 enrolled National Cancer Institute (NCI)
RandomizedParallel-groupOpen-labelTreatment

Summary

This randomized phase III trial studies oxaliplatin, leucovorin, fluorouracil, and bevacizumab to see how well they work compared to oxaliplatin, leucovorin, and fluorouracil in treating patients who have undergone surgery for stage II colon cancer. 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, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving combination chemotherapy together with bevacizumab is more effective than combination chemotherapy alone in treating colon cancer.

Timeline

Start
2005-09-06
Primary completion
2024-02-22
Completion
2027-04-11

Outcome

Missed primary endpoint

registry Hazard Ratio (HR) 0.83 (95% CI 0.63 to 1.11) NCT00217737 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody — Intravenous
Subject Leucovorin Small molecule — Intravenous
Subject Oxaliplatin Small molecule — Intravenous
Subject fluorouracil Small molecule — Intravenous

Indications