Study:
Intergroup Randomized Phase III Study of Postoperative Oxaliplatin, 5-Fluorouracil and Leucovorin vs Oxaliplatin, 5-Fluorouracil, Leucovorin and Bevacizumab for Patients With Stage II or III Rectal Cancer Receiving Pre-operative Chemoradiation
Rationale:
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.
Purpose:
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.
Study Status: Terminated
Recruiting:
n/a
| Condition |
Intervention |
Phase |
Adenocarcinoma of the Rectum
Stage II Rectal Cancer
Stage III Rectal Cancer |
Drug: oxaliplatin
Drug: fluorouracil
Drug: leucovorin calcium
Drug: bevacizumab
Procedure: laboratory biomarker analysis |
Phase 3 |
Verified by
National Cancer Institute (NCI)
April, 2013
Sponsored by: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov identifier: NCT00303628
Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States
Cleveland Clinic Cancer Center Independence
Independence, Ohio 44131
United States
Cleveland Clinic Wooster Specialty Center
Wooster, Ohio 44691
United States
Al Benson., Principal Investigator