CALGB 80702: A Phase 3 Trial of 6 versus 12 Treatments of Adjuvant Folfox Plus Celecoxib or Placebo for Patients with Resected Stage III Colon Cancer
Open to Enrollment
This is a study for patients with colon cancer that has been surgically removed but has spread to lymph nodes.
The purpose of this study is to evaluate the efficacy of the oral drug celecoxib when given in combination with FOLFOX chemotherapy in decreasing colon cancer recurrence. The study will also look at whether receiving FOLFOX chemotherapy for 6 treatments (12 weeks) is as effective as 12 treatments (24 weeks) in preventing recurrence of colon cancer.
FOLFOX is approved by the FDA and is standard treatment used to prevent colon cancer from recurring. Celecoxib is approved by the FDA to treat arthritis and to help prevent colon polyps. The addition of celecoxib to FOLFOX therapy is experimental.
Patients will be randomized to one of four treatment groups: g
- Group 1: FOLFOX for 12 treatments (24 weeks) + placebo (a substance containing no medicine that looks like celecoxib) by mouth every day for 3 years
- Group 2: FOLFOX for 12 treatments + celecoxib by mouth every day for 3 years
- Group 3: FOLFOX for 6 treatments (12 weeks) + placebo by mouth every day for 3 years
- Group 4: FOLFOX for 6 treatments + celecoxib by mouth every day for 3 years
Patients will be treated with FOLFOX chemotherapy for up to 6 treatments (12 weeks) or 12 treatments (24 weeks), depending on which treatment arm they are assigned to, and will take celecoxib or placebo for up to 3 years.
Disease Status and/or Stage
Resected Stage 3 Colon Cancer
- Colon cancer
- Tumor must be completely resected (removed)
- Treatment must begin between 21 and 56 days after surgical resection of tumor
- Detailed eligibility reviewed when you contact the study team
- Alice Mercado, RN
- (212) 746-5430
WCMC IRB #1112012061; Sponsor Protocol #CALGB 80702
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