NCT01150045

Oxaliplatin, Leucovorin Calcium, and Fluorouracil With or Without Celecoxib in Treating Patients With Stage III Colon Cancer Previously Treated With Surgery

A Phase III Trial of 6 Versus 12 Treatments of Adjuvant FOLFOX Plus Celecoxib or Placebo for Patients With Resected Stage III Colon Cancer

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,527 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

PURPOSE: This randomized phase III trial is studying giving oxaliplatin, leucovorin calcium, and fluorouracil together to compare how well they work when given together with or without celecoxib in treating patients with stage III colon cancer previously treated with surgery. RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving oxaliplatin, leucovorin calcium, and fluorouracil is more effective with or without celecoxib in treating colon cancer.

Detailed description

OUTLINE: This is a multicenter study. Patients are stratified according to number of positive lymph nodes\* (1-3 vs 4 or more) and concurrent regular low-dose of aspirin (yes vs no). Patients are randomized to 1 of 4 treatment arms. Please see the "Arms" section for more information. In all arms, treatment with celecoxib or placebo continues for 3 years in the absence of disease progression or unacceptable toxicity. Blood and tissue samples maybe collected for biomarker analysis and pharmacogenomic studies. The primary and secondary objectives for the research study are described below. Primary objective: 1\. To compare disease-free survival of patients with stage III colon cancer randomized to standard chemotherapy only FOLFOX or standard chemotherapy FOLFOX with 3 years of celecoxib 400 mg daily. Secondary objectives: 1. To contribute to an international prospective pooled analysis that will compare disease-free survival of patients with stage III colon cancer randomized to 6 treatments of adjuvant FOLFOX chemotherapy or 12 treatments of adjuvant FOLFOX chemotherapy. 2. To compare overall survival of patients with stage III colon cancer randomized to standard chemotherapy only (FOLFOX) or standard chemotherapy (FOLFOX) with 3 years of celecoxib 400 mg daily. 3. To contribute to an international prospective pooled analysis that will compare overall survival of patients with stage III colon cancer randomized to 6 treatments of adjuvant FOLFOX chemotherapy or 12 treatments of adjuvant FOLFOX chemotherapy or 12 treatments of adjuvant FOLFOX chemotherapy. 4. To assess toxicities of celecoxib as maintenance adjuvant therapy in patients with stage III colon cancer. 5. To assess differences in cardiovascular-specific events with celecoxib versus placebo in a population of stage III colon cancer survivors. 6. To evaluate differences in toxicities, particularly cumulative peripheral neuropathy, for patients treated with 6 treatments of FOLFOX compared to those treated with 12 treatments of FOLFOX. After completion of study therapy, patients are followed up every 6 months for up to 6 years.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	celecoxib	Patients receive celecoxib 400 mg administered by mouth, once daily.
DRUG	5-fluorouracil	Patients receive 400 mg/m\^2 intravenous bolus then 2400 mg/m\^2 continuous intravenous infusion over 46-48 hours.
OTHER	placebo	Patients receive placebo administered by mouth, once daily.
DRUG	oxaliplatin	Patients receive 85 mg/m\^2 intravenous over two hours.
DRUG	leucovorin	Patients receive 400 mg/m\^2 intravenous over two hours.

Timeline

• Start date: 2010-06-01
• Primary completion: 2020-02-28
• First posted: 2010-06-24
• Last updated: 2022-03-22
• Results posted: 2021-08-06

Locations

842 sites across 3 countries: United States, Canada, Puerto Rico