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Colon Cancer

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CALGB 80702

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

Last Modified: 6/5/2012 First Published: 6/22/2010

Trial Description

Purpose:

Drugs used in chemotherapy, such asoxaliplatin, leucovorin calcium, andfluorouracil, 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.

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 cancerpreviously treated with surgery.

Eligibility:

Eligibility criteriainclude the following:

  • At least 18 years of age
  • No evidence of residual disease involving a lymph node or metastatic disease
  • For more information about the eligibility criteria for this trial, refer to the Health Professional version. 1

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will be randomly assigned (have an equal chance of being placed) to 1 of 4 treatment groups.

Patients in group one will receive a 2-hour infusion of oxaliplatin, a 2-hour infusion of leucovorin calcium, and a 46-to 48-hour infusion of fluorouracil on day 1. Patients will also receive celecoxib by mouth once a day on days 1-14 starting on day 1 of course 2. Treatment may repeat every 2 weeks for 12 courses.

Patients in group two will receive a 2-hour infusion of oxaliplatin, a 2-hour infusion of leucovorin calcium, and a 46- to 48-hour infusion of fluorouracil on day 1. Patients will also receive a placebo by mouth once a day on days 1-14 starting on day 1 of course 2. Treatment may repeat every 2 weeks for 12 courses.

Patients in group three will receive a 2-hour infusion of oxaliplatin, a 2-hour infusion of leucovorin calcium, and a 46-to 48-hour infusion of fluorouracil on day 1. Patients will also receive celecoxib by mouth once a day on days 1-14 starting on day 1 of course 2. Treatment may repeat every 2 weeks for 6 courses.

Patients in group four will receive a 2-hour infusion of oxaliplatin, a 2-hour infusion of leucovorin calcium, and a 46- to 48-hour infusion of fluorouracil on day 1. Patients will also receive a placebo by mouth once a day on days 1-14 starting on day 1 of course 2. Treatment may repeat every 2 weeks for 6 courses.

In all groups, treatment with celecoxib or placebo may continue for 3 years.

After finishing treatment, patients will be evaluated every 3 months for 1 year, every 6 months for 2-3, and then once a year for 3 years.

Trial Contact Information

Blanche Reiner RN OCN 610-738-2515
Nona Blauvelt MSN AOCN 610-738-2522

Last Updated: 7/16/2012