Celecoxib Combined With Fluorouracil and Leucovorin in Treating Patients With Resected Stage III Adenocarcinoma (Cancer) of the Colon
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|ClinicalTrials.gov Identifier: NCT00085163|
Recruitment Status : Completed
First Posted : June 11, 2004
Last Update Posted : October 20, 2015
RATIONALE: Drugs used in chemotherapy, such as fluorouracil and leucovorin, work in different ways to stop tumor cells from dividing so they stop growing or die. Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. It is not yet known whether fluorouracil and leucovorin are more effective with or without celecoxib in treating resected stage III adenocarcinoma (cancer) of the colon.
PURPOSE: This randomized phase III trial is studying celecoxib, fluorouracil, and leucovorin to see how well they work compared to fluorouracil and leucovorin in treating patients who have undergone surgery for stage III colon cancer.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Drug: celecoxib Drug: fluorouracil Drug: leucovorin calcium Procedure: adjuvant therapy||Phase 3|
- Compare disease-free survival of patients with curatively resected stage III adenocarcinoma of the colon treated with adjuvant fluorouracil and leucovorin calcium with or without celecoxib.
- Compare the overall survival, the occurrence of new primary colon cancer, and the development of new polyps in patients treated with these regimens.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to ≥ 4 tumor-positive lymph nodes (yes vs no), form of adjuvant chemotherapy (infusional vs bolus), low-dose aspirin for cardiovascular prophylaxis (yes vs no), and participating center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive fluorouracil and leucovorin calcium IV for up to 6 courses in the absence of disease recurrence or unacceptable toxicity. Patients also receive oral celecoxib twice daily.
- Arm II: Patients receive oral placebo twice daily and fluorouracil and leucovorin calcium as in arm I.
In both arms, treatment with celecoxib or placebo continues for 3 years in the absence of disease recurrence or unacceptable toxicity.
Patients are followed annually for 2 years.
PROJECTED ACCRUAL: A total of 1,450 patients (725 per treatment arm) will be accrued for this study within 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Multicenter, Double-Blind, Placebo-Controlled Randomized Phase III Study of Adjuvant Therapy With Celecoxib in Combination With Chemotherapy in Patients With Curatively Resected Stage III Colon Cancer|
|Study Start Date :||March 2004|
|Actual Primary Completion Date :||November 2005|
- Disease-free survival as measured by Logrank every 3 months in year 1, every 6 months in years 2-3, and annually thereafter
- Overall survival as measured by Logrank every 3 months in year 1, every 6 months in years 2-3, and annually thereafter
- Time occurrence of new primary colon cancer and new polyps as measured by Logrank every 3 months in year 1, every 6 months in years 2-3, and annually thereafter
- Toxicity as measured by CTC AE version 2.0 every 3 months in year 1, every 6 months in years 2-3, and annually thereafter
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00085163
|Study Chair:||Cornelis J.H. van de Velde, MD, PhD, FRCS, FRCPS||Leiden University Medical Center|
|Study Chair:||Dirk J. Richel, MD, PhD||Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)|
|Study Chair:||Michel Ducreux, MD, PhD||Gustave Roussy, Cancer Campus, Grand Paris|