A Multicenter Phase III Placebo-Controlled Trial of Celecoxib for Prevention of Capecitabine-Induced Palmar/Plantar (Hand/Foot) Syndrome in Patients With Metastatic Breast and Colorectal Cancer
- Determine the efficacy of celecoxib in reducing the incidence and severity of hand/foot
syndrome caused by capecitabine in patients with metastatic breast cancer or colorectal
OUTLINE: This is a placebo-controlled, randomized, double-blind, multicenter study. Patients
are stratified according to metastatic disease (breast vs colorectal), ECOG performance
status (0 or 1 vs 2), prior chemotherapy (yes vs no).
Patients receive 1 of 2 treatment regimens.
- Regimen A (concurrent radiotherapy): Patients undergo radiotherapy 5 days a week for
5-6 weeks and receive oral capecitabine twice daily 5 days a week. Following completion
of radiotherapy, patients may continue oral capecitabine as in regimen B.
- Regimen B (no radiotherapy): Patients receive oral capecitabine once daily on days
1-14. Courses repeat every 21 days.
Patients are also randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral celecoxib twice daily on days 1-21.
- Arm II: Patients receive oral placebo twice daily on days 1-21. In both arms, treatment
repeats every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 342 patients will be accrued for this study.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
Incidence of hand/foot syndrome (HFS) > grade 1 as assessed by NCI CTC v3.0 criteria at 16 weeks
Interim analysis at 16 Weeks, with evaluations and blood test every 3 weeks.
Scott Kopetz, MD
M.D. Anderson Cancer Center
United States: Federal Government
|CCOP - Kansas City||Kansas City, Missouri 64131|
|CCOP - Kalamazoo||Kalamazoo, Michigan 49007-3731|
|Marshfield Clinic - Marshfield Center||Marshfield, Wisconsin 54449|
|CCOP - Santa Rosa Memorial Hospital||Santa Rosa, California 95403|
|Cancer Research for the Ozarks||Springfield, Missouri 65807|
|CCOP - Columbus||Columbus, Ohio 43206|
|CCOP - Greenville||Greenville, South Carolina 29615|
|CCOP - Grand Rapids||Grand Rapids, Michigan 49503|
|CCOP - Northwest||Tacoma, Washington 98405-0986|
|M. D. Anderson Cancer Center at University of Texas||Houston, Texas 77030-4009|
|CCOP - Main Line Health||Wynnewood, Pennsylvania 19096|
|Scott and White Cancer Institute||Temple, Texas 76508|
|Hematology Oncology Associates of Central New York, PC - Northeast Center||East Syracuse, New York 13057-4510|