Celecoxib in Treating Women With Metastatic or Recurrent Breast Cancer
RATIONALE: Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for their growth and by stopping blood flow to the tumor. It is not yet known which regimen of celecoxib is more effective in treating breast cancer.
PURPOSE: Randomized phase II trial to compare the effectiveness of two regimens of celecoxib in treating women who have metastatic or recurrent breast cancer
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Evaluation Of Novel Therapeutic Agents (Celecoxib: NSC # 719627) Against Breast Cancer: An Innovative Randomized Phase II Trial Design|
- Progression free survival [ Time Frame: 28 months ] [ Designated as safety issue: No ]
|Study Start Date:||February 2003|
|Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
|Experimental: Celecoxib 100 mg||
100 mg PO bid
|Experimental: Celecoxib 400 mg||
400 mg PO bid
- Compare the progression-free survival of women with metastatic or recurrent breast cancer treated with 2 dose levels of celecoxib.
- Compare the side effects of the 2 dose levels of this drug in these patients.
- Compare the overall survival of patients treated with the 2 dose levels of this drug.
OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to disease status at study entry (complete response vs partial response vs stable) and prior metastatic/recurrent chemotherapy regimens (1 vs 2). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral high-dose celecoxib twice daily.
- Arm II: Patients receive oral low-dose celecoxib twice daily. In both arms, treatment continues until first disease progression. At disease progression, treatment assignment is unblinded and treatment may continue at the treating physician's discretion. Patients initially randomized to the low-dose arm may either continue on that dosage or crossover to the high-dose arm. Patients initially randomized to the high-dose arm may continue on that dosage. Treatment after disease progression may continue for up to 12 months.
Patients are followed every 3 months for 1 year and then every 6 months for up to 4 years.
PROJECTED ACCRUAL: A total of 132 patients (88 in the high-dose arm and 44 in the low-dose arm) will be accrued for this study within 22 months.
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|Study Chair:||Charles L. Shapiro, MD||Ohio State University Comprehensive Cancer Center|