NCT00045591

Celecoxib in Treating Women With Metastatic or Recurrent Breast Cancer

Evaluation Of Novel Therapeutic Agents (Celecoxib: NSC # 719627) Against Breast Cancer: An Innovative Randomized Phase II Trial Design

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: Female
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

OBJECTIVES: Primary * Compare the progression-free survival of women with metastatic or recurrent breast cancer treated with 2 dose levels of celecoxib. Secondary * 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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	celecoxib	100 mg PO bid
DRUG	Celecoxib	400 mg PO bid

Timeline

• Start date: 2003-02-01
• Primary completion: 2005-08-01
• Completion: 2010-01-01
• First posted: 2003-01-27
• Last updated: 2017-01-11

Locations

74 sites across 1 country: United States