Celecoxib in Treating Women With Metastatic or Recurrent Breast Cancer

Phase 2

Terminated

• Conditions: Breast Cancer
• Interventions: Drug: Celecoxib

• Registration Number: NCT00045591
• Lead Sponsor: Alliance for Clinical Trials in Oncology

Brief 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.

Study Timeline

• Study First Submitted: 2002-09-06
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Study Start: 2003-02
• Primary Completion: 2005-08
• Study Completion: 2010-01
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-09
• Last Update Posted: 2017-01-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 39

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Celecoxib 100 mg	Celecoxib	-
Celecoxib 400 mg	Celecoxib	-

Primary Outcome Measures

Name	Time	Method
Progression free survival	28 months

Trial Locations

Locations (74)

Northeast Alabama Regional Medical Center; 🇺🇸 Anniston, Alabama, United States

Rebecca and John Moores UCSD Cancer Center; 🇺🇸 La Jolla, California, United States

Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Naval Medical Center - San Diego; 🇺🇸 San Diego, California, United States

Veterans Affairs Medical Center - San Diego; 🇺🇸 San Diego, California, United States

UCSF Comprehensive Cancer Center; 🇺🇸 San Francisco, California, United States

Veterans Affairs Medical Center - San Francisco; 🇺🇸 San Francisco, California, United States

CCOP - Christiana Care Health Services; 🇺🇸 Newark, Delaware, United States

Lombardi Cancer Center at Georgetown University Medical Center; 🇺🇸 Washington, District of Columbia, United States

Walter Reed Army Medical Center; 🇺🇸 Washington, District of Columbia, United States

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