Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00045591
Status:
TERMINATED
Last Update Posted:
2017-01-11
First Post:
2002-09-06
Brief Title:
Celecoxib in Treating Women With Metastatic or Recurrent Breast Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Evaluation Of Novel Therapeutic Agents Celecoxib NSC 719627 Against Breast Cancer An Innovative Randomized Phase II Trial Design
Status:
TERMINATED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 metastaticrecurrent 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 physicians 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
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 metastaticrecurrent 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 physicians 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10CA031946 | NIH | None | None |
| CALGB-40105 | None | None | None |
| CDR0000256905 | REGISTRY | NCI Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |