Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003351
Status:
COMPLETED
Last Update Posted:
2016-07-14
First Post:
1999-11-01
Brief Title:
Irinotecan in Treating Patients With Refractory Metastatic Breast Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Randomized Phase II Trial of Irinotecan CPT-11 In Patients With Refractory Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2016-07
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Randomized phase II trial to compare the effectiveness of two regimens of irinotecan in treating patients who have refractory metastatic breast cancer
PURPOSE Randomized phase II trial to compare the effectiveness of two regimens of irinotecan in treating patients who have refractory metastatic breast cancer
Detailed Description:
OBJECTIVES I Assess the antitumor activity and toxicity of two different schedules of irinotecan in the treatment of patients with refractory metastatic breast cancer who have received 1 or 2 previous chemotherapy regimens up to one prior therapy for metastatic disease and one for adjuvant therapy II Compare the time to progression survival and quality of life of these patients on these 2 different schedules of irinotecan
OUTLINE This is a randomized study Patients are stratified according to dominant disease visceral vs nonvisceral performance status 0-1 vs 2 and prior chemotherapy in metastatic setting yes vs no Patients assigned to arm I receive irinotecan intravenously over 90 minutes every week for 4 weeks followed by a 2 week rest period Treatment is repeated every 6 weeks in the absence of disease progression or unacceptable toxicity Patients assigned to arm II receive irinotecan intravenously over 90 minutes every 3 weeks for 6 weeks Treatment is repeated every 6 weeks in the absence of disease progression or unacceptable toxicity Quality of life is assessed before and during treatment Patients are followed every 3 months for 2 years then annually for 1 year
PROJECTED ACCRUAL A total of 42-100 patients 21-50 patients per arm will be accrued for this study within 35 years
OUTLINE This is a randomized study Patients are stratified according to dominant disease visceral vs nonvisceral performance status 0-1 vs 2 and prior chemotherapy in metastatic setting yes vs no Patients assigned to arm I receive irinotecan intravenously over 90 minutes every week for 4 weeks followed by a 2 week rest period Treatment is repeated every 6 weeks in the absence of disease progression or unacceptable toxicity Patients assigned to arm II receive irinotecan intravenously over 90 minutes every 3 weeks for 6 weeks Treatment is repeated every 6 weeks in the absence of disease progression or unacceptable toxicity Quality of life is assessed before and during treatment Patients are followed every 3 months for 2 years then annually for 1 year
PROJECTED ACCRUAL A total of 42-100 patients 21-50 patients per arm will be accrued for this study within 35 years
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 |
|---|---|---|---|
| CDR0000066332 | REGISTRY | PDQ Physician Data Query | None |