Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00079118
Status:
COMPLETED
Last Update Posted:
2016-12-13
First Post:
2004-03-08
Brief Title:
Irinotecan and Docetaxel 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:
Phase II Trial of Weekly Irinotecan and Docetaxel in Refractory Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2016-12
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 such as irinotecan and docetaxel work in different ways to stop tumor cells from dividing so they stop growing or die Combining more than one chemotherapy drug may kill more tumor cells
PURPOSE This phase II trial is studying how well giving irinotecan together with docetaxel works in treating patients with refractory metastatic breast cancer
PURPOSE This phase II trial is studying how well giving irinotecan together with docetaxel works in treating patients with refractory metastatic breast cancer
Detailed Description:
OBJECTIVES
Primary
Determine the antitumor activity of irinotecan and docetaxel in terms of response rate in patients with refractory metastatic breast cancer
Secondary
Determine the toxicity profile of this regimen in these patients
Determine the progression-free and overall survival of patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive docetaxel IV over 1 hour followed by irinotecan IV over 1 hour on days 1 and 8 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity Patients who achieve a complete response CR receive 2 additional courses beyond CR
Patients are followed every 2 months until disease progression and then every 6 months thereafter
Primary
Determine the antitumor activity of irinotecan and docetaxel in terms of response rate in patients with refractory metastatic breast cancer
Secondary
Determine the toxicity profile of this regimen in these patients
Determine the progression-free and overall survival of patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive docetaxel IV over 1 hour followed by irinotecan IV over 1 hour on days 1 and 8 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity Patients who achieve a complete response CR receive 2 additional courses beyond CR
Patients are followed every 2 months until disease progression and then every 6 months thereafter
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 |
|---|---|---|---|
| CDR0000354417 | REGISTRY | PDQ Physician Data Query | None |
| NCI-2012-02579 | REGISTRY | None | None |