Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004182
Status:
COMPLETED
Last Update Posted:
2012-06-06
First Post:
2000-01-21
Brief Title:
Irinotecan in Treating Patients With Metastatic or Recurrent Breast Cancer
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Phase II Study for the Evaluation of CPT-11 Irinotecan Camptosar in Patients With Metastatic or Recurrent Breast Cancer
Status:
COMPLETED
Status Verified Date:
2012-05
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 Phase II trial to study the effectiveness of irinotecan in treating patients who have metastatic or recurrent breast cancer
PURPOSE Phase II trial to study the effectiveness of irinotecan in treating patients who have metastatic or recurrent breast cancer
Detailed Description:
OBJECTIVES I Determine the objective response rate to irinotecan in patients with metastatic breast cancer who have received prior anthracycline and taxane based chemotherapy for metastatic disease II Determine the toxicities of irinotecan in these patients III Determine survival time duration of response and time to treatment failure in these patients after this therapy
OUTLINE Patients receive irinotecan IV over 90 minutes weekly for 4 weeks Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity Patients are followed at day 30 then every 3 months
PROJECTED ACCRUAL A total of 14-29 patients will be accrued for this study
OUTLINE Patients receive irinotecan IV over 90 minutes weekly for 4 weeks Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity Patients are followed at day 30 then every 3 months
PROJECTED ACCRUAL A total of 14-29 patients will be accrued for this study
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 |
|---|---|---|---|
| NCI-G99-1642 | None | None | None |
| NU-98B3 | None | None | None |
| P-UPJOHN-976475150 | None | None | None |