Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00070031
Status:
COMPLETED
Last Update Posted:
2013-12-19
First Post:
2003-10-03
Brief Title:
Edotecarin in Treating Women With Locally Advanced or Metastatic Breast Cancer That Has Not Responded to Chemotherapy
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of Intravenous Edotecarin PHA-782615 in Patients With Anthracycline- and Taxane-Refractory or Chemoresistant Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2009-12
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 edotecarin use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE This phase II trial is studying how well edotecarin works in treating women with locally advanced or metastatic breast cancer that has not responded to previous chemotherapy
PURPOSE This phase II trial is studying how well edotecarin works in treating women with locally advanced or metastatic breast cancer that has not responded to previous chemotherapy
Detailed Description:
OBJECTIVES
Primary
Determine the antitumor activity of edotecarin in women with anthracycline- and taxane-refractory or chemoresistant locally advanced or metastatic breast cancer
Secondary
Determine the time to tumor response and duration of response in patients treated with this drug
Determine the overall survival of patients treated with this drug
Determine the clinical benefit of this drug in these patients
Determine the safety and tolerability of this drug in these patients
Determine the pharmacokinetics of this drug in these patients
OUTLINE This is an open-label multicenter study
Patients receive edotecarin IV over 1 hour on day 1 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 2 months until disease progression
PROJECTED ACCRUAL A total of 31-65 patients will be accrued for this study
Primary
Determine the antitumor activity of edotecarin in women with anthracycline- and taxane-refractory or chemoresistant locally advanced or metastatic breast cancer
Secondary
Determine the time to tumor response and duration of response in patients treated with this drug
Determine the overall survival of patients treated with this drug
Determine the clinical benefit of this drug in these patients
Determine the safety and tolerability of this drug in these patients
Determine the pharmacokinetics of this drug in these patients
OUTLINE This is an open-label multicenter study
Patients receive edotecarin IV over 1 hour on day 1 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 2 months until disease progression
PROJECTED ACCRUAL A total of 31-65 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PHARMACIA-EDOABC-4439-001 | None | None | None |
| MSKCC-03056 | None | None | None |