Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005817
Status:
COMPLETED
Last Update Posted:
2013-02-01
First Post:
2000-06-02
Brief Title:
Rebeccamycin Analogue in Treating Women With Stage IIIB or Stage IV Breast Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Phase 2 Study of Rebeccamycin Analog in Advanced Breast Cancer
Status:
COMPLETED
Status Verified Date:
2013-01
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:
Randomized phase II trial to compare the effectiveness of two regimens of rebeccamycin analogue in treating women who have stage IIIB or stage IV breast cancer Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die The best way to give rebeccamycin analog in breast cancer patients is not yet known
Detailed Description:
PRIMARY OBJECTIVES
I To assess the activity of rebeccamycin analog as therapy for advanced breast cancer when administered in two different treatment schedules
SECONDARY OBJECTIVES
I To assess the toxicity associated with administration of rebeccamycin analog therapy in women with advanced breast cancer
II To evaluate topoisomerase I and II levels in human lymphocytes following treatment with rebeccamycin analog
OUTLINE This is a randomized multicenter study Patients are randomized to one of two treatment arms
Arm I Patients receive rebeccamycin analogue IV over 60 minutes on day 1
Arm II Patients receive rebeccamycin analogue IV over 60 minutes on days 1-5
In all arms courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
I To assess the activity of rebeccamycin analog as therapy for advanced breast cancer when administered in two different treatment schedules
SECONDARY OBJECTIVES
I To assess the toxicity associated with administration of rebeccamycin analog therapy in women with advanced breast cancer
II To evaluate topoisomerase I and II levels in human lymphocytes following treatment with rebeccamycin analog
OUTLINE This is a randomized multicenter study Patients are randomized to one of two treatment arms
Arm I Patients receive rebeccamycin analogue IV over 60 minutes on day 1
Arm II Patients receive rebeccamycin analogue IV over 60 minutes on days 1-5
In all arms courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
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 |
|---|---|---|---|
| CDR0000067821 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU01CA062502 |
| 99-283 | None | None | None |
| U01CA062502 | NIH | None | None |