Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002998
Status:
COMPLETED
Last Update Posted:
2016-07-13
First Post:
1999-11-01
Brief Title:
Gemcitabine and Cisplatin in Treating Patients With Metastatic Breast Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Phase II Study of Gemcitabine GEMZAR and Cisplatin CDDP in Advanced 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 Combining more than one drug may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of gemcitabine and cisplatin in treating patients with metastatic breast cancer that has not responded to systemic therapy
PURPOSE Phase II trial to study the effectiveness of gemcitabine and cisplatin in treating patients with metastatic breast cancer that has not responded to systemic therapy
Detailed Description:
OBJECTIVES I Assess the response rate of gemcitabine and cisplatin in the treatment of metastatic breast cancer in patients who have failed one or two systemic regimens II Determine time to progression and survival in these patients III Define further the toxicity of this two-drug combination in these patients
OUTLINE This is a nonrandomized study Patients receive gemcitabine IV over 30 minutes and cisplatin IV over 1 hour on days 1 8 and 15 every 28 days Patients with complete response may receive an additional 2 courses after attainment of complete response status Treatment continues in the absence of disease progression or unacceptable toxicities for a maximum of 8 courses Patients are followed every 3 months for 2 years and then at 3 years after treatment
OUTLINE This is a nonrandomized study Patients receive gemcitabine IV over 30 minutes and cisplatin IV over 1 hour on days 1 8 and 15 every 28 days Patients with complete response may receive an additional 2 courses after attainment of complete response status Treatment continues in the absence of disease progression or unacceptable toxicities for a maximum of 8 courses Patients are followed every 3 months for 2 years and then at 3 years after treatment
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 |
|---|---|---|---|
| CDR0000065548 | REGISTRY | PDQ Physician Data Query | None |