Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005963
Status:
COMPLETED
Last Update Posted:
2016-12-07
First Post:
2000-07-05
Brief Title:
Docetaxel and Carboplatin in Treating Women With 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 Docetaxel and Carboplatin as First-Line Therapy for 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 use 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 Phase II trial to study the effectiveness of combining docetaxel and carboplatin in treating women who have metastatic breast cancer
PURPOSE Phase II trial to study the effectiveness of combining docetaxel and carboplatin in treating women who have metastatic breast cancer
Detailed Description:
OBJECTIVES I Determine the anti-tumor activity of docetaxel and carboplatin in women with metastatic adenocarcinoma of the breast II Determine the objective response rate time to progression and survival in patients treated with this regimen III Determine the toxic effects of this regimen in these patients IV Assess the common functional polymorphisms in genes involved in chemotherapeutic response to improve prediction of clinical outcomes and provide insight into the potential for genotype-specific drug dosage
OUTLINE This is a multicenter study Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1 Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity Patients who achieve stable disease SD partial response PR or complete response CR may receive 4 additional courses past SD PR or CR Patients are followed every 6 months for 2 years and then annually for 3 years
OUTLINE This is a multicenter study Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1 Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity Patients who achieve stable disease SD partial response PR or complete response CR may receive 4 additional courses past SD PR or CR Patients are followed every 6 months for 2 years and then annually for 3 years
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-2012-02341 | REGISTRY | CTRP Clinical Trials Reporting System | None |
| CDR0000067945 | REGISTRY | None | None |