Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002662
Status:
COMPLETED
Last Update Posted:
2013-08-02
First Post:
1999-11-01
Brief Title:
Paclitaxel or Docetaxel in Treating Women With Advanced Breast Cancer
Sponsor:
Aventis Pharmaceuticals
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
PHASE III COMPARISON OF TAXOTERE DOCETAXEL AND TAXOL PACLITAXEL IN PATIENTS WITH ADVANCED BREAST CANCER
Status:
COMPLETED
Status Verified Date:
2004-04
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 It is not yet known whether paclitaxel is more effective than docetaxel for breast cancer
PURPOSE Randomized phase III trial to study the effectiveness of paclitaxel or docetaxel in treating women with stage IIIB or metastatic breast cancer
PURPOSE Randomized phase III trial to study the effectiveness of paclitaxel or docetaxel in treating women with stage IIIB or metastatic breast cancer
Detailed Description:
OBJECTIVES
Compare the response rate in women with metastatic or locally advanced inoperable adenocarcinoma of the breast treated with docetaxel vs paclitaxel
Compare the toxicity of these regimens in these patients
Compare the time to disease progression duration of response quality of life and survival of patients treated with these regimens
OUTLINE This is a randomized open-label multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive docetaxel IV over 1 hour on day 1 Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity
Arm II Patients receive paclitaxel IV over 3 hours on day 1 Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline and after courses 4 and 6
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 400 patients 200 per arm will be accrued for this study
Compare the response rate in women with metastatic or locally advanced inoperable adenocarcinoma of the breast treated with docetaxel vs paclitaxel
Compare the toxicity of these regimens in these patients
Compare the time to disease progression duration of response quality of life and survival of patients treated with these regimens
OUTLINE This is a randomized open-label multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive docetaxel IV over 1 hour on day 1 Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity
Arm II Patients receive paclitaxel IV over 3 hours on day 1 Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline and after courses 4 and 6
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 400 patients 200 per arm 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 |
|---|---|---|---|
| NCI-V95-0680 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000064232 | REGISTRY | None | None |
| RP-56976-TAX-311 | None | None | None |