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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00008411 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Randomized phase III trial to determine the effectiveness of docetaxel in treating patients who have metastatic breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: Docetaxel |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase III Study Comparing the Use of Docetaxel on a Every Three-Week vs. Weekly Schedule in the Treatment of Patients With Metastatic Breast Cancer |
| Enrollment: | 90 |
| Study Start Date: | December 1999 |
| Study Completion Date: | January 2007 |
| Primary Completion Date: | March 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Docetaxel Weekly
Arm I: Docetaxel IV over 1 hour on day 1. Courses repeat every 21 days.
|
Drug: Docetaxel
35 mg/m2 IV over 30 minutes on days 1, 8, and 15, for 3 weeks followed by one week of rest repeated every 28 days.
Other Name: Taxotere
|
|
Experimental: Docetaxel Every 3 Weeks
Arm II: Docetaxel IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days.
|
Drug: Docetaxel
Every 3 weeks at a starting dose of 75 mg/m2 IV over 1 hour on day 1, repeated every 21 days.
Other Name: Taxotere
|
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior taxane use (yes vs no), number of prior chemotherapy regimens for metastatic disease (0 vs 1), and participating center. Patients are randomized to one of two treatment arms.
Treatment continues in both arms in the absence of disease progression or unacceptable toxicity.
Patients are followed at 3 weeks, at 3, 6, 9, and 12 months, and then annually for 4 years.
PROJECTED ACCRUAL: A total of 160 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Neurologic:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations| United States, Texas | |
| MD Anderson Cancer Center at University of Texas | |
| Houston, Texas, United States, 77030-4009 | |
| University of Texas M.D. Anderson CCOP Research Base | |
| Houston, Texas, United States, 77030-4009 | |
| Study Chair: | Edgardo Rivera, MD | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | Stacy Moulder M.D., UT MD Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00008411 History of Changes |
| Other Study ID Numbers: | ID99-242, P30CA016672, MDA-ID-99242, AVENTIS-MDA-ID-99242, NCI-1691, CDR0000068408 |
| Study First Received: | January 6, 2001 |
| Last Updated: | August 2, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
stage IV breast cancer recurrent breast cancer |
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
Docetaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |