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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
Roche Pharma AG |
| Information provided by (Responsible Party): | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00050167 |
Purpose
Primary Objectives:
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: Paclitaxel Drug: Docetaxel Drug: Capecitabine |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Evaluation of Differing Taxanes/Taxane Combinations on the Outcome of Patients With Operable Breast Cancer |
| Enrollment: | 603 |
| Study Start Date: | November 2002 |
| Study Completion Date: | August 2011 |
| Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Weekly Paclitaxel (WP)
Weekly Paclitaxel (WP) for 12 weeks followed by Fluorouracil + Epirubicin + Cyclophosphamide (FEC) every 3 weeks for 4 cycles
|
Drug: Paclitaxel
80 mg/m^2 by vein (IV) Weekly Over 1 Hour x 12 Weeks
Other Name: Taxol
|
|
Experimental: Docetaxel and Capecitabine (DX)
Docetaxel + Capecitabine (DX) days 1-14 every 3 weeks for 4 cycles followed by FEC for 4 cycles.
|
Drug: Docetaxel
75 mg/m^2 by vein (IV) Over 1 Hour Once Every 3 Weeks
Other Name: Taxotere
Drug: Capecitabine
1500 mg/m^2 by mouth Twice Daily x 2 Weeks
Other Name: Xeloda
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Show Detailed Description
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Aman U. Buzdar, MD | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00050167 History of Changes |
| Other Study ID Numbers: | ID01-580 |
| Study First Received: | November 25, 2002 |
| Results First Received: | July 7, 2011 |
| Last Updated: | August 25, 2011 |
| Health Authority: | United States: Food and Drug Administration |
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Breast Cancer Capecitabine Docetaxel Paclitaxel Taxotere |
Taxol Xeloda Taxanes Operable Breast Cancer |
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Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Paclitaxel Docetaxel Taxane Capecitabine Fluorouracil Tubulin Modulators Antimitotic Agents |
Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Antimetabolites, Antineoplastic Antimetabolites Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |