|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Aventis Pharmaceuticals |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002662 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: docetaxel Drug: paclitaxel |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control |
| Official Title: | PHASE III COMPARISON OF TAXOTERE (DOCETAXEL) AND TAXOL (PACLITAXEL) IN PATIENTS WITH ADVANCED BREAST CANCER |
| Study Start Date: | August 1994 |
OBJECTIVES:
OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1 of 2 treatment arms.
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven metastatic or locally advanced, inoperable adenocarcinoma of the breast
Must meet 1 of the following conditions:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
No concurrent corticosteroids except:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Montclair Regional Cancer Center | |
| Birmingham, Alabama, United States, 35213 | |
| United States, Arkansas | |
| Highlands Oncology Group, P.A. - Fayetteville | |
| Fayetteville, Arkansas, United States, 72703 | |
| Northeast Arkansas Clinic | |
| Jonesboro, Arkansas, United States, 72401-3125 | |
| University of Arkansas for Medical Sciences | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| California Cancer Care, Inc. | |
| Greenbrae, California, United States, 94904-2007 | |
| Green Cancer Center at Scripps Clinic | |
| La Jolla, California, United States, 92037 | |
| Sidney Kimmel Cancer Center | |
| San Diego, California, United States, 92121 | |
| United States, Colorado | |
| University of Colorado Cancer Center at University of Colorado Health Sciences Center | |
| Denver, Colorado, United States, 80010 | |
| United States, Connecticut | |
| Norwich Cancer Center | |
| Norwich, Connecticut, United States, 06360 | |
| United States, District of Columbia | |
| George Washington University Medical Center | |
| Washington, District of Columbia, United States, 20037 | |
| United States, Florida | |
| Baptist Regional Cancer Institute - Jacksonville | |
| Jacksonville, Florida, United States, 32207-8554 | |
| United States, Georgia | |
| Georgia Cancer Specialists - DeKalb | |
| Decatur, Georgia, United States, 30033 | |
| United States, Illinois | |
| Rush-Presbyterian-St. Luke's Medical Center | |
| Chicago, Illinois, United States, 60612 | |
| United States, Kentucky | |
| James Graham Brown Cancer Center at University of Louisville | |
| Louisville, Kentucky, United States, 40202 | |
| United States, Maine | |
| Maine Center for Cancer Medicine and Blood Disorders - Scarborough | |
| Scarborough, Maine, United States, 04074 | |
| United States, Massachusetts | |
| Tufts - New England Medical Center | |
| Boston, Massachusetts, United States, 02111 | |
| United States, Michigan | |
| Southfield Oncology Institute, Inc. | |
| Southfield, Michigan, United States, 48076-3779 | |
| University of Michigan Comprehensive Cancer Center | |
| Ann Arbor, Michigan, United States, 48109-0942 | |
| United States, Missouri | |
| Mercy Arch Hematology Oncology, P.C. | |
| Saint Louis, Missouri, United States, 63141 | |
| United States, North Carolina | |
| Blumenthal Cancer Center at Carolinas Medical Center | |
| Charlotte, North Carolina, United States, 28232-2861 | |
| Carolinas Hematology-Oncology Associates | |
| Charlotte, North Carolina, United States, 28203 | |
| United States, Ohio | |
| Charles M. Barrett Cancer Center at University Hospital | |
| Cincinnati, Ohio, United States, 45267-0501 | |
| Cleveland Clinic Taussig Cancer Center | |
| Cleveland, Ohio, United States, 44195 | |
| Hematology Oncology Consultants Inc | |
| Columbus, Ohio, United States, 43235 | |
| United States, Pennsylvania | |
| Oncology-Hematology Associates | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Penn State Cancer Institute at Milton S. Hershey Medical Center | |
| Hershey, Pennsylvania, United States, 17033-0850 | |
| United States, Rhode Island | |
| Roger Williams Medical Center | |
| Providence, Rhode Island, United States, 02908-4735 | |
| United States, South Carolina | |
| Greenville Hospital System | |
| Greenville, South Carolina, United States, 29605 | |
| United States, Tennessee | |
| Baptist Regional Cancer Center - Knoxville | |
| Knoxville, Tennessee, United States, 37901 | |
| United States, Texas | |
| Charles A. Sammons Cancer Center | |
| Dallas, Texas, United States, 75246 | |
| University of Texas Health Science Center at San Antonio | |
| San Antonio, Texas, United States, 78284-7811 | |
| United States, Wisconsin | |
| Medical College of Wisconsin Cancer Center | |
| Milwaukee, Wisconsin, United States, 53226-3596 | |
| Study Chair: | Peter M. Ravdin, MD | University of Texas |
More Information
| Study ID Numbers: | CDR0000064232, AVENTIS-56976-TAX-311, RP-56976-TAX-311, NCI-V95-0680 |
| Study First Received: | November 1, 1999 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00002662 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IV breast cancer stage IIIA breast cancer recurrent breast cancer stage IIIB breast cancer stage IIIC breast cancer |
|
Skin Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Breast Neoplasms Antimitotic Agents Pharmacologic Actions Docetaxel |
Neoplasms Neoplasms by Site Paclitaxel Therapeutic Uses Tubulin Modulators Antineoplastic Agents, Phytogenic Breast Diseases |