Paclitaxel or Docetaxel in Treating Women With Advanced Breast Cancer

NCT00002662 | Completed Phase 3

• 4 other identifiers: AVENTIS-56976-TAX-311CDR0000064232RP-56976-TAX-311NCI-V95-0680
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 32

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.

Conditions

Breast Cancer

Keywords

stage IV breast cancer; stage IIIA breast cancer; recurrent breast cancer; stage IIIB breast cancer; stage IIIC breast cancer

Interventions

docetaxel DRUG

paclitaxel DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically proven metastatic or locally advanced, inoperable adenocarcinoma of the breast * Clinically evident metastases (e.g., clearly malignant lesions on chest x-ray or CT or abdominal CT do not require histologic confirmation) * Hot spots on bone scan not shown to be malignant on plain x-rays are not adequate evidence of malignant disease in the absence of other lesions * Must meet 1 of the following conditions: * Disease progression after 1 prior chemotherapy regimen for locally advanced or metastatic disease (which may or may not have followed a separate adjuvant regimen using chemotherapy or hormonal therapy) * Locally advanced or metastatic disease during or after 1 adjuvant or neoadjuvant chemotherapy regimen * One of the above chemotherapy regimens must have contained an anthracycline (e.g., doxorubicin, but not mitoxantrone) * Single drug substitution (e.g., methotrexate for doxorubicin) during prior combination chemotherapy allowed * Bidimensionally measurable * No clinical or radiographic evidence of brain or leptomeningeal disease * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 18 and over Sex: * Female Menopausal status: * Not specified Performance status: * Karnofsky 60-100% OR * ECOG 0-2 Life expectancy: * At least 12 weeks Hematopoietic: * Absolute neutrophil count at least 2,000/mm3 * Platelet count at least 100,000/mm3 Hepatic: * Bilirubin normal * SGOT no greater than 2.5 times upper limit of normal Renal: * Creatinine no greater than 2.0 mg/dL * No uncontrolled hypercalcemia Cardiovascular: * No myocardial infarction within the past 6 months * No history of arrhythmia requiring treatment * No heart block * No clinical evidence of congestive heart failure * No unstable angina (e.g., new onset, crescendo, or rest angina) * Stable exertional angina allowed Other: * No current symptomatic grade 2 or greater peripheral neuropathy * No history of hypersensitivity to products containing Cremophor EL (e.g., cyclosporine or teniposide) or Polysorbate 80 (e.g., IV etoposide) * No serious infection * No significant psychiatric disease that would preclude study * No other malignancy within the past 5 years except nonmelanomatous skin cancer or completely excised carcinoma in situ of the cervix * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior bone marrow or stem cell transplantation Chemotherapy: * See Disease Characteristics * At least 3 weeks since prior chemotherapy (2 weeks for oral cyclophosphamide or 6 weeks for nitrosoureas or mitomycin) * No prior high-dose chemotherapy given with ablative intent * No prior taxoids * No other concurrent antineoplastic therapy Endocrine therapy: * See Disease Characteristics * Prior hormonal therapy as adjuvant therapy or for metastatic disease allowed * At least 1 week since prior hormonal therapy * No concurrent corticosteroids except: * Prophylaxis or treatment for acute hypersensitivity reactions * Chronic therapy (more than 6 months) at low doses (20 mg/day or less of methylprednisolone or equivalent) Radiotherapy: * At least 4 weeks since prior radiotherapy to major bone marrow areas * No prior high-dose radiotherapy given with ablative intent * No concurrent radiotherapy except limited palliative radiotherapy (e.g., for a solitary rib fracture) during objective response Surgery: * See Disease Characteristics * More than 2 weeks since prior surgery except simple biopsy or placement of venous access device Other: * At least 4 weeks since prior investigational drugs * Concurrent medications known to alter cardiac conduction (e.g., digoxin, beta blockers, or calcium channel blockers) allowed * No concurrent ketoconazole * No concurrent bisphosphonates unless initiated more than 3 months before randomization * No concurrent experimental drug or therapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Aventis Pharmaceuticals: lead

Study Sites (32)

Montclair Regional Cancer Center

Birmingham, Alabama, 35213, United States

Location

Highlands Oncology Group, P.A. - Fayetteville

Fayetteville, Arkansas, 72703, United States

Location

Northeast Arkansas Clinic

Jonesboro, Arkansas, 72401-3125, United States

Location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

California Cancer Care, Inc.

Greenbrae, California, 94904-2007, United States

Location

Green Cancer Center at Scripps Clinic

La Jolla, California, 92037, United States

Location

Sidney Kimmel Cancer Center

San Diego, California, 92121, United States

Location

University of Colorado Cancer Center at University of Colorado Health Sciences Center

Denver, Colorado, 80010, United States

Location

Norwich Cancer Center

Norwich, Connecticut, 06360, United States

Location

George Washington University Medical Center

Washington D.C., District of Columbia, 20037, United States

Location

Baptist Regional Cancer Institute - Jacksonville

Jacksonville, Florida, 32207-8554, United States

Location

Georgia Cancer Specialists - DeKalb

Decatur, Georgia, 30033, United States

Location

Rush-Presbyterian-St. Luke's Medical Center

Chicago, Illinois, 60612, United States

Location

James Graham Brown Cancer Center at University of Louisville

Louisville, Kentucky, 40202, United States

Location

Maine Center for Cancer Medicine and Blood Disorders - Scarborough

Scarborough, Maine, 04074, United States

Location

Tufts - New England Medical Center

Boston, Massachusetts, 02111, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0942, United States

Location

Southfield Oncology Institute, Inc.

Southfield, Michigan, 48076-3779, United States

Location

Mercy Arch Hematology Oncology, P.C.

St Louis, Missouri, 63141, United States

Location

Carolinas Hematology-Oncology Associates

Charlotte, North Carolina, 28203, United States

Location

Blumenthal Cancer Center at Carolinas Medical Center

Charlotte, North Carolina, 28232-2861, United States

Location

Charles M. Barrett Cancer Center at University Hospital

Cincinnati, Ohio, 45267-0501, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

Hematology Oncology Consultants Inc

Columbus, Ohio, 43235, United States

Location

Penn State Cancer Institute at Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

Location

Oncology-Hematology Associates

Philadelphia, Pennsylvania, 19107, United States

Location

Roger Williams Medical Center

Providence, Rhode Island, 02908-4735, United States

Location

Greenville Hospital System

Greenville, South Carolina, 29605, United States

Location

Baptist Regional Cancer Center - Knoxville

Knoxville, Tennessee, 37901, United States

Location

Charles A. Sammons Cancer Center

Dallas, Texas, 75246, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78284-7811, United States

Location

Medical College of Wisconsin Cancer Center

Milwaukee, Wisconsin, 53226-3596, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Docetaxel; Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Peter M. Ravdin, MD

  The University of Texas Health Science Center at San Antonio

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: August 1, 1994
• Study Completion: June 1, 2004
• Last Updated: August 2, 2013

Record last verified: 2004-04

Locations

US (32)