Paclitaxel With or Without Carboplatin in Treating Women With Metastatic Breast Cancer

NCT00025688 | Unknown Phase 3

• 3 other identifiers: CDR0000068992THERADEX-B00-1370BMS-TAX/MEN.13
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 25

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 if paclitaxel is more effective with or without carboplatin in treating stage IV breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of paclitaxel with or without carboplatin in treating women who have stage IV breast cancer.

Conditions

Breast Cancer

Keywords

stage IV breast cancer; recurrent breast cancer

Interventions

carboplatin DRUG

paclitaxel DRUG

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed breast cancer * Must have clinical evidence of stage IV (M1) disease * HER-2/neu negative (0, 1+, or 2+ by immunohistochemistry or fluorescent in situ hybridization) OR status unknown * At least 1 measurable lesion * At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan * Patients with bone-only disease are not eligible * Ineligible if currently experiencing a complete or partial response to prior hormonal therapy * Patients with disease progression after prior response to hormonal therapy are eligible * Disease progression without prior hormonal therapy is allowed * Stable or asymptomatic brain metastasis allowed if: * Other measurable disease exists * Cranial irradiation completed and brain metastasis stable for at least 4 weeks before study * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 18 and over Sex: * Female Menopausal status: * Pre- or post-menopausal Performance status: * ECOG 0-2 Life expectancy: * At least 3 months Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * AST and ALT no greater than 2 times ULN Renal: * Creatinine no greater than 2 times ULN * Corrected calcium less than 12 mg/dL Cardiovascular: * No New York Heart Association class III or IV heart disease * No documented myocardial infarction within the past 6 months * No congestive heart failure * No unstable angina * No clinically significant pericardial effusion or arrhythmia Other: * No active serious infection * No prior significant allergic reactions to drugs containing Cremophor, such as teniposide, cyclosporine, or vitamin K * No clinically significant (greater than grade 1) peripheral neuropathy * No other serious underlying medical condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy: * More than 6 months since prior adjuvant bone marrow or peripheral blood stem cell transplantation * More than 6 months since prior adjuvant monoclonal antibody therapy * More than 6 months since prior adjuvant vaccine therapy * No prior trastuzumab (Herceptin) * No concurrent anticancer immunotherapy Chemotherapy: * No prior chemotherapy for metastatic breast cancer * More than 6 months since prior adjuvant high-dose chemotherapy * More than 6 months since prior adjuvant taxanes or any other adjuvant chemotherapy * Prior adjuvant taxanes allowed only if administered every 3 weeks Endocrine therapy: * See Disease Characteristics * Any number of prior hormonal therapies for metastatic breast cancer allowed * Patients with definite signs of progression may begin study therapy immediately after stopping hormonal therapy * No concurrent anticancer hormonal agents (including megestrol) Radiotherapy: * At least 3 weeks since prior radiotherapy (4 weeks for cranial irradiation) * No prior radiotherapy to 30% or more of bone marrow * No concurrent radiotherapy except for palliation of painful bone metastasis or pathologic fractures to the area of known lytic disease Surgery: * At least 3 weeks since prior major surgery Other: * More than 6 months since prior neoadjuvant therapy * No other concurrent anticancer drugs

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

Sponsors & Collaborators

• Theradex: lead

Study Sites (25)

Highlands Oncology Group

Springdale, Arkansas, 72764, United States

Location

Monterey Bay Oncology

Monterey, California, 93940, United States

Location

Wilshire Oncology Medical Group, Inc.

Pomona, California, 91767-3021, United States

Location

University of California Davis Cancer Center

Sacramento, California, 95817, United States

Location

New Britain General Hospital

New Britain, Connecticut, 06050, United States

Location

Center for Hematology and Oncology

Boca Raton, Florida, 33486, United States

Location

Cancer Research Network, Inc.

Hollywood, Florida, 33020, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

MacNeal Cancer Center

Berwyn, Illinois, 60402, United States

Location

Oncology Specialists, SC

Park Ridge, Illinois, 60068, United States

Location

Maine Center for Cancer Medicine and Blood Disorders

Scarborough, Maine, 04074, United States

Location

Maryland Hematology/Oncology Associates

Baltimore, Maryland, 21236, United States

Location

St. John's Mercy Medical Center

St Louis, Missouri, 63141, United States

Location

St. Barnabas Medical Center

Livingston, New Jersey, 07039, United States

Location

Finger Lakes Community Cancer Center

Clifton Springs, New York, 14432, United States

Location

Clinical Hematology & Oncology Service, Inc.

Akron, Ohio, 44302, United States

Location

Scranton Hematology-Oncology

Scranton, Pennsylvania, 18510, United States

Location

East Tennessee Oncology/Hematology, P.C.

Knoxville, Tennessee, 37920, United States

Location

West Clinic

Memphis, Tennessee, 38120, United States

Location

Texas Cancer Care

Fort Worth, Texas, 76104, United States

Location

Oncology Consultants

Houston, Texas, 77024, United States

Location

Scott and White Clinic

Temple, Texas, 76508, United States

Location

Northern Virginia Oncology Group, P.C.

Fairfax, Virginia, 22031, United States

Location

Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

Dean Medical Center

Madison, Wisconsin, 53715, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Carboplatin; Paclitaxel

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Edith A. Perez, MD

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 11, 2001
• First Posted: August 5, 2003
• Study Start: January 1, 2001
• Last Updated: July 24, 2008

Record last verified: 2006-09

Locations

US (25)