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

Breast Cancer Clinical Trial

Official title:

A Randomized, Phase II Trial of Weekly Taxol (Paclitaxel) Versus Weekly Taxol Plus Paraplatin (Carboplatin) as First-Line Chemotherapy in Patients Age 65 Years or Older With Metastatic Breast Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00025688
• Other study ID #: CDR0000068992
• Secondary ID: THERADEX-B00-137
• Status: Active, not recruiting
• Phase: Phase 3
• First received: October 11, 2001
• Last updated: July 23, 2008
• Start date: January 2001

Study information

• Verified date: September 2006
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

OBJECTIVES:

• Compare the objective response rate in women treated with paclitaxel with or without carboplatin as first-line chemotherapy for metastatic breast cancer.

• Compare the overall survival, time to disease progression, and duration of response in these patients treated with these regimens.

• Compare the safety of these regimens in this patient population.

• Compare the quality of life of these patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior adjuvant chemotherapy (yes vs no) and ECOG performance status (0-1 vs 2). Patients are randomized to one of two treatment arms.

• Arm I: Patients receive paclitaxel IV over 1 hour weekly for 3 weeks.

• Arm II:Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes weekly for 3 weeks.

Treatment in both arms continues every 4 weeks in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, before each course during study, and then after completion of study.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 220 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• carboplatin

• paclitaxel

Locations

Country	Name	City	State
United States	Clinical Hematology & Oncology Service, Inc.	Akron	Ohio
United States	Maryland Hematology/Oncology Associates	Baltimore	Maryland
United States	MacNeal Cancer Center	Berwyn	Illinois
United States	Center for Hematology and Oncology	Boca Raton	Florida
United States	Finger Lakes Community Cancer Center	Clifton Springs	New York
United States	Northern Virginia Oncology Group, P.C.	Fairfax	Virginia
United States	Texas Cancer Care	Fort Worth	Texas
United States	Cancer Research Network, Inc.	Hollywood	Florida
United States	Oncology Consultants	Houston	Texas
United States	Mayo Clinic	Jacksonville	Florida
United States	East Tennessee Oncology/Hematology, P.C.	Knoxville	Tennessee
United States	St. Barnabas Medical Center	Livingston	New Jersey
United States	Dean Medical Center	Madison	Wisconsin
United States	West Clinic	Memphis	Tennessee
United States	Monterey Bay Oncology	Monterey	California
United States	New Britain General Hospital	New Britain	Connecticut
United States	Oncology Specialists, SC	Park Ridge	Illinois
United States	Wilshire Oncology Medical Group, Inc.	Pomona	California
United States	University of California Davis Cancer Center	Sacramento	California
United States	St. John's Mercy Medical Center	Saint Louis	Missouri
United States	Maine Center for Cancer Medicine and Blood Disorders	Scarborough	Maine
United States	Scranton Hematology-Oncology	Scranton	Pennsylvania
United States	Seattle Cancer Care Alliance	Seattle	Washington
United States	Highlands Oncology Group	Springdale	Arkansas
United States	Scott and White Clinic	Temple	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Theradex

Country where clinical trial is conducted

United States,