Liposomal Doxorubicin and Gemcitabine in Treating Women With Metastatic Breast Cancer

Pharmatech Oncology

Overview

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of combining liposomal doxorubicin with gemcitabine in treating women who have metastatic breast cancer.

OBJECTIVES: * Determine the objective response rate in women with metastatic breast cancer treated with doxorubicin HCl liposome and gemcitabine. * Determine the duration of response, time to disease progression, and duration of survival of patients treated with this regimen. * Determine the quality of life of patients treated with this regimen. * Determine the quantitative toxicity of this regimen, in terms of incidence, type, and severity, in these patients. OUTLINE: This is a multicenter study. Patients receive doxorubicin HCl liposome IV over 1 hour on day 1 and gemcitabine IV over 30 minutes on days 1 and 8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 2 courses beyond documentation of CR. Quality of life is assessed at baseline, on day 1 of each course, and then at the end of study. Patients are followed at 4 weeks and then every 3 months for 5 years. PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

Breast Cancer

Interventions

gemcitabine hydrochlorideDRUG

pegylated liposomal doxorubicin hydrochlorideDRUG

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed metastatic breast cancer * Measurable disease * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 18 and over Sex: * Female Menopausal status: * Not specified Performance status: * Karnofsky 60-100% Life expectancy: * At least 3 months Hematopoietic: * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 9 g/dL * Absolute neutrophil count at least 1,500/mm\^3 * No impaired bone marrow function Hepatic: * Bilirubin no greater than 2 mg/dL * AST and ALT no greater than 2 times upper limit of normal (ULN) * Alkaline phosphatase no greater than 2 times ULN (unless attributed to tumor) * No impaired hepatic function Renal: * Creatinine no greater than 2.5 mg/dL OR * Creatinine clearance at least 60 mL/min * No impaired renal function Cardiovascular: * No prior cardiac disease within the past 5 years OR * LVEF at least 50% Other: * No prior uncontrolled seizures * No uncontrolled systemic infection * No anthracycline resistance * No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or 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 trastuzumab (Herceptin) Chemotherapy: * Prior adjuvant therapy with anthracycline of no more than 320 mg/m\^2 allowed Endocrine therapy: * Not specified Radiotherapy: * No prior radiotherapy to more than 1/3 of hematopoietic sites Surgery: * Not specified Other: * At least 30 days since prior investigational medications and recovered * No more than 1 prior treatment regimen for metastatic disease

Locations (6)

Montgomery Cancer Center

Montgomery, Alabama, United States

California Cancer Medical Center

West Covina, California, United States

Pharmatech Oncology

Denver, Colorado, United States

Oncology-Hematology Associates, P.A.

Clinton, Maryland, United States

Data from ClinicalTrials.gov

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