Liposomal Doxorubicin and Gemcitabine in Treating Women With Metastatic Breast Cancer

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
An Open-Label, Single-Arm, Phase II Study of Liposomal Doxorubicin (Doxil) and Gemcitabine in the Treatment of Women With Metastatic Breast Cancer

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Drug: gemcitabine hydrochloride
* Drug: pegylated liposomal doxorubicin hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: gemcitabine hydrochloride|nan|
|Drug: pegylated liposomal doxorubicin hydrochloride|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stage IV breast cancer