Liposomal Doxorubicin and Gemcitabine in Treating Women With Metastatic Breast Cancer

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pharmatech Oncology
• Treatments: Doxorubicin; Gemcitabine; Liposomal doxorubicin

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