Gemcitabine in Treating Women With Metastatic Breast Cancer Previously Treated With Doxorubicin and Paclitaxel

• Status: Completed
• Trial end date: 2002-11-01
• 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 gemcitabine in treating women with metastatic breast cancer previously treated with doxorubicin and paclitaxel.

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

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Gemcitabine

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed metastatic breast cancer

• Bidimensionally measurable disease

• No bone scan abnormalities alone

• Lytic lesions in conjunction with bone scan abnormalities allowed

• No pure blastic bone metastases

• No pleural or peritoneal effusions

• No previously irradiated lesions

• Must have received 2-4 prior chemotherapy regimens, including paclitaxel and doxorubicin, for breast cancer

• Brain metastases allowed if other measurable disease exists

• No uncontrolled or life threatening brain lesions

• No carcinomatous meningitis

• Hormone receptor status:

• Not specified

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Sex:

• Female

Menopausal status:

• Not specified

Performance status:

• Karnofsky 60-100%

Life expectancy:

• Not specified

Hematopoietic:

• Granulocyte count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

Hepatic:

• AST/ALT no greater than 5 times upper limit of normal

Renal:

• Calcium no greater than 11.0 mg/dL

Other:

• Not pregnant

• Negative pregnancy test

• No history of other malignancy except carcinoma in situ of the cervix or curatively treated nonmelanoma skin cancer

• No other serious medical illnesses, including severe infection and severe malnutrition

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• See Disease Characteristics

• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin) and recovered

• No other concurrent chemotherapy

Endocrine therapy:

• Prior hormonal therapies for stage IV disease and/or adjuvant therapy allowed

• At least 3 weeks since prior hormonal therapy

Radiotherapy:

• See Disease Characteristics

• No prior radiotherapy to greater than 30% of the marrow bearing bone

• At least 4 weeks since prior radiotherapy and recovered

• No concurrent radiotherapy to the only measurable lesion

Surgery:

• Recovered from prior surgery

• No concurrent surgery to the only measurable lesion

Other:

• No concurrent nonprotocol treatment