LY231514 Plus Gemcitabine in Treating Women With Metastatic Breast Cancer

• Status: Completed
• Trial end date: 2008-05-01
• 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. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining LY231514 plus gemcitabine in treating women who have metastatic breast cancer.

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

Details

• Lead Sponsor: Alliance for Clinical Trials in Oncology
• Collaborator: National Cancer Institute (NCI)
• Treatments: Gemcitabine; Pemetrexed

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed breast cancer with clinical evidence of metastatic disease

• Bidimensionally measurable disease

• If bisphosphonates used, must have measurable disease site other than bone

• No bone only disease

• Must have received a prior anthracycline and taxane in the adjuvant and/or metastatic setting

• No clinically significant pericardial effusions, pleural effusions, or ascites unless they can be drained

• No active CNS metastases

• Treated CNS metastasis that has ben stable for at least 8 weeks allowed

• Hormone receptor status:

• Not specified

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Sex:

• Female

Menopausal status:

• Not specified

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 2 times upper limit of normal (ULN)

• AST no greater than 3 times ULN (5 times ULN if liver metastases)

• Albumin at least 3.0 g/dL

Renal:

• Creatinine clearance at least 45 mL/min

Cardiovascular:

• No New York Heart Association class III or IV heart disease

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• Able to take folic acid and cyanocobalamin (vitamin B12) supplements

• Body surface area less than 3 m^2

• No uncontrolled infection

• No chronic debilitating disease

• No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or adequately treated noninvasive carcinomas

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 4 weeks since prior immunotherapy

• At least 4 weeks since prior genetic therapy

• No concurrent immunomodulating agents

Chemotherapy:

• See Disease Characteristics

• No more than 3 prior chemotherapy regimens including adjuvant therapy

• No more than 1 prior chemotherapy regimen for metastatic disease unless these were a taxane and anthracycline

• At least 4 weeks since prior chemotherapy

• No prior gemcitabine and/or pemetrexed disodium

• No other concurrent cytostatic or cytotoxic chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• At least 4 weeks since prior radiotherapy

• No prior radiotherapy to greater than 25% of bone marrow

• No prior strontium chloride Sr 89

• No concurrent radiotherapy

Surgery:

• At least 4 weeks since prior major surgery

Other:

• No aspirin or nonsteroidal antiinflammatory agents 2 days before, the day of, and for 2 days after pemetrexed disodium administration (5 days before for long acting agents such as naproxen, piroxicam, diflunisal, or nabumetone)