ly231514 plus gemcitabine in treating women with metastatic breast cancer

Conditions: Breast Cancer

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.

objectives: * assess the antitumor activity of pemetrexed disodium in combination with gemcitabine in the treatment of women with metastatic breast cancer who have received an anthracycline and a taxane in the adjuvant and/or metastatic setting and no more than 1 chemotherapy regimen for metastatic disease (unless these were a taxane and anthracycline). * determine the toxicity of this regimen in this patient population. * determine time to progression and overall survival of these patients receiving this regimen. outline: patients receive gemcitabine iv over 30 minutes on days 1 and 8. pemetrexed disodium iv is administered over 10 minutes 90 minutes following gemcitabine on day 8. treatment continues every 21 days for a minimum of 6 courses in the absence of unacceptable toxicity or disease progression. patients achieving a complete response receive 2 additional courses. patients are followed every 3 months for 5 years. projected accrual: a total of 60 patients will be accrued for this study within 1 year.

Eligibility 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)

Keywords: stage iv breast cancer recurrent breast cancer