sulindac and docetaxel in treating women with metastatic or recurrent 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 sulindac with docetaxel in treating women who have metastatic or recurrent breast cancer.

objectives: * determine the response rate of women with metastatic or recurrent adenocarcinoma of the breast treated with sulindac and docetaxel. * determine the time to progression of patients treated with this regimen. * determine the toxicity of this regimen in these patients. outline: patients receive oral sulindac twice daily. patients also receive docetaxel iv over 1 hour on day 1. courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. patients are followed within 3-4 weeks. projected accrual: approximately 12-33 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed adenocarcinoma of the breast * metastatic or recurrent disease * measurable disease * bone only disease is not eligible * no hematologic malignancy * no carcinomatous meningitis and/or untreated or uncontrolled brain parenchymal disease * at least 8 weeks since prior therapy for brain parenchymal disease and patient must be asymptomatic from cns disease * hormone receptor status: * not specified patient characteristics: age: * 18 and over sex: * female menopausal status: * premenopausal or postmenopausal performance status: * ecog 0-2 life expectancy: * not specified hematopoietic: * wbc at least 3,000/mm\^3 * absolute neutrophil count at least 1,500/mm\^3 * platelet count at least 100,000/mm\^3 hepatic: * bilirubin no greater than upper limit of normal (uln) * one of the following: * sgot and sgpt no greater than 2.5 times uln and * alkaline phosphatase no greater than uln or * sgot and sgpt no greater than uln and * alkaline phosphatase no greater than 4 times uln renal: * creatinine no greater than 2.0 mg/dl cardiovascular: * no unstable angina * no uncontrolled atrial or ventricular arrhythmias * no congestive heart failure * no uncontrolled hypertension other: * no other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or contralateral breast cancer * no active unresolved infection * no poorly controlled diabetes mellitus * no prior hypersensitivity reactions to sulindac or polysorbate 80 * no peripheral neuropathy grade 2 or greater * no active peptic ulcer disease * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception prior concurrent therapy: biologic therapy: * at least 4 weeks since prior immunotherapy * no concurrent biological response modifiers * no concurrent trastuzumab (herceptin) chemotherapy: * no more than 1 prior chemotherapy regimen in the adjuvant setting * no more than 1 prior chemotherapy regimen for recurrent or metastatic disease * no prior docetaxel * prior paclitaxel allowed * at least 1 week since prior chronic sulindac * at least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) * no other concurrent sulindac * no other concurrent chemotherapy endocrine therapy: * not specified radiotherapy: * at least 4 weeks since prior radiotherapy * no prior radiotherapy to more than 25% of bone marrow * no concurrent radiotherapy surgery: * not specified other: * at least 1 week since prior antibiotics * at least 4 weeks since prior investigational agents * no other concurrent investigational drugs * no other concurrent antineoplastic therapy * no concurrent chronic (full dose for more than 2 weeks) nonsteroidal anti-inflammatory drugs (except ibuprofen or naproxen sodium), including cyclo-oxygenase-2 inhibitors and salicylates (e.g., aspirin, mesalamine, azodisalicylate, salsalate, or sulfasalazine) * no concurrent parenteral antibiotics * concurrent low-dose aspirin for cardiovascular prevention allowed

Keywords: stage iv breast cancer recurrent breast cancer