Sulindac and Docetaxel in Treating Women With Metastatic or Recurrent Breast Cancer

Exclusion Criteria

• •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