Expired Study
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Philadelphia, Pennsylvania 19111


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00039520


Primary Contact:

Study Chair
Mary Cianfrocca, DO
Fox Chase Cancer Center


Backup Contact:

N/A


Location Contact:

Philadelphia, Pennsylvania 19111
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 16, 2017

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