Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Philadelphia, Pennsylvania 19111


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.


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



Primary Contact:

Study Chair
Mary Cianfrocca, DO
Fox Chase Cancer Center

Backup Contact:


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: October 09, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.

Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.