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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase II Trial Of Exisulind With Docetaxel In Patients With Metastatic Adenocarcinoma Of The Breast

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: docetaxel
* Drug: sulindac


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: docetaxel|nan|
|Drug: sulindac|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV breast cancer, recurrent breast cancer