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

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fox Chase Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Docetaxel; Sulindac

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