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

NCT00039520 | Completed Phase 2

• 5 other identifiers: CDR0000069390P30CA006927FCCC-01031FCCC-63723NCI-G02-2080
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

stage IV breast cancer; recurrent breast cancer

Interventions

docetaxel DRUG

sulindac DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Fox Chase Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Docetaxel; Sulindac

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds

Study Officials

• Mary Cianfrocca, DO

  Fox Chase Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2002
• First Posted: January 27, 2003
• Study Start: January 1, 2002
• Primary Completion: June 1, 2004
• Study Completion: July 1, 2008
• Last Updated: May 6, 2014

Record last verified: 2014-05

Locations

US (1)