Clinical trial · Interventional
Sulindac and Docetaxel in Treating Women With Metastatic or Recurrent Breast Cancer
A Phase II Trial Of Exisulind With Docetaxel In Patients With Metastatic Adenocarcinoma Of The Breast
NCT00039520CI-TRIAL-00014425completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.