Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2026-02-24 @ 3:15 PM
Study NCT ID:
NCT00039520
Status:
COMPLETED
Last Update Posted:
2014-05-06
First Post:
2002-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sulindac and Docetaxel in Treating Women With Metastatic or Recurrent Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077143', 'term': 'Docetaxel'}, {'id': 'D013467', 'term': 'Sulindac'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D007192', 'term': 'Indenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-05', 'studyFirstSubmitDate': '2002-06-06', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2014-05-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-06', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['stage IV breast cancer', 'recurrent breast cancer'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': '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.\n\nPURPOSE: Phase II trial to study the effectiveness of combining sulindac with docetaxel in treating women who have metastatic or recurrent breast cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the response rate of women with metastatic or recurrent adenocarcinoma of the breast treated with sulindac and docetaxel.\n* Determine the time to progression of patients treated with this regimen.\n* Determine the toxicity of this regimen in these patients.\n\nOUTLINE: 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.\n\nPatients are followed within 3-4 weeks.\n\nPROJECTED ACCRUAL: Approximately 12-33 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed adenocarcinoma of the breast\n\n * Metastatic or recurrent disease\n* Measurable disease\n\n * Bone only disease is not eligible\n* No hematologic malignancy\n* No carcinomatous meningitis and/or untreated or uncontrolled brain parenchymal disease\n\n * At least 8 weeks since prior therapy for brain parenchymal disease and patient must be asymptomatic from CNS disease\n* Hormone receptor status:\n\n * Not specified\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nSex:\n\n* Female\n\nMenopausal status:\n\n* Premenopausal or postmenopausal\n\nPerformance status:\n\n* ECOG 0-2\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* WBC at least 3,000/mm\\^3\n* Absolute neutrophil count at least 1,500/mm\\^3\n* Platelet count at least 100,000/mm\\^3\n\nHepatic:\n\n* Bilirubin no greater than upper limit of normal (ULN)\n* One of the following:\n\n * SGOT and SGPT no greater than 2.5 times ULN AND\n * Alkaline phosphatase no greater than ULN OR\n * SGOT and SGPT no greater than ULN AND\n * Alkaline phosphatase no greater than 4 times ULN\n\nRenal:\n\n* Creatinine no greater than 2.0 mg/dL\n\nCardiovascular:\n\n* No unstable angina\n* No uncontrolled atrial or ventricular arrhythmias\n* No congestive heart failure\n* No uncontrolled hypertension\n\nOther:\n\n* 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\n* No active unresolved infection\n* No poorly controlled diabetes mellitus\n* No prior hypersensitivity reactions to sulindac or Polysorbate 80\n* No peripheral neuropathy grade 2 or greater\n* No active peptic ulcer disease\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* At least 4 weeks since prior immunotherapy\n* No concurrent biological response modifiers\n* No concurrent trastuzumab (Herceptin)\n\nChemotherapy:\n\n* No more than 1 prior chemotherapy regimen in the adjuvant setting\n* No more than 1 prior chemotherapy regimen for recurrent or metastatic disease\n* No prior docetaxel\n* Prior paclitaxel allowed\n* At least 1 week since prior chronic sulindac\n* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)\n* No other concurrent sulindac\n* No other concurrent chemotherapy\n\nEndocrine therapy:\n\n* Not specified\n\nRadiotherapy:\n\n* At least 4 weeks since prior radiotherapy\n* No prior radiotherapy to more than 25% of bone marrow\n* No concurrent radiotherapy\n\nSurgery:\n\n* Not specified\n\nOther:\n\n* At least 1 week since prior antibiotics\n* At least 4 weeks since prior investigational agents\n* No other concurrent investigational drugs\n* No other concurrent antineoplastic therapy\n* 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)\n* No concurrent parenteral antibiotics\n* Concurrent low-dose aspirin for cardiovascular prevention allowed'}, 'identificationModule': {'nctId': 'NCT00039520', 'briefTitle': 'Sulindac and Docetaxel in Treating Women With Metastatic or Recurrent Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Fox Chase Cancer Center'}, 'officialTitle': 'A Phase II Trial Of Exisulind With Docetaxel In Patients With Metastatic Adenocarcinoma Of The Breast', 'orgStudyIdInfo': {'id': 'CDR0000069390'}, 'secondaryIdInfos': [{'id': 'P30CA006927', 'link': 'https://reporter.nih.gov/quickSearch/P30CA006927', 'type': 'NIH'}, {'id': 'FCCC-01031'}, {'id': 'FCCC-63723'}, {'id': 'NCI-G02-2080'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'docetaxel', 'type': 'DRUG'}, {'name': 'sulindac', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '19111', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Fox Chase Cancer Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Mary Cianfrocca, DO', 'role': 'STUDY_CHAIR', 'affiliation': 'Fox Chase Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fox Chase Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}