Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2025-12-25 @ 11:26 PM
Study NCT ID:
NCT00025493
Status:
TERMINATED
Last Update Posted:
2013-01-24
First Post:
2001-10-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
S0029 Docetaxel in Treating Older Women With Metastatic 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'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'whyStopped': 'poor accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2001-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-22', 'studyFirstSubmitDate': '2001-10-11', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2013-01-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Study treatment feasibility', 'timeFrame': 'monthly for duration of accrual'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'at weeks 10 and 19, then every 3 months for 3 years'}, {'measure': 'Survival at 2 years', 'timeFrame': 'at weeks 10 and 19, then every 3 months for 2 years'}, {'measure': 'Response rate (confirmed and unconfirmed complete and partial response)', 'timeFrame': 'at weeks 10 and 19, then every 3 months for 3 years'}, {'measure': 'Toxicity and tolerability', 'timeFrame': 'at week 1, then every 3 weeks'}, {'measure': 'Feasibility of standardized self-report measures of comorbidity, depression, and functional status', 'timeFrame': 'upon completion of patient accrual'}, {'measure': 'Comparison of clinical pharmacologic parameters between elderly patients and patients under 60 years of age', 'timeFrame': 'upon completion of patient accrual'}]}, 'oversightModule': {'oversightHasDmc': True}, '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.\n\nPURPOSE: Phase II trial to study the effectiveness of docetaxel in treating older women who have metastatic breast cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the feasibility of treating elderly women with metastatic breast cancer with docetaxel.\n* Determine the overall survival, 2-year survival, and response (confirmed and unconfirmed complete and partial) in patients treated with this drug.\n* Determine the toxicity and tolerability of this drug in these patients.\n* Determine the feasibility of using standardized self-report measures of comorbidity, depression, and functional status in elderly cancer patients.\n* Determine the parameters of clinical pharmacology of this drug in elderly patients and in patients under 60 years of age.\n* Determine, preliminarily, the genetic polymorphisms and gene expression levels of enzymes involved in drug metabolism and resistance in patients treated with this drug.\n\nOUTLINE: Patients are stratified according to age (70 and over vs under 60).\n\nPatients receive docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.\n\nPatients are followed every 3 months for 3 years.\n\nPROJECTED ACCRUAL: Approximately 80 patients (60 patients age 70 and over and 20 patients under age 60) will be accrued for this study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed breast cancer\n\n * Distant metastatic disease confirmed by histology, cytology, or strong clinical evidence\n* Measurable disease\n* No known brain or CNS metastases\n* Hormone receptor status:\n\n * Not specified\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 70 and over OR\n* Under 60\n\nSex:\n\n* Female\n\nMenopausal status:\n\n* Not specified\n\nPerformance status:\n\n* Zubrod 0-2\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* Absolute granulocyte count at least 1,500/mm\\^3\n* Hemoglobin at least 9 g/dL\n* Platelet count at least 100,000/mm\\^3\n\nHepatic:\n\n* Bilirubin no greater than upper limit of normal (ULN)\n* SGOT or SGPT no greater than 1.5 times ULN (2.0 times ULN if liver metastases are present)\n* Alkaline phosphatase no greater than 1.5 times ULN (2.0 times ULN if liver metastases are present)\n\nRenal:\n\n* Creatinine no greater than ULN\n\nOther:\n\n* Not pregnant or nursing\n* Fertile patients must use effective contraception\n* HIV negative\n* No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* No concurrent immunotherapy for breast cancer\n\nChemotherapy:\n\n* Prior adjuvant or neoadjuvant chemotherapy allowed\n* Prior adjuvant taxanes allowed\n* No other concurrent chemotherapy for breast cancer\n\nEndocrine therapy:\n\n* Prior hormonal therapy in the adjuvant setting or for metastatic disease allowed\n* No concurrent hormonal therapy for breast cancer\n\nRadiotherapy:\n\n* No concurrent radiotherapy for breast cancer\n\nSurgery:\n\n* Not specified\n\nOther\n\n* No more than 1 prior regimen for advanced, recurrent, or metastatic disease'}, 'identificationModule': {'nctId': 'NCT00025493', 'briefTitle': 'S0029 Docetaxel in Treating Older Women With Metastatic Breast Cancer', 'organization': {'class': 'NETWORK', 'fullName': 'SWOG Cancer Research Network'}, 'officialTitle': 'Single Agent Docetaxel for Metastatic Breast Cancer in Patients Aged 70 Years and Older (and in a Cohort of Patients Younger Than 60 Years)', 'orgStudyIdInfo': {'id': 'CDR0000068966'}, 'secondaryIdInfos': [{'id': 'U10CA032102', 'link': 'https://reporter.nih.gov/quickSearch/U10CA032102', 'type': 'NIH'}, {'id': 'S0029', 'type': 'OTHER', 'domain': 'SWOG'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'docetaxel', 'description': 'docetaxel', 'interventionNames': ['Drug: docetaxel']}], 'interventions': [{'name': 'docetaxel', 'type': 'DRUG', 'armGroupLabels': ['docetaxel']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Silvana Martino, DO', 'role': 'STUDY_CHAIR', 'affiliation': "Saint John's Cancer Institute"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SWOG Cancer Research Network', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}