Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2025-12-26 @ 3:34 AM
Study NCT ID:
NCT00079118
Status:
COMPLETED
Last Update Posted:
2016-12-13
First Post:
2004-03-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Irinotecan and Docetaxel in Treating Patients With Refractory Metastatic Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D018567', 'term': 'Breast Neoplasms, Male'}], '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': 'D000077146', 'term': 'Irinotecan'}], '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': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-09', 'studyFirstSubmitDate': '2004-03-08', 'studyFirstSubmitQcDate': '2004-03-08', 'lastUpdatePostDateStruct': {'date': '2016-12-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-03-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Confirmed tumor response as measured by RECIST criteria', 'timeFrame': 'Up to 5 years'}], 'secondaryOutcomes': [{'measure': 'Distribution of progression times', 'timeFrame': 'Up to 5 years'}, {'measure': 'Overall survival', 'timeFrame': 'Up to 5 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['stage IV breast cancer', 'recurrent breast cancer', 'male breast cancer'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '19625343', 'type': 'RESULT', 'citation': 'Tan WW, Hillman DW, Salim M, Northfelt DW, Anderson DM, Stella PJ, Niedringhaus R, Bernath AM, Gamini SS, Palmieri F, Perez EA. N0332 phase 2 trial of weekly irinotecan hydrochloride and docetaxel in refractory metastatic breast cancer: a North Central Cancer Treatment Group (NCCTG) Trial. Ann Oncol. 2010 Mar;21(3):493-497. doi: 10.1093/annonc/mdp328. Epub 2009 Jul 22.'}, {'type': 'RESULT', 'citation': 'Tan WW, Hillman D, Salim M, et al.: N0332 phase II trial of weekly irinotecan and docetaxel in refractory metastatic breast cancer: a North Central Cancer Treatment Group trial. [Abstract] Breast Cancer Res Treat 106 (1): A-1087, S71-2, 2007.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy, such as irinotecan and docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells.\n\nPURPOSE: This phase II trial is studying how well giving irinotecan together with docetaxel works in treating patients with refractory metastatic breast cancer.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine the antitumor activity of irinotecan and docetaxel, in terms of response rate, in patients with refractory metastatic breast cancer.\n\nSecondary\n\n* Determine the toxicity profile of this regimen in these patients.\n* Determine the progression-free and overall survival of patients treated with this regimen.\n\nOUTLINE: This is a multicenter study.\n\nPatients receive docetaxel IV over 1 hour followed by irinotecan IV over 1 hour on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 2 additional courses beyond CR.\n\nPatients are followed every 2 months until disease progression and then every 6 months thereafter.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed adenocarcinoma of the breast\n\n * Metastatic disease\n* Previously treated with chemotherapy in the adjuvant setting and/or for metastatic disease\n* At least one unidimensionally measurable lesion\n\n * At least 20 mm by CT scan or MRI OR at least 10 mm by spiral CT scan\n * Superficial clinical lesions (e.g., skin nodules or palpable lymph nodes) are allowed\n * Lesions on chest x-ray are allowed provided they are clearly defined and surrounded by aerated lung\n * The following are not considered measurable:\n\n * Bone lesions\n * Ascites\n * Leptomeningeal disease\n * Pleural/pericardial effusion\n * Inflammatory breast disease\n * Lymphangitis cutis/pulmonis\n * Cystic lesions\n* No known CNS metastases unless controlled by prior surgery and/or radiotherapy\n* Hormone receptor status:\n\n * Estrogen receptor (ER) and/or progesterone receptor (PR) status known\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nSex\n\n* Male or female\n\nMenopausal status\n\n* Not specified\n\nPerformance status\n\n* ECOG 0-2\n\nLife expectancy\n\n* At least 3 months\n\nHematopoietic\n\n* Granulocyte count ≥ 1,500/mm\\^3\n* Hemoglobin ≥ 8.0 g/dL\n* Platelet count ≥ 100,000/mm\\^3\n\nHepatic\n\n* Bilirubin ≤ upper limit of normal (ULN)\n* Meets 1 of the following criteria:\n\n * AST or ALT ≤ ULN AND alkaline phosphatase ≤ 5 times ULN\n * Alkaline phosphatase ≤ ULN AND AST or ALT ≤ 5 times ULN\n * AST or ALT ≤ 1.5 times ULN AND alkaline phosphatase ≤ 2.5 times ULN\n\nRenal\n\n* Creatinine ≤ 1.5 times ULN\n\nCardiovascular\n\n* No myocardial infarction within the past 180 days\n* No congestive heart failure\n* No unstable angina\n* No clinically significant pericardial effusion or arrhythmias\n\nOther\n\n* No active, unresolved infection\n* No prior severe hypersensitivity reaction to docetaxel, irinotecan, or any drug formulated with polysorbate 80\n* No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix\n* No grade 1 or greater sensory or motor neuropathy\n* No other concurrent severe condition that would preclude study participation\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* Prior trastuzumab (Herceptin®) required for HER-2-positive patients (unless contraindicated)\n\nChemotherapy\n\n* See Disease Characteristics\n* More than 14 days since prior chemotherapy\n* No more than 2 prior chemotherapy regimens for metastatic disease\n* No prior irinotecan or docetaxel for metastatic disease\n\n * Docetaxel as adjuvant therapy allowed\n* No other concurrent chemotherapy\n\nEndocrine therapy\n\n* Prior hormonal therapy required for patients with ER- and/or PR-positive tumors (unless contraindicated)\n\nRadiotherapy\n\n* See Disease Characteristics\n* At least 30 days since prior radiotherapy\n* No concurrent radiotherapy\n\nSurgery\n\n* See Disease Characteristics\n* At least 3 weeks since prior major surgery and recovered\n\nOther\n\n* More than 7 days since prior parenteral antibiotic therapy\n* No other concurrent experimental drugs'}, 'identificationModule': {'nctId': 'NCT00079118', 'briefTitle': 'Irinotecan and Docetaxel in Treating Patients With Refractory Metastatic Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Alliance for Clinical Trials in Oncology'}, 'officialTitle': 'Phase II Trial of Weekly Irinotecan and Docetaxel in Refractory Metastatic Breast Cancer', 'orgStudyIdInfo': {'id': 'NCCTG-N0332'}, 'secondaryIdInfos': [{'id': 'NCI-2012-02579', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trials Reporting System)'}, {'id': 'CDR0000354417', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'docetaxel + irinotecan', 'description': 'Patients receive docetaxel IV over 1 hour followed by irinotecan IV over 1 hour on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 2 additional courses beyond CR.\n\nPatients are followed every 2 months until disease progression and then every 6 months thereafter.', 'interventionNames': ['Drug: docetaxel', 'Drug: irinotecan hydrochloride']}], 'interventions': [{'name': 'docetaxel', 'type': 'DRUG', 'armGroupLabels': ['docetaxel + irinotecan']}, {'name': 'irinotecan hydrochloride', 'type': 'DRUG', 'armGroupLabels': ['docetaxel + irinotecan']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85259-5499', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic Scottsdale', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic - Jacksonville', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '60507', 'city': 'Aurora', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush-Copley Cancer Care Center', 'geoPoint': {'lat': 41.76058, 'lon': -88.32007}}, {'zip': '61701', 'city': 'Bloomington', 'state': 'Illinois', 'country': 'United States', 'facility': 'St. Joseph Medical Center', 'geoPoint': {'lat': 40.4842, 'lon': -88.99369}}, {'zip': '61520', 'city': 'Canton', 'state': 'Illinois', 'country': 'United States', 'facility': 'Graham Hospital', 'geoPoint': {'lat': 40.55809, 'lon': -90.03512}}, {'zip': '62321', 'city': 'Carthage', 'state': 'Illinois', 'country': 'United States', 'facility': 'Memorial Hospital', 'geoPoint': {'lat': 40.41643, 'lon': -91.13625}}, {'zip': '61530', 'city': 'Eureka', 'state': 'Illinois', 'country': 'United States', 'facility': 'Eureka Community Hospital', 'geoPoint': {'lat': 40.72143, 'lon': -89.27286}}, {'zip': '61401', 'city': 'Galesburg', 'state': 'Illinois', 'country': 'United States', 'facility': 'Galesburg Clinic', 'geoPoint': {'lat': 40.94782, 'lon': -90.37124}}, {'zip': '61401', 'city': 'Galesburg', 'state': 'Illinois', 'country': 'United States', 'facility': 'Galesburg Cottage Hospital', 'geoPoint': {'lat': 40.94782, 'lon': -90.37124}}, {'zip': '62644', 'city': 'Havana', 'state': 'Illinois', 'country': 'United States', 'facility': 'Mason District Hospital', 'geoPoint': {'lat': 40.30004, 'lon': -90.06095}}, {'zip': '61747', 'city': 'Hopedale', 'state': 'Illinois', 'country': 'United States', 'facility': 'Hopedale Medical Complex', 'geoPoint': {'lat': 40.42087, 'lon': -89.41454}}, {'zip': '60435', 'city': 'Joliet', 'state': 'Illinois', 'country': 'United States', 'facility': 'Joliet Oncology-Hematology Associates, Limited - 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