Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-27 @ 10:57 PM
Study NCT ID:
NCT00006260
Status:
COMPLETED
Last Update Posted:
2010-06-11
First Post:
2000-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination Chemotherapy in Treating Patients 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': 'D002945', 'term': 'Cisplatin'}, {'id': 'D005047', 'term': 'Etoposide'}, {'id': 'D007069', 'term': 'Ifosfamide'}, {'id': 'D015080', 'term': 'Mesna'}], 'ancestors': [{'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D011034', 'term': 'Podophyllotoxin'}, {'id': 'D013764', 'term': 'Tetrahydronaphthalenes'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D010078', 'term': 'Oxazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000476', 'term': 'Alkanesulfonates'}, {'id': 'D017738', 'term': 'Alkanesulfonic Acids'}, {'id': 'D000473', 'term': 'Alkanes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D013438', 'term': 'Sulfhydryl Compounds'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D013451', 'term': 'Sulfonic Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1997-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-06', 'lastUpdateSubmitDate': '2010-06-09', 'studyFirstSubmitDate': '2000-09-11', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2010-06-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine the objective response rate in patients with metastatic breast cancer treated with etoposide, ifosfamide with mesna, and cisplatin.', 'timeFrame': 'Treatment continues every 28 days in the absence of unacceptable toxicity or disease progression.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['stage IV breast cancer', 'recurrent breast cancer'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '24028306', 'type': 'DERIVED', 'citation': 'Viana LV, Leitao CB, Grillo MF, Rocha EP, Brenner JK, Friedman R, Gross JL. Hypertension management algorithm for type 2 diabetic patients applied in primary care. Diabetol Metab Syndr. 2013 Sep 12;5(1):52. doi: 10.1186/1758-5996-5-52.'}]}, '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. Drugs such as mesna may be effective in preventing some of the side effects of chemotherapy.\n\nPURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of etoposide and ifosfamide given with mesna, and cisplatin in treating patients who have metastatic breast cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the objective response rate in patients with metastatic breast cancer treated with etoposide, ifosfamide with mesna, and cisplatin.\n* Determine the tolerability and toxicity of this regimen in these patients.\n\nOUTLINE: Patients are stratified according to number of prior chemotherapy courses for metastatic disease (0 vs 1).\n\nPatients receive etoposide IV over 60-90 minutes, cisplatin IV over 30 minutes, and ifosfamide IV over 30 minutes on days 1-3. Mesna is administered IV over 15 minutes 30 minutes prior to and 4 hours after ifosfamide, then orally at 8 hours post infusion. Treatment continues every 28 days in the absence of unacceptable toxicity or disease progression.\n\nPatients are followed every 3 months.\n\nPROJECTED ACCRUAL: At least 36 patients (16 per stratum) will be accrued over 36 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically proven progressive metastatic breast cancer\n* Measurable disease\n\n * Any lesion measurable in 2 dimensions\n * Hepatic metastases if the sum of the measurements below the costal margin in the midclavicular line and the tip to the xiphoid process is greater than 5 cm during quiet respiration\n * Hepatic defects that are clearly measurable by radionuclide, CAT, or MRI scans\n * Bone metastases are not considered measurable disease\n * Evaluable disease allowed if measurable disease also present\n* No brain metastases, carcinomatous meningitis, or spinal cord compression\n* Hormone receptor status:\n\n * Not specified\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* Not specified\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* Hemoglobin at least 10 g/dL\n* WBC at least 4,000/mm3\n* Platelet count at least 100,000/mm3\n\nHepatic:\n\n* Bilirubin no greater than 2.0 mg/dL\n\nRenal:\n\n* Creatinine no greater than 1.5 mg/dL\n* No bladder outlet obstruction\n\nCardiovascular:\n\n* No symptomatic cardiovascular disease (e.g., congestive heart disease) or inability to tolerate a fluid load\n\nOther:\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* No active infection\n* No prior malignancies except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* No greater than 1 prior biologic response modifier treatment for metastatic disease\n\nChemotherapy:\n\n* No greater than 1 prior chemotherapy regimen for metastatic disease allowed\n* Patients who relapsed during or within 6 months after adjuvant chemotherapy are considered to have failed 1 regimen\n* Patients who relapsed more than 6 months after adjuvant chemotherapy are considered to not have had a prior regimen\n* Greater than 4 weeks since prior chemotherapy (greater than 6 weeks for mitomycin or nitrosoureas) and recovered\n* No prior cisplatin, etoposide, or ifosfamide\n\nEndocrine therapy:\n\n* Prior medical or surgical hormonal therapy allowed\n\nRadiotherapy:\n\n* Prior radiation therapy to areas of measurable disease allowed if indicator lesion increased in size by greater than 25% after treatment\n* Recovered from effects of prior radiotherapy\n\nSurgery:\n\n* Recovered from effects of major surgery\n\nOther:\n\n* At least 7 days since prior nephrotoxic drugs (e.g., aminoglycosides, diuretics, lithium, intravenous contrast, or nonsteroidal antiinflammatory drugs)'}, 'identificationModule': {'nctId': 'NCT00006260', 'briefTitle': 'Combination Chemotherapy in Treating Patients With Metastatic Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Case Comprehensive Cancer Center'}, 'officialTitle': 'A Phase II Study Of An OutPatient Three Day VIP Regimen With Oral Mesna For Metastatic Breast Cancer', 'orgStudyIdInfo': {'id': 'CWRU4196'}, 'secondaryIdInfos': [{'id': 'P30CA043703', 'link': 'https://reporter.nih.gov/quickSearch/P30CA043703', 'type': 'NIH'}, {'id': 'CWRU-4196'}, {'id': 'BMS-CRWU-4196'}, {'id': 'NCI-G00-1854'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'cisplatin', 'type': 'DRUG', 'description': 'cisplatin IV over 30 minutes on days 1-3.'}, {'name': 'etoposide', 'type': 'DRUG', 'description': 'etoposide IV over 60-90 minutes on days 1-3.'}, {'name': 'ifosfamide', 'type': 'DRUG', 'description': 'ifosfamide IV over 30 minutes on days 1-3.'}, {'name': 'Mesna', 'type': 'DRUG', 'description': 'Mesna is administered IV over 15 minutes 30 minutes prior to and 4 hours after ifosfamide, then orally at 8 hours post infusion.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '44106-5055', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Scot C. Remick, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Case Comprehensive Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'oldNameTitle': 'Scot C. Remick, MD', 'oldOrganization': 'Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center'}}}}