Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2025-12-25 @ 6:39 PM
Study NCT ID:
NCT00194766
Status:
COMPLETED
Last Update Posted:
2007-11-14
First Post:
2005-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Continuous Temozolomide in Patients With Advanced or Metastatic Soft Tissue Sarcoma or Metastatic Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D012509', 'term': 'Sarcoma'}], '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'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077204', 'term': 'Temozolomide'}], 'ancestors': [{'id': 'D003606', 'term': 'Dacarbazine'}, {'id': 'D014226', 'term': 'Triazenes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'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': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-11', 'completionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-11-13', 'studyFirstSubmitDate': '2005-09-14', 'studyFirstSubmitQcDate': '2005-09-14', 'lastUpdatePostDateStruct': {'date': '2007-11-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response rate', 'timeFrame': '<= 78 months'}], 'secondaryOutcomes': [{'measure': 'Time to disease progression', 'timeFrame': '<= 78 months'}, {'measure': 'Survival', 'timeFrame': '<= 78 months'}, {'measure': 'To determine the toxicity of the regimen.', 'timeFrame': '<= 78 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Breast cancer', 'Soft tissue sarcoma'], 'conditions': ['Breast Cancer', 'Soft Tissue Sarcoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether treatment with temozolomide can effect the survival of patients with advanced breast cancer or soft tissue sarcoma.', 'detailedDescription': 'Because repeated dosing of temozolomide correlates with an improved response, which may be due to progressive depletion of the enzyme AT, our hope is that a daily oral schedule will be the most active schedule of this agent. In phase I studies doses below 85 mg/m2/day continuously have been well-tolerated. We plan to begin dosing at 75 mg/m2/day for 6 weeks out of an 8 week cycle and to escalate to 85 and 100 mg/m2/day in patients who have no grade 3/4 toxicity.\n\nThe purpose of this study is to determine whether treatment with temozolomide can effect the survival of patients with advanced breast cancer or soft tissue sarcoma. To do this we will assess the response rate, time to progression, and survival in patients with advanced breast cancer or soft tissue sarcoma who are treated with temozolomide.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients must have either:\n\n* Stage IV, microscopically-confirmed carcinoma of the breast with:\n\n * Relapse or progression while receiving, or within 12 months of having received, an anthracycline-containing (doxorubicin or mitoxantrone) or taxane-containing (paclitaxel or docetaxel) regimen as either adjuvant treatment or therapy for advanced breast cancer, or\n * Treatment to a maximum dose of anthracycline (e.g., greater than 450 mg/m2 of doxorubicin), or\n * A dose-limiting toxicity from a taxane, or\n * An ECOG performance status of 2.\n\n * OR -\n* Unresectable or metastatic, microscopically-confirmed soft tissue sarcoma, that is not amenable to treatment with Adriamycin or Ifosfamide due to:\n\n * Poor cardiac reserve, or\n * Poor performance status (ECOG performance status = 2) or\n * Having failed treatment with Adriamycin or reached dose-limiting toxicity from chemotherapy.\n\nPatients must have histologic slides and/or blocks must be available for review.\n\nPatients must have measurable (bidimensionally) or evaluable disease.\n\nPatients must be 18 years old or older.\n\nPatients must have Karnofsky Performance Status greater than 70% (ECOG less than 2) at screen and on the first day of treatment.\n\nPatients must have a life expectancy more than 16 weeks.\n\nPatients must be informed consent must be obtained prior to enrollment.\n\nPatients must be more than 2 weeks from prior surgery; more than 3 weeks from radiation therapy to the pelvis, spine or long bones; more than 3 weeks from prior chemotherapy (more than 6 weeks for mitomycin C or nitrosureas), or more than 2 weeks from prior hormonal therapy.\n\nExclusion Criteria:\n\nGranulocytes less than 1,500/mm3.\n\nPlatelet count less than 100,000/mm3.\n\nHemoglobin less than 10 gm/dl.\n\nCreatinine greater than 2.0 mg/dl.\n\nTotal bilirubin greater than ULN (institutional upper limit of normal).\n\nVisceral crisis characterized by rapidly progressive hepatic or lymphangitic lung metastases (i.e. patients whose disease is beyond control).\n\nMedically unstable (i.e. with uncontrolled disease); diagnosis of other systemic cancer.\n\nPregnancy or lactation; failure to employ adequate contraception.\n\nUncontrolled CNS disease.\n\nGreater than 30% marrow previously irradiated.\n\nPsychological, familial, sociological or geographical conditions which do not permit weekly medical follow-up and compliance with the study protocol.'}, 'identificationModule': {'nctId': 'NCT00194766', 'briefTitle': 'Continuous Temozolomide in Patients With Advanced or Metastatic Soft Tissue Sarcoma or Metastatic Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Continuous Temozolomide (SCH 52365) in Patients With Advanced or Metastatic Soft Tissue Sarcoma or Metastatic Breast Cancer, Phase II', 'orgStudyIdInfo': {'id': '99-1283-A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Temozolomide 75 mg/m2 daily for 6 weeks followed by a two week rest period for a total cycle length of 8 weeks. Treatment is repeated until disease progression, excessive toxicity or other reason to suspend protocol treatment.', 'interventionNames': ['Drug: Temozolomide']}], 'interventions': [{'name': 'Temozolomide', 'type': 'DRUG', 'description': 'Temozolomide 75 mg/m2 daily for 6 weeks followed by a two week rest period for a total cycle length of 8 weeks. Treatment is repeated until disease progression, excessive toxicity or other reason to suspend protocol treatment.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98109-1023', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington/Seattle Cancer Care Alliance', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'James Butrynski, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': 'Schering-Plough', 'class': 'INDUSTRY'}]}}}