Ignite Creation Date:
2025-12-24 @ 11:09 PM
Ignite Modification Date:
2025-12-25 @ 8:43 PM
Study NCT ID:
NCT00434369
Status:
UNKNOWN
Last Update Posted:
2008-04-22
First Post:
2007-02-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
5-Fluorouracil Combined With CoFactor (5-10 Methylenetetrahydrofolate) in Treating Advanced Breast Cancer Patients
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': 'C032418', 'term': '5,11-methenyltetrahydrohomofolate'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 31}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-04', 'lastUpdateSubmitDate': '2008-04-18', 'studyFirstSubmitDate': '2007-02-07', 'studyFirstSubmitQcDate': '2007-02-09', 'lastUpdatePostDateStruct': {'date': '2008-04-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-02-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Response Rate'}], 'secondaryOutcomes': [{'measure': 'Progression Free Survival'}, {'measure': 'Overall Survival'}, {'measure': 'Duration of Response'}]}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'A multi-center, open-label, single-arm Phase II trial assessing the efficacy and safety of weekly bolus infusions of 5-fluorouracil combined with CoFactor (5-10 methylenetetrahydrofolate) in advanced breast cancer patients who failed anthracycline and taxane chemotherapy regimens.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent.\n* Women with a histologically/cytologically proven diagnosis of advanced adenocarcinoma of the breast.\n* Measurable disease. At least one unidimensionally measurable non-bony lesion with a diameter \\>=10 mm using spiral CT scans (use of spiral CT must be documented in medical records and used consistently throughout the study) or \\>= 20 mm using conventional CT or MRI scans outside the irradiated area according to RECIST criteria.\n* Patients having failed both prior anthracycline and taxane derivative chemotherapy regimens. Anthrocycline and Taxane failure definitions as defined in the protocol.\n* No more than two prior chemotherapy regimens for advanced disease.\n* Performance status (ECOG) \\<= 2 or Karnofsky \\>= 70\n* Age \\>= 18 years.\n* Life expectancy \\>= 12 weeks.\n* Adequate organ function as shown by the following:\n\n 1. WBCs \\>= 3.0 x 109/L, absolute neutrophil count (ANC)\\>= 1.5 x 109/L, platelets \\>= 100 x 109/L, hemoglobin \\>= 9 g/dL\n 2. Bilirubin \\<= 1.25 x the upper limit of normal (ULN),aspartate aminotransferase(AST or alanine aminotransferase(ALT),= 3 x ULN (or \\<= 5 x ULN in case of liver metastases)\n 3. Serum calcium within normal limits\n 4. Serum albumin within the normal range for the study site\n 5. Creatinine clearance \\>= 60 mL/min (Cockroft and Gault)\n 6. Left ventricular ejection fraction (LVEF) within normal limits as shown by echocardiography or scintigraphy (multiple-gated acquisition scan).\n* Patients of childbearing potential must be using medically acceptable contraception for 4 weeks before start of study treatment and 4 months after study treatment completion. Patients of childbearing potential must have a negative pregnancy test result within 7 days prior to study treatment initiation.\n* Patients with parenchymal brain metastases must be either adequately controlled following resection or completed appropriate radiation therapy and be receiving a stable corticosteroid dose prior to study entry. Patients with leptomeningeal involvement should not be included in the study.\n\nExclusion Criteria:\n\n* Her2/neu positive tumor (2+ or 3+).\n* Pregnancy or lactation\n* Systemic cytotoxic anti-cancer therapy within \\<=4 weeks of study entry, or 6 weeks if the systemic therapy contains a nitrosourea or mitomycin C. Hormonal anti-cancer treatment must be ongoing, or must have been discontinued \\>3 months before study entry.\n* Prior 5-FU- and/or capecitabine-based palliative chemotherapy.\n* Extensive prior radiotherapy affecting more than 30% of bone marrow reserves, or bone marrow / stem cell transplantation.\n* Participation in clinical studies of non-approved experimental agents or procedures within \\<=4 weeks of study entry.\n* History of other malignancy, unless cured and the patient has been disease-free for \\>=2 years. Patients with a history of cervical carcinoma in situ or cured stage I cervical cancer, or of epidermal or basal cell skin cancer, may be eligible for enrollment after discussion with the sponsor.\n* Previous unexpected reaction to fluoropyrimidines, with or without documented deficiency of dihydropyrimidine dehydrogenase, or known hypersensitivity to 5-FU.\n* Psychologic, familial, sociologic or geographic conditions which do not permit compliance with the study protocol and/or study.\n* Significant cardiac disease, including symptomatic ventricular arrhythmia, congestive heart failure, myocardial infarction within 12 months before study entry.\n* Concomitant treatment with any experimental drug or anti-cancer drug, except hormone therapy or bisphosphonates.'}, 'identificationModule': {'nctId': 'NCT00434369', 'briefTitle': '5-Fluorouracil Combined With CoFactor (5-10 Methylenetetrahydrofolate) in Treating Advanced Breast Cancer Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mast Therapeutics, Inc.'}, 'officialTitle': 'A Multi-Center, Open-Label, Single-Arm Phase II Trial Assessing the Efficacy and Safety of Weekly Bolus Infusions of 5-Fluorouracil Combined With CoFactor (5-10 Methylenetetrahydrofolate) in Advanced Breast Cancer Patients Who Failed Anthracycline and Taxane Chemotherapy Regimens', 'orgStudyIdInfo': {'id': '510-08'}}, 'armsInterventionsModule': {'interventions': [{'name': 'CoFactor (ANX-510)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Clinical Research Site in', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Acapulco', 'country': 'Mexico', 'facility': 'Clinical Investigative Site', 'geoPoint': {'lat': 16.11417, 'lon': -91.51028}}, {'city': 'Lima', 'country': 'Peru', 'facility': 'Clinical Investigative Site', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}, {'city': "Kazan'", 'country': 'Russia', 'facility': 'Clinical Research Site in', 'geoPoint': {'lat': 55.78874, 'lon': 49.12214}}, {'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Clinical Investigative Site', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Valencia', 'country': 'Spain', 'facility': 'Clinical Investigative Site', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mast Therapeutics, Inc.', 'class': 'INDUSTRY'}}}}