Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-25 @ 5:36 PM
Study NCT ID:
NCT00001504
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase I Trial of Tamoxifen and 9-Cis-Retinoic Acid in 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': 'D000077556', 'term': 'Alitretinoin'}], 'ancestors': [{'id': 'D014212', 'term': 'Tretinoin'}, {'id': 'D014801', 'term': 'Vitamin A'}, {'id': 'D012176', 'term': 'Retinoids'}, {'id': 'D002338', 'term': 'Carotenoids'}, {'id': 'D011090', 'term': 'Polyenes'}, {'id': 'D000475', 'term': 'Alkenes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D053138', 'term': 'Cyclohexenes'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D010860', 'term': 'Pigments, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1996-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2002-01', 'completionDateStruct': {'date': '2002-01'}, 'lastUpdateSubmitDate': '2008-03-03', 'studyFirstSubmitDate': '1999-11-03', 'studyFirstSubmitQcDate': '1999-11-03', 'lastUpdatePostDateStruct': {'date': '2008-03-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '1999-11-04', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Retinoids', 'Biomarkers'], 'conditions': ['Breast Cancer', 'Breast Neoplasm']}, 'referencesModule': {'references': [{'pmid': '3666278', 'type': 'BACKGROUND', 'citation': 'Fontana JA. Interaction of retinoids and tamoxifen on the inhibition of human mammary carcinoma cell proliferation. Exp Cell Biol. 1987;55(3):136-44. doi: 10.1159/000163409.'}, {'pmid': '6401220', 'type': 'BACKGROUND', 'citation': 'Welsch CW, DeHoog JV. Retinoid feeding, hormone inhibition, and/or immune stimulation and the genesis of carcinogen-induced rat mammary carcinomas. Cancer Res. 1983 Feb;43(2):585-91.'}, {'pmid': '2292243', 'type': 'BACKGROUND', 'citation': 'Jordan VC, Murphy CS. Endocrine pharmacology of antiestrogens as antitumor agents. Endocr Rev. 1990 Nov;11(4):578-610. doi: 10.1210/edrv-11-4-578. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'This is a dosage escalation study to estimate the maximum tolerated dose of 9-cis-retinoic acid given in combination with tamoxifen. Groups of 3 to 6 patients receive oral 9-cis-retinoic acid daily for 4 weeks, after which daily oral tamoxifen is added to the regimen. Patients continue treatment for up to 28 weeks, with tamoxifen continued after the study if medically appropriate.', 'detailedDescription': 'This is a Phase I study of the combination tamoxifen and 9-cis-Retinoic acid in patients with breast cancer. The primary objective of the study is; 1) to determine the maximum tolerated dose of 9-cis-Retinoic acid in combination with Tamoxifen and to determine the overall and dose limiting toxicities. Other objectives are: 2) to determine the effect of Tamoxifen on the pharmacokinetics of 9-cis-Retinoic acid; 3) to evaluate the anti-tumor activity of this combination therapy within the context of a phase I study; 4) and to determine the expression of surrogate biomarkers of breast carcinogenesis before and after treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\nAll patients must have histologically documented diagnosis of Stage III, or IV breast carcinoma.\n\nPatients with stage III that has completed chemotherapy: Estrogen receptor (ER) or progesterone receptor (PR) positive tumor required if premenopausal. Either ER/PR-positive or -negative tumor allowed if postmenopausal and have received prior chemotherapy.\n\nPatients may have stage IV with ER/PR-positive or -negative tumor.\n\nNo CNS metastases, pseudotumor cereri, or seizures.\n\nPRIOR/CONCURRENT THERAPY:\n\nPatients who have ecovered from the toxic effects of prior therapy will be eligible.\n\nPatients with prior tamoxifen will be allowed to participate. At least 3 weeks must have elapsed since the last dose of chemotherapy.\n\nPATIENT CHARACTERISTICS:\n\nAge: 18 and over.\n\nSex: Men and women.\n\nMenopausal status: Any status.\n\nPatients must have a performance status of ECOG 0-2.\n\nPatients must have Hematopoietic criteria of:\n\nANC at least 1,500/mm(3).\n\nPlatelet count at least 90,000/mm(3).\n\nPatients must have Hepatic criteria of:\n\nIn the absence of tumor involvement:\n\nBilirubin no greater than twice normal;\n\nSGOT no greater than twice normal;\n\nAlkaline phosphate no greater than twice normal;\n\nFasting triglycerides less than 3 times normal.\n\nPatients must have Renal criteria of:\n\nSerum creatinine no greater than 1.5 mg/dL OR;\n\nCreatinine clearance at least 60 mL/min.\n\nOther:\n\nNo allergy to study medications.\n\nNo nonmalignant systemic disease that would preclude therapy.\n\nNo second malignancy within 5 years except: Curatively treated basal cell skin carcinoma. Cervical carcinoma in situ.\n\nPregnant women will be excluded.\n\nNegative pregnancy test required within 7 days prior to entry.\n\nAdequate contraception required for 4 weeks prior to, during, and for 1 year after study.\n\nPatients must give informed consent.\n\nPatients who are poor medical or psychiatric risks will be eligible.'}, 'identificationModule': {'nctId': 'NCT00001504', 'briefTitle': 'A Phase I Trial of Tamoxifen and 9-Cis-Retinoic Acid in Breast Cancer Patients', 'organization': {'class': 'NIH', 'fullName': 'National Institutes of Health Clinical Center (CC)'}, 'officialTitle': 'A Phase I Trial of Tamoxifen and 9-Cis-Retinoic Acid in Breast Cancer Patients', 'orgStudyIdInfo': {'id': '960080'}, 'secondaryIdInfos': [{'id': '96-C-0080'}]}, 'armsInterventionsModule': {'interventions': [{'name': '9-cis-Retinoic Acid', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'National Cancer Institute (NCI)', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}}}}