Ignite Creation Date:
2025-12-24 @ 2:08 PM
Ignite Modification Date:
2025-12-27 @ 7:21 AM
Study NCT ID:
NCT00030095
Status:
COMPLETED
Last Update Posted:
2015-04-30
First Post:
2002-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
2-Methoxyestradiol in Treating Patients With Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077584', 'term': '2-Methoxyestradiol'}], 'ancestors': [{'id': 'D004958', 'term': 'Estradiol'}, {'id': 'D004963', 'term': 'Estrenes'}, {'id': 'D004962', 'term': 'Estranes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D045166', 'term': 'Estradiol Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-09'}, 'statusVerifiedDate': '2006-07', 'lastUpdateSubmitDate': '2015-04-29', 'studyFirstSubmitDate': '2002-01-30', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2015-04-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['unspecified adult solid tumor, protocol specific'], 'conditions': ['Unspecified Adult Solid Tumor, Protocol Specific']}, 'referencesModule': {'references': [{'pmid': '12587805', 'type': 'BACKGROUND', 'citation': 'Lakhani NJ, Sarkar MA, Venitz J, Figg WD. 2-Methoxyestradiol, a promising anticancer agent. Pharmacotherapy. 2003 Feb;23(2):165-72. doi: 10.1592/phco.23.2.165.32088.'}, {'type': 'RESULT', 'citation': 'Lakhani NJ, Sparreboom A, Venitz J, et al.: Single oral dose pharmacokinetics (PK) and safety of 2-methoxyestradiol (2ME2) in patients with solid tumors. [Abstract] J Clin Oncol 23 (Suppl 16): A-2071, 152s, 2005.'}, {'type': 'RESULT', 'citation': 'Dahut WL, Lakhani N, Kohn EC, et al.: A phase I study of 2-methoxyestradiol (2ME2) in patients with solid tumors. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-833, 2003.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: 2-Methoxyestradiol may stop the growth of cancer by stopping blood flow to the tumor.\n\nPURPOSE: Phase I trial to study the effectiveness of 2-methoxyestradiol in treating patients who have advanced solid tumors.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the maximum tolerated dose of 2-methoxyestradiol in patients with advanced solid tumors.\n* Determine the side effect profile of this drug in these patients.\n* Determine the pharmacokinetic profile of this drug in these patients.\n* Determine the changes in positron-emission tomography scans of patients treated with this drug.\n* Determine the changes in apotosis in patients treated with this drug.\n\nOUTLINE: This is a dose-escalation study.\n\nPatients receive oral 2-methoxyestradiol (2ME2) once on day 1 followed by 2 days of evaluation. Patients then receive oral 2ME2 every 12 hours. Treatment continues in the absence of disease progression or unacceptable toxicity.\n\nCohorts of 3-6 patients receive escalating doses of 2ME2 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.\n\nPatients are followed at day 30.\n\nPROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 1 year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed solid tumor\n\n * Metastatic or unresectable disease for which standard curative treatments do not exist or are no longer effective\n* Clinically progressive disease documented by any of the following:\n\n * New area of malignant disease\n * Progression of soft-tissue metastases\n * At least 1 new metastatic deposit on technetium Tc 99m bone scintigraphy\n * Increases in prostate-specific antigen\n* Lesions accessible for serial biopsy\n* No known brain metastases\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nPerformance status:\n\n* ECOG 0-2 OR\n* Karnofsky 60-100%\n\nLife expectancy:\n\n* More than 3 months\n\nHematopoietic:\n\n* WBC at least 3,000/mm\\^3\n* Absolute neutrophil count at least 1,500/mm\\^3\n* Platelet count at least 100,000/mm\\^3\n\nHepatic:\n\n* Bilirubin normal\n* AST/ALT no greater than 2.5 times upper limit of normal\n\nRenal:\n\n* Creatinine normal OR\n* Creatinine clearance at least 60 mL/min\n\nCardiovascular:\n\n* No symptomatic congestive heart failure\n* No unstable angina pectoris\n* No cardiac arrhythmia\n\nOther:\n\n* No other concurrent uncontrolled illness\n* No ongoing or active infection\n* No prior allergic reactions to compounds of similar chemical or biological composition to 2-methoxyestradiol\n* No psychiatric illness or social situation that would preclude study compliance\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception for 1 month before, during, and for 1 month after study participation\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* At least 4 weeks since prior biologic therapy\n\nChemotherapy:\n\n* At least 4 weeks since prior chemotherapy (6 weeks for mitomycin, nitrosoureas, or carboplatin)\n* No concurrent chemotherapy for cancer\n\nEndocrine therapy:\n\n* Luteinizing-hormone releasing-hormone agonist therapy must be continued for patients with prostate cancer except those with prior orchiectomy\n\nRadiotherapy:\n\n* At least 4 weeks since prior radiotherapy\n* No concurrent radiotherapy for cancer\n\nSurgery:\n\n* See Endocrine therapy\n\nOther:\n\n* Recovered from prior therapy\n* No other concurrent therapy for cancer\n* No concurrent combination antiretroviral therapy for HIV-positive patients'}, 'identificationModule': {'nctId': 'NCT00030095', 'briefTitle': '2-Methoxyestradiol in Treating Patients With Advanced Solid Tumors', 'nctIdAliases': ['NCT00024609'], 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Phase I Trial Of 2-Methoxyestradiol (2ME2), (NSC-659853) An Angiogenesis Inhibitor, In Patients With Solid Tumors', 'orgStudyIdInfo': {'id': 'CDR0000069022'}, 'secondaryIdInfos': [{'id': 'NCI-01-C-0256'}, {'id': 'NCI-3371'}, {'id': 'NCI-CC-01-C-0256'}]}, 'armsInterventionsModule': {'interventions': [{'name': '2-methoxyestradiol', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20892-1182', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'NCI - Center for Cancer Research', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}], 'overallOfficials': [{'name': 'William Dahut, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'NCI - Medical Oncology Branch'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}}}}