Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-26 @ 2:43 AM
Study NCT ID:
NCT00009802
Status:
COMPLETED
Last Update Posted:
2013-12-19
First Post:
2001-02-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Calcitriol Plus Paclitaxel in Treating Patients With Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002117', 'term': 'Calcitriol'}, {'id': 'D017239', 'term': 'Paclitaxel'}], 'ancestors': [{'id': 'D004100', 'term': 'Dihydroxycholecalciferols'}, {'id': 'D006887', 'term': 'Hydroxycholecalciferols'}, {'id': 'D002762', 'term': 'Cholecalciferol'}, {'id': 'D002782', 'term': 'Cholestenes'}, {'id': 'D002776', 'term': 'Cholestanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013261', 'term': 'Sterols'}, {'id': 'D014807', 'term': 'Vitamin D'}, {'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2005-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-18', 'studyFirstSubmitDate': '2001-02-02', 'studyFirstSubmitQcDate': '2003-06-05', 'lastUpdatePostDateStruct': {'date': '2013-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-06-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-06', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['unspecified adult solid tumor, protocol specific'], 'conditions': ['Unspecified Adult Solid Tumor, Protocol Specific']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Calcitriol may increase the effectiveness of paclitaxel by making tumor cells more sensitive to the drug.\n\nPURPOSE: Phase I trial to study the effectiveness of combining calcitriol with paclitaxel in treating patients who have advanced solid tumors.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the toxic effects and maximum tolerated dose of calcitriol when combined with paclitaxel in patients with advanced solid tumors.\n* Determine the effect of administration of calcitriol on the pharmacokinetics of paclitaxel in these patients.\n* Determine the effect of administration of paclitaxel on the pharmacokinetics of calcitriol in these patients.\n\nOUTLINE: This is a dose-escalation study of calcitriol.\n\nDuring course 1, patients receive oral calcitriol daily on days 1-3 of weeks 1-6 and paclitaxel IV over 1 hour on day 1 of week 1 and day 3 of weeks 2-6. During course 2 and subsequent courses, patients receive oral calcitriol daily on days 1-3 and paclitaxel IV over 1 hour on day 3 of weeks 1-6. Treatment continues every 8 weeks in the absence of disease progression or unacceptable toxicity.\n\nCohorts of 3-6 patients receive escalating doses of calcitriol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the highest dose giving an estimated probability of dose-limiting toxicity of no more than 0.30.\n\nPROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically proven advanced cancer not curable by standard therapies\n* Brain metastases allowed following definitive radiotherapy\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nPerformance status:\n\n* ECOG 0-2\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* Absolute neutrophil count at least 1,500/mm\\^3\n* Platelet count at least 100,000/mm\\^3\n\nHepatic:\n\n* Bilirubin no greater than 1.5 mg/dL\n* SGOT no greater than 4 times normal\n\nRenal:\n\n* Creatinine no greater than 2.0 mg/dL\n* Calcium no greater than 10.5 mg/dL\n\nOther:\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective double-barrier contraception for at least 1 week before, during, and for at least 2 weeks after study\n* No active infection or serious concurrent condition\n* No symptomatic peripheral neuropathy greater than grade 1\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* At least 3 weeks since prior regional or systemic biologic therapy\n\nChemotherapy:\n\n* At least 3 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosourea)\n\nEndocrine therapy:\n\n* Not specified\n\nRadiotherapy:\n\n* See Disease Characteristics\n* At least 3 weeks since prior radiotherapy\n\nSurgery:\n\n* Not specified'}, 'identificationModule': {'nctId': 'NCT00009802', 'briefTitle': 'Calcitriol Plus Paclitaxel in Treating Patients With Advanced Solid Tumors', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'A Phase I Trial Of Oral Calcitriol [1,25-(OH)2D3] And Paclitaxel In Advanced Solid Tumors', 'orgStudyIdInfo': {'id': '98-019'}, 'secondaryIdInfos': [{'id': 'CDR0000068411', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}, {'id': 'PCI-IRB-980542'}, {'id': 'NCI-G00-1901'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'calcitriol', 'type': 'DIETARY_SUPPLEMENT'}, {'name': 'paclitaxel', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213-3489', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Cancer Institute', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Ramesh K. Ramanathan, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Pittsburgh'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Research Manager', 'investigatorFullName': 'Laura A. Pollice', 'investigatorAffiliation': 'University of Pittsburgh'}}}}