Ignite Creation Date:
2025-12-24 @ 9:37 PM
Ignite Modification Date:
2025-12-28 @ 11:19 PM
Study NCT ID:
NCT00009932
Status:
UNKNOWN
Last Update Posted:
2013-05-15
First Post:
2001-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination Chemotherapy in Treating Patients With Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D017313', 'term': 'Fenretinide'}, {'id': 'D017239', 'term': 'Paclitaxel'}], 'ancestors': [{'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'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': 'D010860', 'term': 'Pigments, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D004224', 'term': 'Diterpenes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2001-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2002-10', 'lastUpdateSubmitDate': '2013-05-14', 'studyFirstSubmitDate': '2001-02-02', 'studyFirstSubmitQcDate': '2003-06-05', 'lastUpdatePostDateStruct': {'date': '2013-05-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-06-06', 'type': 'ESTIMATED'}}, '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. Combining more than one drug may kill more tumor cells.\n\nPURPOSE: Phase I trial to study the effectiveness of combining fenretinide, paclitaxel, and cisplatin in treating patients who have solid tumors that have not responded to previous therapy.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the maximum tolerated dose, clinical toxicity, and recommended phase II dose of fenretinide when combined with paclitaxel and cisplatin in patients with refractory solid tumors.\n* Determine the pharmacokinetics of this regimen in these patients.\n* Determine the therapeutic response to this regimen in these patients.\n\nOUTLINE: This is a dose escalation, multicenter study of fenretinide.\n\nPatients receive oral fenretinide twice daily on days 1-7 and paclitaxel IV over 3 hours followed by cisplatin IV over 2 hours on day 2. On day 8 of course 1, patients also receive fenretinide once in the morning. Treatment repeats every 3 weeks for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response receive 2 additional courses.\n\nCohorts of 3-6 patients receive escalating doses of fenretinide 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\nPROJECTED ACCRUAL: A total of 3-24 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 or cytologically proven refractory solid tumor for which paclitaxel and cisplatin are reasonable therapeutic options\n* No active CNS disease\n\n * CNS metastasis allowed if measurable disease outside of the CNS and patient completed and recovered from 1 prior course of CNS radiotherapy (if clinically indicated)\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nPerformance status:\n\n* ECOG 0-2 OR\n* Zubrod 0-2\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* Platelet count at least 100,000/mm3\n* Absolute neutrophil count at least 1,500/mm3\n\nHepatic:\n\n* Bilirubin no greater than 2.0 mg/dL\n* ALT and AST no greater than 2.5 times upper limit of normal (ULN) (5 times ULN if related to liver metastases)\n\nRenal:\n\n* Creatinine no greater than 1.5 mg/dL\n\nCardiovascular:\n\n* No severe symptomatic cardiac disease\n\nOther:\n\n* No clinically significant/evident retinopathy\n* No other malignancy within the past 5 years except localized nonmelanoma skin cancer or carcinoma in situ of the cervix\n* No uncontrolled infection\n* No other significant medical or psychiatric condition that would increase risk\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception for 1 month before, during, and for at least 2 months after study\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Not specified\n\nChemotherapy:\n\n* See Disease Characteristics\n* No prior paclitaxel, cisplatin, or fenretinide\n* At least 4 weeks since other prior chemotherapy\n\nEndocrine therapy:\n\n* Not specified\n\nRadiotherapy:\n\n* See Disease Characteristics\n* At least 4 weeks since prior radiotherapy to only site of measurable/evaluable disease\n* No prior radiotherapy to more than 25% of bone marrow\n\nSurgery:\n\n* At least 2 weeks since prior therapeutic surgery and recovered\n\nOther:\n\n* At least 4 weeks since prior routine vitamin A of at least 10,000 IU/ day or beta carotene of at least 10 mg/day'}, 'identificationModule': {'nctId': 'NCT00009932', 'briefTitle': 'Combination Chemotherapy in Treating Patients With Solid Tumors', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Phase I Study Of Fenretinide Combined With Paclitaxel And Cisplatin For The Treatment Of Refractory Solid Tumors', 'orgStudyIdInfo': {'id': 'OSU-00H0186'}, 'secondaryIdInfos': [{'id': 'CDR0000068425', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}, {'id': 'NCI-2530'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'cisplatin', 'type': 'DRUG'}, {'name': 'fenretinide', 'type': 'DRUG'}, {'name': 'paclitaxel', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '43210-1240', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Arthur G. James Cancer Hospital - Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Gregory A. Otterson, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Ohio State University Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University Comprehensive Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}]}}}