Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-27 @ 10:49 PM
Study NCT ID:
NCT00084734
Status:
COMPLETED
Last Update Posted:
2023-08-04
First Post:
2004-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Docetaxel, Capecitabine, and Cisplatin in Treating Patients With Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069287', 'term': 'Capecitabine'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D000077143', 'term': 'Docetaxel'}], 'ancestors': [{'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'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': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-02', 'studyFirstSubmitDate': '2004-06-10', 'studyFirstSubmitQcDate': '2004-06-10', 'lastUpdatePostDateStruct': {'date': '2023-08-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2004-06-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine the maximum tolerated dose of docetaxel, cisplatin, and capecitabine in patients with advanced solid tumors.', 'timeFrame': 'Every 21 days'}], 'secondaryOutcomes': [{'measure': 'Determine the non-dose-limiting toxic effects associated with this regimen in these patients', 'timeFrame': 'Every 21 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['unspecified adult solid tumor, protocol specific'], 'conditions': ['Unspecified Adult Solid Tumor, Protocol Specific']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy, such as docetaxel, capecitabine, and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one chemotherapy drug may kill more tumor cells.\n\nPURPOSE: This phase I trial is studying the side effects and best dose of docetaxel, capecitabine, and cisplatin in treating patients with metastatic or unresectable solid tumors.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine the maximum tolerated dose of docetaxel, cisplatin, and capecitabine in patients with advanced solid tumors.\n* Determine the dose-limiting toxicity and recommended phase II dose of this regimen in these patients.\n\nSecondary\n\n* Determine the non-dose-limiting toxic effects associated with this regimen in these patients.\n* Determine the pharmacokinetics of this regimen in these patients.\n* Determine any clinical activity of this regimen in these patients.\n\nOUTLINE: This is a dose-escalation study.\n\nPatients receive docetaxel IV over 30 minutes and cisplatin IV over 30 minutes on days 1 and 8 and oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.\n\nCohorts of 3-6 patients receive escalating doses of docetaxel, cisplatin, and capecitabine 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. At least 6 patients receive treatment at the MTD.\n\nPROJECTED ACCRUAL: A minimum of 21 patients will be accrued for this study within 1.5 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed solid tumor for which standard curative or palliative measures do not exist or are no longer effective\n\n * Metastatic or unresectable disease\n* No known brain metastases\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nPerformance status\n\n* ECOG 0-2\n\nLife expectancy\n\n* More than 12 weeks\n\nHematopoietic\n\n* Absolute neutrophil count ≥ 1,500/mm\\^3\n* Platelet count ≥ 100,000/mm\\^3\n* Hemoglobin ≥ 8.0 g/dL\n\nHepatic\n\n* AST and ALT ≤ 2.0 times upper limit of normal (ULN) AND alkaline phosphatase \\[AP\\] \\< ULN OR\n* AP ≤ 4 times ULN AND AST and ALT \\< ULN\n* Bilirubin normal\n\nRenal\n\n* Creatinine ≤ 1.5 mg/dL OR\n* Creatinine clearance ≥ 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* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* Able to ingest oral medications\n* No allergy attributed to study drugs, compounds of similar chemical or biological composition, drugs formulated in polysorbate 80, or other agents used in this study\n* No inner ear auditory toxicity ≥ grade 2\n* No peripheral neuropathy ≥ grade 2\n* No immunodeficiency\n* No active or ongoing infection\n* No psychiatric illness or social situation that would preclude study compliance\n* No other concurrent uncontrolled illness\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* No concurrent growth factors (sargramostim \\[GM-CSF\\] or filgrastim \\[G-CSF\\])\n\nChemotherapy\n\n* More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered\n\nEndocrine therapy\n\n* Not specified\n\nRadiotherapy\n\n* More than 4 weeks since prior radiotherapy and recovered\n\nSurgery\n\n* Not specified\n\nOther\n\n* No other concurrent investigational agents unless approved by the principal investigator and medical monitor\n* No other concurrent anticancer therapy'}, 'identificationModule': {'nctId': 'NCT00084734', 'briefTitle': 'Docetaxel, Capecitabine, and Cisplatin in Treating Patients With Advanced Solid Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Roswell Park Cancer Institute'}, 'officialTitle': 'A Phase I and Pharmacokinetics Study of Docetaxel in Combination With Capecitabine and Cisplatin in Solid Tumors', 'orgStudyIdInfo': {'id': 'CDR0000365571'}, 'secondaryIdInfos': [{'id': 'RPCI-RPC-0209'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'capecitabine', 'type': 'DRUG', 'description': 'Oral'}, {'name': 'cisplatin', 'type': 'DRUG', 'description': 'IV'}, {'name': 'docetaxel', 'type': 'DRUG', 'description': 'IV'}]}, 'contactsLocationsModule': {'locations': [{'zip': '14263-0001', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Roswell Park Cancer Institute', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}], 'overallOfficials': [{'name': 'Marwan Fakih, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Roswell Park Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Roswell Park Cancer Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}