Ignite Creation Date:
2025-12-25 @ 3:13 AM
Ignite Modification Date:
2026-02-01 @ 4:30 AM
Study NCT ID:
NCT00114205
Status:
COMPLETED
Last Update Posted:
2010-03-18
First Post:
2005-06-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surgery and Intrapleural Docetaxel in Treating Patients With Malignant Pleural Effusion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D016066', 'term': 'Pleural Effusion, Malignant'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010997', 'term': 'Pleural Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D010996', 'term': 'Pleural Effusion'}, {'id': 'D010995', 'term': 'Pleural Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077143', 'term': 'Docetaxel'}], 'ancestors': [{'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': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-08', 'lastUpdateSubmitDate': '2010-03-17', 'studyFirstSubmitDate': '2005-06-13', 'studyFirstSubmitQcDate': '2005-06-13', 'lastUpdatePostDateStruct': {'date': '2010-03-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-06-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum tolerated dose by adverse event evaluation 1 month after treatment'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics by serum and pleural fluid analyses through 1 month'}, {'measure': 'Clinical response by chest x-ray response and survival'}]}, 'conditionsModule': {'keywords': ['malignant pleural effusion'], 'conditions': ['Metastatic Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Giving drugs, such as docetaxel, directly into the pleura after surgery to drain the pleural effusion may help keep fluid from building up again.\n\nPURPOSE: This phase I trial is studying the side effects, best way to give, and best dose of intrapleural docetaxel given after surgery in patients with malignant pleural effusion.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine the maximum tolerated dose of intrapleural docetaxel in patients with malignant pleural effusion.\n\nSecondary\n\n* Determine the toxicity profile of this drug in these patients.\n* Determine the pharmacokinetics of this drug in plasma and pleural fluid from these patients.\n* Determine the response in patients treated with this drug.\n\nOUTLINE: This is a dose-escalation study.\n\nPatients undergo thorascopic surgery to drain the malignant pleural effusion. An intrapleural catheter (Pleurx catheter) is then inserted for subsequent docetaxel instillation. Approximately 24 hours after surgery, patients receive docetaxel intrapleurally over 3 minutes via the Pleurx catheter. The Pleurx catheter is then clamped for 4 hours and the patient is placed in several different positions to ensure uniform distribution of docetaxel throughout the pleural cavity.\n\nCohorts of 3-6 patients receive escalating doses of intrapleural docetaxel 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\nAfter completion of study treatment, patients are followed at weeks 1 and 3 and then monthly thereafter.\n\nPROJECTED ACCRUAL: Approximately 8-24 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 or cytologically confirmed malignant pleural effusion (MPE)\n\n * Symptomatic disease\n* Candidate for thoracoscopic surgery for treatment of MPE\n\n * No known or suspected ipsilateral pleurodesis that would preclude surgery\n* No bilateral MPEs\n* No progressive extrapleural disease that is untreatable and/or resistant to systemic treatment\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 ≥ 1,500/mm\\^3\n* Platelet count ≥ 100,000/mm\\^3\n* Hemoglobin ≥ 8.0 g/dL\n\nHepatic\n\n* ALT and/or AST ≤ 1.5 times upper limit of normal (ULN) (if alkaline phosphatase normal) OR\n* Alkaline phosphatase ≤ 2.5 times ULN (if ALT and/or AST normal)\n* Bilirubin normal\n* INR ≤ 1.5\n\nRenal\n\n* Creatinine ≤ 1.8 mg/dL\n\nOther\n\n* Not pregnant\n* Negative pregnancy test\n* Fertile patients must use effective contraception during and for ≥ 1 month after completion of study treatment\n* No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80\n* No peripheral neuropathy \\> grade 1\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Not specified\n\nChemotherapy\n\n* No concurrent systemic chemotherapy\n\nEndocrine therapy\n\n* Not specified\n\nRadiotherapy\n\n* Not specified\n\nSurgery\n\n* Not specified'}, 'identificationModule': {'nctId': 'NCT00114205', 'briefTitle': 'Surgery and Intrapleural Docetaxel in Treating Patients With Malignant Pleural Effusion', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Phase I Trial of Intrapleural Docetaxel Administered Via an Implantable Catheter in Subjects With a Malignant Pleural Effusion', 'orgStudyIdInfo': {'id': 'CDR0000430930'}, 'secondaryIdInfos': [{'id': 'UVACC-HIC-10722'}, {'id': 'UVACC-29303'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'docetaxel', 'type': 'DRUG'}, {'name': 'therapeutic thoracoscopy', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia Cancer Center', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}], 'overallOfficials': [{'name': 'David R. Jones, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Virginia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Virginia', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}]}}}