Expired Study
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Charlottesville, Virginia 22908


Purpose:

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. PURPOSE: 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.


Study summary:

OBJECTIVES: Primary - Determine the maximum tolerated dose of intrapleural docetaxel in patients with malignant pleural effusion. Secondary - Determine the toxicity profile of this drug in these patients. - Determine the pharmacokinetics of this drug in plasma and pleural fluid from these patients. - Determine the response in patients treated with this drug. OUTLINE: This is a dose-escalation study. Patients 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. Cohorts 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. After completion of study treatment, patients are followed at weeks 1 and 3 and then monthly thereafter. PROJECTED ACCRUAL: Approximately 8-24 patients will be accrued for this study.


Criteria:

DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed malignant pleural effusion (MPE) - Symptomatic disease - Candidate for thoracoscopic surgery for treatment of MPE - No known or suspected ipsilateral pleurodesis that would preclude surgery - No bilateral MPEs - No progressive extrapleural disease that is untreatable and/or resistant to systemic treatment PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - Absolute neutrophil count ≥ 1,500/mm^3 - Platelet count ≥ 100,000/mm^3 - Hemoglobin ≥ 8.0 g/dL Hepatic - ALT and/or AST ≤ 1.5 times upper limit of normal (ULN) (if alkaline phosphatase normal) OR - Alkaline phosphatase ≤ 2.5 times ULN (if ALT and/or AST normal) - Bilirubin normal - INR ≤ 1.5 Renal - Creatinine ≤ 1.8 mg/dL Other - Not pregnant - Negative pregnancy test - Fertile patients must use effective contraception during and for ≥ 1 month after completion of study treatment - No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 - No peripheral neuropathy > grade 1 PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No concurrent systemic chemotherapy Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified


NCT ID:

NCT00114205


Primary Contact:

Principal Investigator
David R. Jones, MD
University of Virginia


Backup Contact:

N/A


Location Contact:

Charlottesville, Virginia 22908
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 17, 2017

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