Surgery and Intrapleural Docetaxel in Treating Patients With Malignant Pleural Effusion

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phase I Trial of Intrapleural Docetaxel Administered Via an Implantable Catheter in Subjects With a Malignant Pleural Effusion

Conditions
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Metastatic Cancer

Intervention / Treatment
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* Drug: docetaxel
* Procedure: therapeutic thoracoscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: docetaxel|nan|
|Procedure: therapeutic thoracoscopy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum tolerated dose by adverse event evaluation 1 month after treatment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics by serum and pleural fluid analyses through 1 month |  |  | 
| Clinical response by chest x-ray response and survival |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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malignant pleural effusion