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Surgery and Intrapleural Docetaxel in Treating Patients With Malignant Pleural Effusion

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00114205
First Posted: June 14, 2005
Last Update Posted: March 18, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
  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.


Condition Intervention Phase
Metastatic Cancer Drug: docetaxel Procedure: therapeutic thoracoscopy Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase I Trial of Intrapleural Docetaxel Administered Via an Implantable Catheter in Subjects With a Malignant Pleural Effusion

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Maximum tolerated dose by adverse event evaluation 1 month after treatment

Secondary Outcome Measures:
  • Pharmacokinetics by serum and pleural fluid analyses through 1 month
  • Clinical response by chest x-ray response and survival

Estimated Enrollment: 24
Study Start Date: July 2003
Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00114205


Locations
United States, Virginia
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of Virginia
National Cancer Institute (NCI)
Investigators
Principal Investigator: David R. Jones, MD University of Virginia
  More Information

ClinicalTrials.gov Identifier: NCT00114205     History of Changes
Other Study ID Numbers: CDR0000430930
UVACC-HIC-10722
UVACC-29303
First Submitted: June 13, 2005
First Posted: June 14, 2005
Last Update Posted: March 18, 2010
Last Verified: August 2006

Keywords provided by National Cancer Institute (NCI):
malignant pleural effusion

Additional relevant MeSH terms:
Neoplasm Metastasis
Pleural Effusion
Pleural Effusion, Malignant
Neoplastic Processes
Neoplasms
Pathologic Processes
Pleural Diseases
Respiratory Tract Diseases
Pleural Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action