Surgery and Intrapleural Docetaxel in Treating Patients With Malignant Pleural Effusion - Full Text View

Sponsors and Collaborators:	University of Virginia National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00114205

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: thoracoscopic surgery	Phase I

MedlinePlus related topics: Cancer

Drug Information available for: Docetaxel

U.S. FDA Resources

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

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

Primary Outcome Measures:

Maximum tolerated dose by adverse event evaluation 1 month after treatment [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Pharmacokinetics by serum and pleural fluid analyses through 1 month [ Designated as safety issue: No ]
Clinical response by chest x-ray response and survival [ Designated as safety issue: No ]

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000430930, UVACC-HIC-10722, UVACC-29303
Study First Received:	June 13, 2005
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00114205
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

malignant pleural effusion

Study placed in the following topic categories:

Docetaxel
Thoracic Neoplasms
Pleural Effusion
Respiratory Tract Diseases

Pleural Diseases
Neoplasm Metastasis
Pleural Effusion, Malignant
Pleural Neoplasms

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplastic Processes
Neoplasms by Site

Pathologic Processes
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009