Surgery and Intrapleural Docetaxel in Treating Patients With Malignant Pleural Effusion

Metastatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00114205
• Other study ID #: CDR0000430930
• Secondary ID: UVACC-HIC-10722U
• Status: Completed
• Phase: Phase 1
• First received: June 13, 2005
• Last updated: March 17, 2010
• Start date: July 2003

Study information

• Verified date: August 2006
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metastatic Cancer
• Neoplasm Metastasis
• Pleural Effusion
• Pleural Effusion, Malignant

Intervention

Drug:
• docetaxel

Procedure:
• therapeutic thoracoscopy

Locations

Country	Name	City	State
United States	University of Virginia Cancer Center	Charlottesville	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
University of Virginia	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose by adverse event evaluation 1 month after treatment			Yes
Secondary	Pharmacokinetics by serum and pleural fluid analyses through 1 month			No
Secondary	Clinical response by chest x-ray response and survival			No