Surgery and Intrapleural Docetaxel in Treating Patients With Malignant Pleural Effusion

University of Virginia

Status and phase

Completed

Phase 1

Conditions

Metastatic Cancer

Treatments

Procedure: therapeutic thoracoscopy

Drug: docetaxel

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00114205

CDR0000430930

UVACC-29303

UVACC-HIC-10722

Details and patient eligibility

About

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.

Full 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.

Enrollment

24 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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