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


Phase 1
18 Years
N/A
Not Enrolling
Both
Metastatic Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose by adverse event evaluation 1 month after treatment

Safety Issue:

Yes

Principal Investigator

David R. Jones, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Virginia

Authority:

United States: Federal Government

Study ID:

CDR0000430930

NCT ID:

NCT00114205

Start Date:

July 2003

Completion Date:

Related Keywords:

  • Metastatic Cancer
  • malignant pleural effusion
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary
  • Pleural Effusion
  • Pleural Effusion, Malignant

Name

Location

University of Virginia Cancer CenterCharlottesville, Virginia  22908