Status:
COMPLETED
Surgery and Intrapleural Docetaxel in Treating Patients With Malignant Pleural Effusion
Lead Sponsor:
University of Virginia
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Metastatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 th...
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 p...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00114205
Start Date
July 1 2003
Last Update
March 18 2010
Active Locations (1)
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1
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908