Surgery and Intrapleural Docetaxel in Treating Patients With Malignant Pleural Effusion

NCT00114205 | Completed Phase 1

• 3 other identifiers: CDR0000430930UVACC-HIC-10722UVACC-29303
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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 the side effects, best way to give, and best dose of intrapleural docetaxel given after surgery in patients with malignant pleural effusion.

Conditions

Metastatic Cancer

Keywords

malignant pleural effusion

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose by adverse event evaluation 1 month after treatment

Secondary Outcomes (2)

• Pharmacokinetics by serum and pleural fluid analyses through 1 month

• Clinical response by chest x-ray response and survival

Interventions

docetaxel DRUG

therapeutic thoracoscopy PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Virginia: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Virginia Cancer Center

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Neoplasm Metastasis; Pleural Effusion, Malignant

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pleural Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Pleural Effusion; Pleural Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• David R. Jones, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 13, 2005
• First Posted: June 14, 2005
• Study Start: July 1, 2003
• Last Updated: March 18, 2010

Record last verified: 2006-08

Locations

US (1)