NCT00017186

Gemcitabine and Epirubicin in Treating Patients With Malignant Mesothelioma

Phase II Study of Gemcitabine and Epirubicin for the Treatment of Mesothelioma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine and epirubicin in treating patients who have malignant mesothelioma.

Detailed description

OBJECTIVES: * Determine the antitumor activity of gemcitabine and epirubicin in patients with malignant pleural mesothelioma. * Determine the toxicity of this regimen in this patient population. * Determine the time to progression and overall survival of patients treated with this regimen. * Assess quality of life in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and epirubicin IV on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive 2 additional courses beyond CR. Quality of life is assessed at baseline, prior to course 3, at 3 months, and then at 1 year. Patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years.

Conditions

• Malignant Mesothelioma

Interventions

Type	Name	Description
DRUG	epirubicin hydrochloride
DRUG	gemcitabine hydrochloride

Timeline

• Start date: 2001-07-01
• Primary completion: 2004-08-01
• Completion: 2008-05-01
• First posted: 2003-01-27
• Last updated: 2016-12-07

Locations

24 sites across 1 country: United States