Gemcitabine and Epirubicin in Treating Patients With Malignant Mesothelioma
- Conditions
- Malignant Mesothelioma
- Interventions
- Registration Number
- NCT00017186
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 69
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description gemcitabine + epirubicin epirubicin hydrochloride 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. gemcitabine + epirubicin gemcitabine hydrochloride 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.
- Primary Outcome Measures
Name Time Method time to progression Up to 5 years
- Secondary Outcome Measures
Name Time Method survival Up to 5 years quality of life Up to 5 years
Trial Locations
- Locations (24)
CCOP - Mayo Clinic Scottsdale Oncology Program
🇺🇸Scottsdale, Arizona, United States
Rapid City Regional Hospital
🇺🇸Rapid City, South Dakota, United States
CCOP - Sioux Community Cancer Consortium
🇺🇸Sioux Falls, South Dakota, United States
Coborn Cancer Center
🇺🇸Saint Cloud, Minnesota, United States
CCOP - Metro-Minnesota
🇺🇸Saint Louis Park, Minnesota, United States
CCOP - Ochsner
🇺🇸New Orleans, Louisiana, United States
CCOP - Illinois Oncology Research Association
🇺🇸Peoria, Illinois, United States
Mayo Clinic - Jacksonville
🇺🇸Jacksonville, Florida, United States
CCOP - Duluth
🇺🇸Duluth, Minnesota, United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
🇺🇸Green Bay, Wisconsin, United States
CCOP - Geisinger Clinic and Medical Center
🇺🇸Danville, Pennsylvania, United States
CCOP - Toledo Community Hospital
🇺🇸Toledo, Ohio, United States
CCOP - Upstate Carolina
🇺🇸Spartanburg, South Carolina, United States
CCOP - Merit Care Hospital
🇺🇸Fargo, North Dakota, United States
Siouxland Hematology-Oncology
🇺🇸Sioux City, Iowa, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
MBCCOP - Gulf Coast
🇺🇸Mobile, Alabama, United States
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
CCOP - Cedar Rapids Oncology Project
🇺🇸Cedar Rapids, Iowa, United States
Medcenter One Health System
🇺🇸Bismarck, North Dakota, United States
CCOP - Michigan Cancer Research Consortium
🇺🇸Ann Arbor, Michigan, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
CCOP - Missouri Valley Cancer Consortium
🇺🇸Omaha, Nebraska, United States
CCOP - Iowa Oncology Research Association
🇺🇸Des Moines, Iowa, United States