Phase II Study of Gemcitabine and Epirubicin for the Treatment of Mesothelioma
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.
PROJECTED ACCRUAL: A total of 15-41 patients will be accrued for this study within 6-18
months.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Scott Okuno, MD
Study Chair
Mayo Clinic
United States: Federal Government
CDR0000068659
NCT00017186
July 2001
Name | Location |
---|---|
Mayo Clinic - Jacksonville | Jacksonville, Florida 32224 |
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
CCOP - Duluth | Duluth, Minnesota 55805 |
CCOP - Cedar Rapids Oncology Project | Cedar Rapids, Iowa 52403-1206 |
Siouxland Hematology-Oncology | Sioux City, Iowa 51101-1733 |
CCOP - Ochsner | New Orleans, Louisiana 70121 |
CCOP - Merit Care Hospital | Fargo, North Dakota 58122 |
Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
CCOP - Sioux Community Cancer Consortium | Sioux Falls, South Dakota 57105-1080 |
CCOP - Geisinger Clinic and Medical Center | Danville, Pennsylvania 17822-2001 |
CCOP - St. Vincent Hospital Cancer Center, Green Bay | Green Bay, Wisconsin 54301 |
MBCCOP - Gulf Coast | Mobile, Alabama 36688 |
CCOP - Toledo Community Hospital | Toledo, Ohio 43623-3456 |
Medcenter One Health System | Bismarck, North Dakota 58501 |
Coborn Cancer Center | Saint Cloud, Minnesota 56303 |
CCOP - Mayo Clinic Scottsdale Oncology Program | Scottsdale, Arizona 85259 |