Malignant Mesothelioma
Conditions
Keywords
localized malignant mesothelioma, advanced malignant mesothelioma, recurrent malignant mesothelioma
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.
Interventions
DRUGepirubicin hydrochloride
DRUGgemcitabine hydrochloride
Sponsors
National Cancer Institute (NCI)
Alliance for Clinical Trials in Oncology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed malignant pleural mesothelioma * At least 1 measurable lesion that can be accurately measured in at least one dimension * At least 20 mm (2 cm) in diameter PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * At least 12 weeks Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * AST no greater than 3 times ULN Renal: * Creatinine no greater than 1.5 times ULN Cardiovascular: * LVEF at least 50% * No history of congestive heart failure * No New York Heart Association class III or IV heart disease Other: * No uncontrolled infection * No other severe underlying disease that would preclude study participation * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, noninvasive carcinomas, or localized prostate cancer * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 6 months after study participation PRIOR CONCURRENT THERAPY: Chemotherapy: * No more than 1 prior chemotherapy regimen for malignant pleural mesothelioma * No prior gemcitabine or anthracyclines Other: * No concurrent cimetidine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| time to progression | Up to 5 years |
Secondary
| Measure | Time frame |
|---|---|
| survival | Up to 5 years |
| quality of life | Up to 5 years |
Countries
United States
Outcome results
None listed