Gemcitabine and Epirubicin in Treating Patients With Malignant 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.

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