Gemcitabine and Epirubicin in Treating Patients With Malignant Mesothelioma

Launched by ALLIANCE FOR CLINICAL TRIALS IN ONCOLOGY · Jan 26, 2003

Keywords

ClinConnect Summary

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 tox...

Gender

ALL

Eligibility 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