Gemcitabine and Epirubicin in Treating Patients With Malignant Mesothelioma

Alliance for Clinical Trials in Oncology69 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Malignant Mesothelioma

Interventions

epirubicin hydrochlorideDRUG

gemcitabine hydrochlorideDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (24)

MBCCOP - Gulf Coast

Mobile, Alabama, United States

Outcomes

Primary Outcomes

time to progression

Time frame: Up to 5 years

Secondary Outcomes

survival

Time frame: Up to 5 years

quality of life

Time frame: Up to 5 years

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.