Gemcitabine and Epirubicin in Treating Patients With Malignant Mesothelioma

Alliance for Clinical Trials in Oncology

Status and phase: Completed; Phase 2

Conditions: Malignant Mesothelioma

Treatments: Drug: epirubicin hydrochloride; Drug: gemcitabine hydrochloride

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00017186

NCCTG-N0021

CDR0000068659 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 69 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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69 participants in 1 patient group

gemcitabine + epirubicin

Experimental group

Description:

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.

Treatment:

Drug: epirubicin hydrochloride

Drug: gemcitabine hydrochloride