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Mesothelioma Clinical Trials

Gemcitabine and Epirubicin in Treating Patients With Malignant Mesothelioma

This study is currently recruiting patients.

Sponsored by

North Central Cancer Treatment Group
For more information:National Cancer Institute (NCI)

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.

Condition Treatment or Intervention
localized malignant mesothelioma
advanced malignant mesothelioma
recurrent malignant mesothelioma
Drug: epirubicin
Drug: gemcitabine
Procedure: chemotherapy

This is a Phase II test

  • In Phase II clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Gemcitabine and Epirubicin in Patients With Malignant Pleural Mesothelioma

Further Study Details: 


  • 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.

PROJECTED ACCRUAL: A total of 15-41 patients will be accrued for this study within 6-18 months.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both



  • 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

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