Mesothelioma Clinical Trials
Epirubicin in Treating Patients With Malignant
This study is currently
North Central Cancer Treatment
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.
||Treatment or Intervention|
recurrent malignant mesothelioma
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
Official Title: Phase II Study of
Gemcitabine and Epirubicin in Patients With Malignant Pleural
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
- Determine the time to progression and overall survival
of patients treated with this regimen.
- Assess quality of life in patients treated with this
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
- At least 1 measurable lesion that can be accurately
measured in at least one dimension
- At least 20 mm (2 cm) in diameter