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.
|First Received Date||June 6, 2001|
|Last Changed Date||December 5, 2016|
|Start Date||July 2001|
|Actual Primary Completion Date||August 2004|
|Primary Outcome Measures||
time to progression [Time Frame: Up to 5 years]
|Secondary Outcome Measures||
survival [Time Frame: Up to 5 years]
quality of life [Time Frame: Up to 5 years]
|Study Arms / Comparison Groups||1 / 0|
- 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.
|Ages||18 Years - N/A|
|Accepts Healthy Volunteers||No|
- 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
- 18 and over
- ECOG 0-2
- At least 12 weeks
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- AST no greater than 3 times ULN
- Creatinine no greater than 1.5 times ULN
- LVEF at least 50%
- No history of congestive heart failure
- No New York Heart Association class III or IV heart disease
- 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:
- No more than 1 prior chemotherapy regimen for malignant pleural mesothelioma
- No prior gemcitabine or anthracyclines
- No concurrent cimetidine
|Sponsor||Alliance for Clinical Trials in Oncology|
|Verification Date||December 2016|