A Phase 2 interventional study of epirubicin hydrochloride and gemcitabine hydrochloride in Malignant Mesothelioma, sponsored by Alliance for Clinical Trials in Oncology. Completed at 24 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-12-07.
Sponsored by Alliance for Clinical Trials in Oncology · Phase 2, Interventional, and Treatment
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:
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.
470 studies on the registry are indexed under Mesothelioma; 75 are open to participants now.
This study's enrollment of 69 is above the median of 40 across 371 interventional studies indexed under Mesothelioma.
Browse Mesothelioma studies →Alliance for Clinical Trials in Oncology is the lead sponsor of 499 studies on the registry; 27 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
At least 1 measurable lesion that can be accurately measured in at least one dimension
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Chemotherapy:
Other:
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.
Drug: epirubicin hydrochloride · Drug: gemcitabine hydrochloride
time to progression
Time frame: Up to 5 years
survival
Time frame: Up to 5 years
quality of life
Time frame: Up to 5 years
This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.
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Alliance for Clinical Trials in Oncology