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Gemcitabine and Epirubicin in Treating Patients With Malignant Mesothelioma

Brief Summary

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.

Tracking Information
First Received DateJune 6, 2001
Last Changed DateDecember 5, 2016
Start DateJuly 2001
Actual Primary Completion DateAugust 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]

Descriptive Information
PhasePhase 2
Study TypeInterventional
Condition
  • Malignant Mesothelioma
Intervention
  • Drug: epirubicin hydrochloride
  • Drug: gemcitabine hydrochloride
Study Arms / Comparison Groups1 / 0
Detailed 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.

Recruitment Information
Recruitment StatusCompleted
Actual Enrollment69
GenderAll
Ages18 Years - N/A
Accepts Healthy VolunteersNo
Eligibility 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

Administrative Information
NCTIDNCT00017186
Responsible Party,
SponsorAlliance for Clinical Trials in Oncology
Verification DateDecember 2016
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