Mesothelioma Clinical Trials
Doxorubicin Versus Doxorubicin Alone For Patients With
Malignant Pleural or Peritoneal Mesothelioma Who Have Had No
More Than One Prior Chemotherapy Regimen
This study is currently
For more information:National
Cancer Institute (NCI)
RATIONALE: Drugs used in chemotherapy work in different
ways to stop tumor cells from dividing so they stop growing or
die. It is not yet known whether Onconase plus doxorubicin is
more effective than doxorubicin alone in treating patients
with malignant mesothelioma.
PURPOSE: Randomizedphase III trial comparing Onconase plus
doxorubicin with doxorubicin alone in treating patients with
||Treatment or Intervention|
recurrent malignant mesothelioma
This is a Phase III test
- In Phase III studies, the study
drug or treatment is given to large groups of people
(1,000-3,000) to confirm its effectiveness, monitor side
effects, compare it to commonly used treatments, and collect information that will allow
the drug or treatment to be used safely.
Study Type: Interventional
Further Study Details:
- Compare the efficacy of doxorubicin with or without
Onconase in patients with malignant pleural or peritoneal
- Compare the safety profile of these regimens in these
- Compare the overall survival, progression-free survival,
and quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, open-label, controlled,
multicenter study. Patients are stratified according to
disease histology (epithelioid vs nonepithelioid) and CALGB
groups 1-4. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive Onconase IV over 30 minutes
weekly followed by doxorubicin IV. Treatment repeats every 3
weeks for at least 6 courses in the absence of disease
progression. Patients demonstrating evidence of clinical
response or stable disease may continue on maintenance
therapy with Onconase as a single agent until disease
- Arm II: Patients receive doxorubicin as in arm I for up
to 6 courses. Quality of life is assessed.
PROJECTED ACCRUAL: A minimum of 300 patients will be
accrued for this study.
Ages Eligible for Study: 21 Years and
above, Genders Eligible for Study: Both
- Histologically confirmed malignant pleural or peritoneal
- Measurable or evaluable disease
- CALGB groups 1-4
- No CNS