ONCONASE Plus Doxorubicin Versus Doxorubicin Alone For Patients With Malignant Pleural or Peritoneal Mesothelioma Who Have Had No More Than One Prior Chemotherapy Regimen
- Registration Number
- NCT00003034
- Lead Sponsor
- Alfacell
- Brief Summary
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: This randomized phase III trial is studying doxorubicin alone to see how well it works compared to doxorubicin and Onconase in treating patients with malignant mesothelioma.
- Detailed Description
OBJECTIVES:
* Compare the efficacy of doxorubicin with or without ranpirnase in patients with malignant pleural or peritoneal mesothelioma.
* Compare the safety profile of these regimens in these patients.
* 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 ranpirnase 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 ranpirnase as a single agent until disease progression.
* 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 300
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Arm I ranpirnase Patients receive ranpirnase 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 ranpirnase as a single agent until disease progression. Arm I doxorubicin hydrochloride Patients receive ranpirnase 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 ranpirnase as a single agent until disease progression. Arm II doxorubicin hydrochloride Patients receive doxorubicin as in arm I for up to 6 courses.
- Primary Outcome Measures
Name Time Method Survival
- Secondary Outcome Measures
Name Time Method Time to best response Response duration Objective response
Trial Locations
- Locations (19)
Asklepios Klinik St. Georg
🇩🇪Hamburg, Germany
CCOP - Duluth
🇺🇸Duluth, Minnesota, United States
Spectrum Health Hospital - Butterworth Campus
🇺🇸Grand Rapids, Michigan, United States
CCOP - Northern Indiana CR Consortium
🇺🇸South Bend, Indiana, United States
Asklepios Klinik Harburg
🇩🇪Hamburg, Germany
Hospital Grosshansdorf
🇩🇪Grosshansdorf, Germany
Asklepios Fachkliniken Muenchen-Gauting
🇩🇪Gauting, Germany
Istituto Nazionale per la Ricerca sul Cancro
🇮🇹Genoa, Italy
Fondazione I.R.C.C.S. Policlinico San Matteo
🇮🇹Pavia, Italy
University of New Mexico Cancer Research and Treatment Center
🇺🇸Albuquerque, New Mexico, United States
Missouri Cancer Care, PC at St. Joseph Health Center - St. Charles
🇺🇸St. Charles, Missouri, United States
Klinikum Rechts Der Isar - Technische Universitaet Muenchen
🇩🇪Munich, Germany
Ospedale San Martino
🇮🇹Genoa, Italy
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
🇵🇱Warsaw, Poland
Medical University of Gdansk
🇵🇱Gdansk, Poland
University School of Medical Sciences
🇵🇱Poznan, Poland
Methodist Estabrook Cancer Center
🇺🇸Omaha, Nebraska, United States
Klinika Chrorob Pluc I Gruzlicy
🇵🇱Zabrze, Poland
Greenebaum Cancer Center at University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States