ICARuS II (Intraperitoneal Chemotherapy After cytoReductive Surgery): A Multicenter, Randomized Phase II Trial of Normothermic Intraperitoneal Chemotherapy and Intravenous Chemotherapy After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy for Malignant Peritoneal Mesothelioma
Memorial Sloan Kettering Cancer Center
Summary
The purpose of this study is to find out whether intraperitoneal or intravenous chemotherapy given after cytoreductive surgery and HIPEC are effective treatments for people with malignant peritoneal mesothelioma. Outcomes will be compared by observing intraperitoneal versus intravenous treatments to analyze if one is better than the other.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patient age 18 years or older, both sexes. * Clinical diagnosis of MPM at enrolling institution. * Prior to randomization, intraoperative pathologic confirmation of epithelioid MPM at enrolling institution. * Complete or near-complete CRS achieved. * Patient must be planning to undergo complete cytoreduction of all peritoneal disease. * ECOG performance status ≤ 1. * Hematology: ANC ≥ 1,500/µl. * Platelets \> 75,000/µl. * Adequate renal function: creatinine \< 1.5× the upper limit of normal (ULN) or calculated creatinine clearance of ≥50 ml/min. * Adequate hepatic functi…
Interventions
- DrugPemetrexed
Pemetrexed will be administered intravenously
- DrugCisplatin
Cisplatin will be administered intravenously
- DrugCarboplatin
Possible substitution with carboplatin based on clinician discretion
Locations (13)
- University of Chicago (Data Collection Only)Chicago, Illinois
- University of Michigan (Data Collection Only)Ann Arbor, Michigan
- Washington University (Data Collection Only)St Louis, Missouri
- University of Nebraska (Data collection only)Omaha, Nebraska
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities)Middletown, New Jersey