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

Status: Recruiting
Location: See all (13) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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 function: bilirubin \< 1.5 mg/dl (except in patients with Gilbert's syndrome, who must have total bilirubin \< 3.0 mg/dL).

• Women of childbearing potential with a negative pregnancy test result (urine or blood) who agree to use an effective contraceptive method. Reliable contraception should be used from trial screening and must be continued throughout the study. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant.

• A man participating in this study must agree to utilize a reliable barrier form of contraception for the duration of the study

• Signed and dated written informed consent to participate in this clinical trial must be obtained prior to any study procedure.

Locations
United States
Illinois
University of Chicago (Data Collection Only)
RECRUITING
Chicago
Michigan
University of Michigan (Data Collection Only)
NOT_YET_RECRUITING
Ann Arbor
Missouri
Washington University (Data Collection Only)
NOT_YET_RECRUITING
St Louis
Nebraska
University of Nebraska (Data collection only)
NOT_YET_RECRUITING
Omaha
New Jersey
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
RECRUITING
Basking Ridge
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
RECRUITING
Middletown
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
RECRUITING
Montvale
Rutgers University (Data Collection Only)
NOT_YET_RECRUITING
New Brunswick
New York
Memorial Sloan Kettering Commack (Limited Protocol Activities)
RECRUITING
Commack
Memorial Sloan Kettering Westchester (Limited Protocol Activites)
RECRUITING
Harrison
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
RECRUITING
New York
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
RECRUITING
Uniondale
Pennsylvania
Allegheny Health Network (Data Collection Only)
RECRUITING
Pittsburgh
Contact Information
Primary
Garrett Nash, MD
nashg@mskcc.org
212-639-8668
Backup
Michael Offin, MD
offinm@mskcc.org
646-608-3763
Time Frame
Start Date: 2023-09-21
Estimated Completion Date: 2028-09-21
Participants
Target number of participants: 64
Treatments
Experimental: IVC arm
Pemetrexed and cisplatin will be administered intravenously for a total of 4 to 6 cycles. Participants will receive 4 cycles, but can receive up to 6 cycles based on clinician discretion. Substitution with carboplatin allowed for pre-existing impairment of hearing, renal function, or neuropathy.
Active_comparator: NIPC arm
After completion of hyperthermic intraperitoneal chemotherapy/HIPEC, an intraperitoneal catheter with a subcutaneous reservoir will be inserted through the abdominal wall. When the participant's condition is considered stable by the physicians, the NIPC will be started. Pemetrexed and either cisplatin or carboplatin will be administered through the intraperitoneal port.
Related Therapeutic Areas
Sponsors
Leads: Memorial Sloan Kettering Cancer Center

This content was sourced from clinicaltrials.gov