Actively Recruiting
ICARuS II Trial: Comparing Intraperitoneal and Intravenous Chemotherapy After Surgery and Heated Chemotherapy for Malignant Peritoneal Mesothelioma
Led by Memorial Sloan Kettering Cancer Center · Updated on 2025-07-22
64
Participants Needed
13
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating treatments for people with malignant peritoneal mesothelioma, a rare cancer affecting the lining of the abdomen. This study compares two ways of giving chemotherapy after patients have surgery and heated chemotherapy inside the abdomen, aiming to understand if chemotherapy through the abdomen or through the veins is more effective. The trial is a Phase 2 study sponsored by Memorial Sloan Kettering Cancer Center. Participants receive chemotherapy drugs called pemetrexed and cisplatin, either through intravenous infusions for 4 to 6 cycles or through a catheter placed in the abdomen after surgery and heated chemotherapy. For those receiving intraperitoneal treatment, an abdominal port is inserted once their condition stabilizes, allowing direct delivery of chemotherapy into the abdomen. Carboplatin may replace cisplatin if needed due to hearing, kidney, or nerve issues. During the study, participants are closely monitored for how long they live without the cancer worsening, up to 24 months. Researchers will assess participants' health through regular exams and tests to track treatment effects and safety. The study involves continual follow-up after treatment to observe outcomes and any side effects over time.
CONDITIONS
Brief Title
A Study of Additional Chemotherapy After Surgery for People With Malignant Peritoneal Mesothelioma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient age 18 years or older, both sexes
- Clinical diagnosis of malignant peritoneal mesothelioma confirmed at enrolling institution
- Intraoperative pathologic confirmation of epithelioid malignant peritoneal mesothelioma
- Complete or near-complete cytoreductive surgery achieved
- Patient planning to undergo complete cytoreduction of all peritoneal disease
- ECOG performance status of 0 or 1
- Absolute neutrophil count of at least 1,500/µl
- Platelet count greater than 75,000/µl
- Adequate kidney function: creatinine less than 1.5 times upper normal limit or creatinine clearance at least 50 ml/min
- Adequate liver function: bilirubin less than 1.5 mg/dl (up to 3.0 mg/dl for Gilbert's syndrome)
- Women of childbearing potential must have negative pregnancy test and agree to use effective contraception
- Men must agree to use reliable barrier contraception during the study
- Signed and dated informed consent obtained before study procedures
You will not qualify if you...
- Previous intraperitoneal or systemic chemotherapy for peritoneal mesothelioma
- Prior treatment with platinum-containing chemotherapy regimens
- Biopsy showing sarcomatoid mesothelioma, well-differentiated papillary mesothelioma, or benign multicystic mesothelioma
- Other prior cancers except certain cured or inactive types
- Suspected spread of cancer outside the abdomen
- Pregnant or breastfeeding women
- Active coronary artery disease or uncontrolled hypertension
- Congestive heart failure Class II or higher or severe lung disease
- History of cerebrovascular disease limiting study participation
- Other severe medical problems limiting compliance or increasing risk
- Known allergies to cisplatin, carboplatin, pemetrexed, or mitomycin
- Extensive intraperitoneal adhesions preventing intraperitoneal therapy
- Any condition preventing delivery of appropriate intraperitoneal therapy
- Use of oral medications that cannot be safely stopped for up to 10 days
- Life expectancy less than 12 weeks
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of 4 to 6 chemotherapy cycles
Participants undergo chemotherapy treatment after surgery with either intravenous or intraperitoneal administration of pemetrexed and cisplatin (or carboplatin if needed). Treatment includes 4 to 6 chemotherapy cycles based on clinician discretion.
4 to 6 chemotherapy cycles with visits scheduled per cycle
Duration - Up to 24 months
Participants are monitored for progression-free survival and overall health for up to 24 months after treatment.
Visits scheduled according to clinical follow-up for up to 24 months
Trial Site Locations
Total: 13 locations
1
University of Chicago (Data Collection Only)
Chicago, Illinois, United States, 60637
Actively Recruiting
2
University of Michigan (Data Collection Only)
Ann Arbor, Michigan, United States, 48109
Not Yet Recruiting
3
Washington University (Data Collection Only)
St Louis, Missouri, United States, 63110
Not Yet Recruiting
4
University of Nebraska (Data collection only)
Omaha, Nebraska, United States, 68198-7680
Not Yet Recruiting
5
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
6
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
7
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
8
Rutgers University (Data Collection Only)
New Brunswick, New Jersey, United States, 08903
Not Yet Recruiting
9
Memorial Sloan Kettering Commack (Limited Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
10
Memorial Sloan Kettering Westchester (Limited Protocol Activites)
Harrison, New York, United States, 10604
Actively Recruiting
11
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
12
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States, 11553
Actively Recruiting
13
Allegheny Health Network (Data Collection Only)
Pittsburgh, Pennsylvania, United States, 15212
Actively Recruiting
Research Team
G
Garrett Nash, MD
M
Michael Offin, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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