Malignant Peritoneal MesotheliomaPhase 2NCT06057935
A Study of Additional Chemotherapy After Surgery for People With Malignant Peritoneal Mesothelioma
A Phase 2 study testing Pemetrexed, Cisplatin and Carboplatin in people with Malignant Peritoneal Mesothelioma and Peritoneal Mesothelioma, run by Memorial Sloan Kettering Cancer Center at 13 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Peritoneal Mesothelioma, Peritoneal Mesothelioma, Mesothelioma
- What is being tested?
- Pemetrexed, Cisplatin and Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 13 sitesUnited States
- Study dates
- 21 Sep 2023to 21 Sep 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- Subjects who have previously undergone intraperitoneal chemotherapy or systemic chemotherapy/immunotherapy for peritoneal mesothelioma.
- Subjects who have previously received platinum-containing chemotherapy regimens.
- Subjects with preoperative or intraoperative biopsy consistent with sarcomatoid mesothelioma, well-differentiated papillary mesothelioma, or benign multicystic mesothelioma.
- Other prior malignancies, except for cured non-melanoma skin cancer, curatively treated in situ carcinoma of the cervix, adequately treated malignancies for which there has been no evidence of activity for more than three years, or indolent tumors for which observation over two years is a reasonable option.
- High suspicion for extra-abdominal metastases.
- Women who are pregnant or lactating.
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- Active coronary artery disease (defined as unstable angina or a positive cardiac stress test). Subjects with a history of coronary artery disease may be included if they have had a normal stress test within 60 days of enrollment or are determined by a cardiologist to be of acceptable perioperative risk.
- Uncontrolled hypertension defined as >140/90 and not cleared for surgery at the time of consent.
- New York Heart Association (NYHA) Class II or higher congestive heart failure; restrictive or obstructive pulmonary disease that would limit study compliance or place the patient at unacceptable risk for participation in the study.
- History of cerebrovascular disease that would limit study compliance or place the patient at unacceptable risk for participation in the study.
- Subjects with other concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study or place them at an unacceptable risk for participation in the study.
- Patients with known cisplatin, carboplatin, pemetrexed or mitomycin allergy.
- Evidence of extensive intraperitoneal adhesions at the time of surgery which prohibits intraperitoneal therapy, as determined by the operating surgeon.
- Any condition that would preclude the ability to deliver appropriate IP therapy.
- Use of an oral medication, lacking a suitable non-oral substitute, that if held for up to ten days, would be felt an unacceptable risk by the investigator.
- Life expectancy < 12 weeks.
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
United States13 sites, 13 recruiting
- Not yet recruiting
University of Michigan (Data Collection Only)
Ann Arbor, Michigan, 48109
Donnele Daley, MD, 734-647-8902
- Recruiting
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
Garrett Nash, MD, MPH, 212-639-8668
- Recruiting
University of Chicago (Data Collection Only)
Chicago, Illinois, 60637
Hedy Kindler, MD, 773-702-1470
- Recruiting
Memorial Sloan Kettering Commack (Limited Protocol Activities)
Commack, New York, 11725
Garrett Nash, MD, 212-639-8668
- Recruiting
Memorial Sloan Kettering Westchester (Limited Protocol Activites)
Harrison, New York, 10604
Garrett Nash, MD, 212-639-8668
- Recruiting
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748
Garrett Nash, MD, 212-639-8668
- Recruiting
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
Garrett Nash, MD, 212-639-8668
- Not yet recruiting
Rutgers University (Data Collection Only)
New Brunswick, New Jersey, 08903
H. Richard Alexander, MD, 732-235-6780
- Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Garrett Nash, MD, 212-639-8668
- Not yet recruiting
University of Nebraska (Data collection only)
Omaha, Nebraska, 68198-7680
Jason Foster, MD, 402-559-8941
- Recruiting
Allegheny Health Network (Data Collection Only)
Pittsburgh, Pennsylvania, 15212
Patrick Wagner, MD, 833-246-7662
- Not yet recruiting
Washington University (Data Collection Only)
St Louis, Missouri, 63110
Trang Nguyen, MD, 314-362-2280
- Recruiting
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, 11553
Garrett Nash, MD, 212-639-8668
About this study
Official title: 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
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.
- Conditions
- Malignant Peritoneal Mesothelioma, Peritoneal Mesothelioma, Mesothelioma, Mesothelioma, Malignant, Malignant Mesothelioma
- Being tested
- Pemetrexed, Cisplatin, Carboplatin
- Keywords
- Malignant Peritoneal Mesothelioma, Peritoneal Mesothelioma, Mesothelioma, Mesothelioma, Malignant, Malignant Mesothelioma, ICARuS II, Memorial Sloan Kettering Cancer Center, 23-145
- Medical subject headings
- Mesothelioma, Mesothelioma, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PemetrexedDrug
Pemetrexed will be administered intravenously
CisplatinDrug
Cisplatin will be administered intravenously
CarboplatinDrug
Possible substitution with carboplatin based on clinician discretion
| Study group | Role | What they receive |
|---|---|---|
| IVC arm | Experimental | 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. Receives: Drug: Pemetrexed; Drug: Cisplatin; Drug: Carboplatin |
| NIPC arm | Active comparator | 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. Receives: Drug: Pemetrexed; Drug: Cisplatin; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Progression Free Survival in the two treatment arms.
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start21 Sep 2023
- Primary completion21 Sep 2028 (estimated)
- Study completion21 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Peritoneal MesotheliomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Garrett Nash, MD, Principal investigator, Memorial Sloan Kettering Cancer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06057935
- Sponsor's protocol ID
- 23-145
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2023
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.