A Study of Additional Chemotherapy After Surgery for People With Malignant Peritoneal Mesothelioma
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| ClinicalTrials.gov Identifier: NCT06057935 |
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Recruitment Status :
Recruiting
First Posted : September 28, 2023
Last Update Posted : April 25, 2024
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Sponsor:
Memorial Sloan Kettering Cancer Center
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Malignant Peritoneal Mesothelioma Peritoneal Mesothelioma Mesothelioma Mesothelioma, Malignant Malignant Mesothelioma | Drug: Pemetrexed Drug: Cisplatin Drug: Carboplatin | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 64 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | September 21, 2023 |
| Estimated Primary Completion Date : | September 21, 2028 |
| Estimated Study Completion Date : | September 21, 2028 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Mesothelioma
| Arm | Intervention/treatment |
|---|---|
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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.
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Drug: Pemetrexed
Pemetrexed will be administered intravenously Drug: Cisplatin Cisplatin will be administered intravenously Drug: Carboplatin Possible substitution with carboplatin based on clinician discretion |
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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.
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Drug: Pemetrexed
Pemetrexed will be administered intravenously Drug: Cisplatin Cisplatin will be administered intravenously Drug: Carboplatin Possible substitution with carboplatin based on clinician discretion |
Primary Outcome Measures :
- Progression Free Survival [ Time Frame: up to 24 months ]Progression Free Survival in the two treatment arms.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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 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.
Exclusion Criteria:
- Subjects who have previously undergone intraperitoneal chemotherapy or systemic chemotherapy 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.
- 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06057935
Contacts
| Contact: Garrett Nash, MD | 212-639-8668 | nashg@mskcc.org | |
| Contact: Michael Offin, MD | 646-608-3763 | offinm@mskcc.org |
Locations
| United States, Illinois | |
| University of Chicago (Data Collection Only) | Not yet recruiting |
| Chicago, Illinois, United States, 60637 | |
| Contact: Hedy Kindler, MD 773-702-1470 | |
| United States, Nebraska | |
| University of Nebraska (Data collection only) | Not yet recruiting |
| Omaha, Nebraska, United States, 68198-7680 | |
| Contact: Jason Foster, MD 402-559-8941 | |
| United States, New Jersey | |
| Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) | Recruiting |
| Basking Ridge, New Jersey, United States, 07920 | |
| Contact: Garrett Nash, MD, MPH 212-639-8668 | |
| Memorial Sloan Kettering Monmouth (Limited Protocol Activities) | Recruiting |
| Middletown, New Jersey, United States, 07748 | |
| Contact: Garrett Nash, MD 212-639-8668 | |
| Memorial Sloan Kettering Bergen (Limited Protocol Activities) | Recruiting |
| Montvale, New Jersey, United States, 07645 | |
| Contact: Garrett Nash, MD 212-639-8668 | |
| Rutgers University (Data Collection Only) | Not yet recruiting |
| New Brunswick, New Jersey, United States, 08903 | |
| Contact: H. Richard Alexander, MD 732-235-6780 | |
| United States, New York | |
| Memorial Sloan Kettering Commack (Limited Protocol Activities) | Recruiting |
| Commack, New York, United States, 11725 | |
| Contact: Garrett Nash, MD 212-639-8668 | |
| Memorial Sloan Kettering Westchester (Limited Protocol Activites) | Recruiting |
| Harrison, New York, United States, 10604 | |
| Contact: Garrett Nash, MD 212-639-8668 | |
| Memorial Sloan Kettering Cancer Center (All Protocol Activities) | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Garrett Nash, MD 212-639-8668 | |
| Memorial Sloan Kettering Nassau (Limited Protocol Activities) | Recruiting |
| Uniondale, New York, United States, 11553 | |
| Contact: Garrett Nash, MD 212-639-8668 | |
| United States, Pennsylvania | |
| Allegheny Health Network (Data Collection Only) | Not yet recruiting |
| Pittsburgh, Pennsylvania, United States, 15212 | |
| Contact: Patrick Wagner, MD 833-246-7662 | |
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
| Principal Investigator: | Garrett Nash, MD | Memorial Sloan Kettering Cancer |
Additional Information:
| Responsible Party: | Memorial Sloan Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT06057935 |
| Other Study ID Numbers: |
23-145 |
| First Posted: | September 28, 2023 Key Record Dates |
| Last Update Posted: | April 25, 2024 |
| Last Verified: | April 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | 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. |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Memorial Sloan Kettering Cancer Center:
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Malignant Peritoneal Mesothelioma Peritoneal Mesothelioma Mesothelioma Mesothelioma, Malignant |
Malignant Mesothelioma ICARuS II Memorial Sloan Kettering Cancer Center 23-145 |
Additional relevant MeSH terms:
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Mesothelioma Mesothelioma, Malignant Adenoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Mesothelial Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Pleural Neoplasms Lung Diseases Respiratory Tract Diseases Carboplatin Pemetrexed Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |