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A Study of Additional Chemotherapy After Surgery for People With Malignant Peritoneal Mesothelioma

Primary Purpose

Malignant Peritoneal Mesothelioma, Peritoneal Mesothelioma, Mesothelioma

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Pemetrexed
Cisplatin
Carboplatin
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Peritoneal Mesothelioma focused on measuring Malignant Peritoneal Mesothelioma, Peritoneal Mesothelioma, Mesothelioma, Mesothelioma, Malignant, Malignant Mesothelioma, ICARuS II, Memorial Sloan Kettering Cancer Center, 23-145

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Chicago (Data Collection Only)
  • University of Nebraska (Data collection only)
  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Recruiting
  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)Recruiting
  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)Recruiting
  • Rutgers University (Data Collection Only)
  • Memorial Sloan Kettering Commack (Limited Protocol Activities)Recruiting
  • Memorial Sloan Kettering Westchester (Limited Protocol Activites)Recruiting
  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)Recruiting
  • Memorial Sloan Kettering Nassau (Limited Protocol Activities)Recruiting
  • Allegheny Health Network (Data Collection Only)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IVC arm

NIPC arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Progression Free Survival
Progression Free Survival in the two treatment arms.

Secondary Outcome Measures

Full Information

First Posted
September 21, 2023
Last Updated
September 21, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT06057935
Brief Title
A Study of Additional Chemotherapy After Surgery for People With Malignant Peritoneal Mesothelioma
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 21, 2023 (Actual)
Primary Completion Date
September 21, 2028 (Anticipated)
Study Completion Date
September 21, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Peritoneal Mesothelioma, Peritoneal Mesothelioma, Mesothelioma, Mesothelioma, Malignant, Malignant Mesothelioma
Keywords
Malignant Peritoneal Mesothelioma, Peritoneal Mesothelioma, Mesothelioma, Mesothelioma, Malignant, Malignant Mesothelioma, ICARuS II, Memorial Sloan Kettering Cancer Center, 23-145

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IVC arm
Arm Type
Experimental
Arm Description
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.
Arm Title
NIPC arm
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Intervention Description
Pemetrexed will be administered intravenously
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Cisplatin will be administered intravenously
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Possible substitution with carboplatin based on clinician discretion
Primary Outcome Measure Information:
Title
Progression Free Survival
Description
Progression Free Survival in the two treatment arms.
Time Frame
up to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Garrett Nash, MD
Phone
212-639-8668
Email
nashg@mskcc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Offin, MD
Phone
646-608-3763
Email
offinm@mskcc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Garrett Nash, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago (Data Collection Only)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hedy Kindler, MD
Phone
773-702-1470
Facility Name
University of Nebraska (Data collection only)
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-7680
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jason Foster, MD
Phone
402-559-8941
Facility Name
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Garrett Nash, MD, MPH
Phone
212-639-8668
Facility Name
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Garrett Nash, MD
Phone
212-639-8668
Facility Name
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Garrett Nash, MD
Phone
212-639-8668
Facility Name
Rutgers University (Data Collection Only)
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
H. Richard Alexander, MD
Phone
732-235-6780
Facility Name
Memorial Sloan Kettering Commack (Limited Protocol Activities)
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Garrett Nash, MD
Phone
212-639-8668
Facility Name
Memorial Sloan Kettering Westchester (Limited Protocol Activites)
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Garrett Nash, MD
Phone
212-639-8668
Facility Name
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Garrett Nash, MD
Phone
212-639-8668
Facility Name
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
City
Uniondale
State/Province
New York
ZIP/Postal Code
11553
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Garrett Nash, MD
Phone
212-639-8668
Facility Name
Allegheny Health Network (Data Collection Only)
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick Wagner, MD
Phone
833-246-7662

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Links:
URL
http://www.mskcc.org
Description
Memorial Sloan Kettering Cancer Center

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A Study of Additional Chemotherapy After Surgery for People With Malignant Peritoneal Mesothelioma

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