RecruitingPhase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study is for adults with malignant peritoneal mesothelioma, a cancer in the lining of the belly. It compares chemotherapy given into the belly with chemotherapy given into a vein after surgery to remove the cancer and heated chemotherapy in the belly (HIPEC). The goal is to find out whether one treatment works better than the other.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older.
  • Have peritoneal mesothelioma diagnosed at the study center. Tissue tested during surgery must confirm the epithelioid type.
  • Plan to have all cancer in the belly lining removed by surgery. All or nearly all of it must be removed.
  • Be fully active or able to do light work despite some limits on hard physical activity.
  • Have enough infection-fighting white blood cells (at least 1,500/µl) and platelets, which help blood clot (more than 75,000/µl).
  • Meet the study's kidney and liver blood test limits. A different liver test limit applies to people with Gilbert's syndrome.
  • If able to become pregnant, have a negative pregnancy test and use effective birth control from screening through the study. Men must use reliable barrier birth control during the study.
  • Sign and date a consent form before any study procedures.

Who can't join

  • Past chemotherapy into the belly, or chemotherapy or immune treatment throughout the body, for peritoneal mesothelioma; or any past platinum-based chemotherapy.
  • Tissue tests show sarcomatoid, well-differentiated papillary, or benign multicystic mesothelioma rather than the required type.
  • A past cancer, unless it meets the study's exceptions for certain cured, treated, or slow-growing cancers; or strong signs that cancer has spread outside the belly.
  • Pregnant or breastfeeding, or expected to live less than 12 weeks.
  • Active disease in the heart's blood vessels without the required heart clearance; blood pressure above 140/90 without surgery clearance; or heart failure rated class II or higher.
  • Lung disease, a history of disease in the brain's blood vessels, or another serious health problem that makes study participation unsafe or hard to complete.
  • An allergy to cisplatin, carboplatin, pemetrexed, or mitomycin; or scar tissue inside the belly or another condition that prevents chemotherapy into the belly.
  • Need a medicine taken by mouth that cannot safely be stopped for up to 10 days and has no suitable substitute given another way.

Simplified for readability. The official criteria below are what the study team uses.

Official 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/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. * 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.

Study sites (13)

IL

MI

MO

NE

NJ

NY

PA