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Chemotherapy for Mesothelioma

Phase 2

Recruiting

Led By Garrett Nash, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Complete or near-complete CRS achieved

ECOG performance status ≤ 1

Must not have

Subjects with preoperative or intraoperative biopsy consistent with sarcomatoid mesothelioma, well-differentiated papillary mesothelioma, or benign multicystic mesothelioma

Women who are pregnant or lactating

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial compares intraperitoneal vs. intravenous chemotherapy to determine which is more effective for people with mesothelioma.

Who is the study for?

This trial is for adults with malignant peritoneal mesothelioma who've had surgery to remove most of the cancer. They need good liver and kidney function, no severe unrelated medical issues, not pregnant or breastfeeding, and can't have used certain chemotherapies before.

What is being tested?

The study tests if chemotherapy given directly into the abdomen (intraperitoneal) or through a vein (intravenous) after surgery helps patients more. It compares these two methods post-surgery to see which one might be more effective.

What are the potential side effects?

Chemotherapy drugs like Carboplatin, Pemetrexed, and Cisplatin may cause nausea, fatigue, kidney problems, allergic reactions, blood cell count changes leading to increased infection risk or bleeding complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My surgery removed almost all of my cancer.

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I am fully active and can carry on all my pre-disease activities without restriction.

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My mesothelioma was confirmed to be epithelioid type during surgery.

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I have been diagnosed with MPM at this hospital.

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I am scheduled for surgery to remove all cancer from my abdomen.

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My kidney function is within the normal range.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My biopsy shows I have a specific type of mesothelioma.

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I am currently pregnant or breastfeeding.

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My blood pressure is higher than 140/90 and I'm not cleared for surgery.

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I have heart failure or lung disease that could affect my participation in the study.

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I am allergic to cisplatin, carboplatin, pemetrexed, or mitomycin.

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My doctors suspect my cancer has spread outside my abdomen.

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My surgeon found extensive scar tissue in my abdomen that prevents certain treatments.

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I have had chemotherapy for peritoneal mesothelioma.

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I do not have a history of stroke or brain blood vessel issues that would make it unsafe for me to join the study.

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I have been treated with platinum-based chemotherapy before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression Free Survival

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: IVC armExperimental Treatment3 Interventions

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.

Group II: NIPC armActive Control3 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pemetrexed

2014

Completed Phase 3

~5550

Cisplatin

2013

Completed Phase 3

~3120