Gender
All
Age Group
18 Years and up
Accepting Healthy Volunteers
No
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.