Phase I Trial HIPEC With Nal-irinotecan

Inclusion Criteria

• Patients with pseudomyxoma peritonei or peritoneal carcinomatosis of digestive origin or primary peritoneum: appendiceal mucinous tumor or adenocarcinoma (including goblet cell cancer and signet ring cell cancer), colorectal cancer, gastric cancer, primary peritoneal adenocarcinoma, and mesothelioma; regardless of the number of prior treatment lines. Diagnosis of peritoneal metastasis to be confirmed via either clinical or histopathology assessment.
• Age ≥18 years
• Eastern Cooperative Oncology Group performance status of 0 or 1
• Patients must be candidates for grossly complete cytoreduction surgery with life expectancy greater than 3 months
• Patients must have normal organ and marrow function as defined below:
• absolute neutrophil count >1,500/microliter (mcL) and white blood cells > 4000/mm3
• platelets >75,000/microliters
• total bilirubin < 3x upper limit normal for institutional limits
• aspartate aminotransferase (AST) / Alanine aminotransferase (ALT) <2.5x institutional upper limit of normal
• creatinine within normal institutional limits
• Documentation of resectable disease extent by radiographic peritoneal carcinomatosis index (PCI) score or preoperative diagnostic surgery/laparoscopy with preoperative measurements taken within 6 weeks of study entry.
• Women of child-bearing potential and men must agree to use adequate contraception (barrier or hormonal plus barrier method of birth control; abstinence) prior to study entry and for the duration of study participation (at least first 6 months). Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

• Patients with peritoneal disease considered to be unresectable according to preoperative clinical criteria.
• Patients who undergo debulking for palliation with persistence of gross residual disease (complete of cytoreduction score 3, CC=3) will be ineligible for the study.
• Large burden visceral metastases or extra-abdominal metastases.
• Patients who have had radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. There is no limit on the number of prior lines of chemotherapy.
• Patients may not be receiving any other investigational agents.
• History of allergic reactions to nal-IRI or irinotecan. 7 Uncontrolled ongoing illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. 8 Pregnant or breast-feeding women are excluded from this study. 9 HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy.