Phase I Trial HIPEC With Nal-irinotecan

Inclusion Criteria

• •1. 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.
• •2. Age ≥18 years
• •3. Eastern Cooperative Oncology Group performance status of 0 or 1
• •4. Patients must be candidates for grossly complete cytoreduction surgery with life expectancy greater than 3 months
• •5. 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
• •6. 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.
• •7. 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.
• •8. Ability to understand and the willingness to sign a written informed consent document.