Phase I trial of Cytoreductive Surgery and Heated Intraperitoneal Chemotherapy with Nanoliposomal Irinotecan in Patients with Peritoneal Surface Cancers

Principal Investigators: Choi, Minsig; Kim, Joseph Current Status: OPEN TO ACCURAL
Phase: I Protocol Type: Treatment
Coordinator: Caravella, Giuseppinabr />
(631) 216-2967
Sponsor Type: Institutional
Disease Group: Gastrointestinal

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. Clinical diagnosis is required prior to surgery and pathologic diagnosis of peritoneal surface disease must be confirmed from surgical pathology.

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 measurable disease by radiographic peritoneal carcinomatosis index (PCI) score and RECIST criteria with preoperative measurements taken within 4 weeks of study entry. Presence of measurable disease is required for entry into this study.
  • 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.