Individualized Response Assessment to Heated Intraperitoneal Chemotherapy (HIPEC) for the Treatment of Peritoneal Carcinomatosis From Ovarian, Colorectal, Appendiceal, or Peritoneal Mesothelioma Histologies

Launched by NATIONAL CANCER INSTITUTE (NCI) · Apr 14, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a treatment approach for patients with peritoneal carcinomatosis, which occurs when cancer spreads to the lining of the abdomen from cancers like ovarian, colorectal, appendiceal, or peritoneal mesothelioma. The goal is to see if using different chemotherapy drugs during a procedure called Heated Intraperitoneal Chemotherapy (HIPEC) can improve outcomes after a surgery that removes visible tumors (called cytoreductive surgery or CRS). Researchers will use a special system to test the best chemotherapy options tailored to each patient.

To join the trial, participants must be adults (18 years or older) with peritoneal carcinomatosis that can't be completely removed by surgery. They should be in good health overall and meet specific medical criteria. Participants will undergo screening tests, have their tumors surgically removed, and receive HIPEC treatment, which involves delivering heated chemotherapy directly into the abdomen. They will stay in the hospital for about a week or more after the procedure and will provide samples for research and complete surveys about their health. Regular follow-up visits will occur for up to five years to monitor their progress and well-being.

Gender

ALL

Eligibility criteria

• * INCLUSION CRITERIA:
• • Confirmation of peritoneal carcinomatosis from appendiceal, colorectal, ovarian, or peritoneal mesothelioma histologies by the Laboratory of Pathology, NCI.
• • Measurable or evaluable disease as defined by RECIST v1.1. criteria and/or by peritoneal carcinomatosis index (PCI) score.
• * Participants must be assessed to be able to undergo complete cytoreduction, with laparoscopically assessed PCI score thresholds as indicated below:
• • Primary Histology: Appendiceal/Colorectal/Ovarian / PCI Cutoff for Eligibility: Total Score \< 20 (out of 39 possible points)
• • Primary Histology: Mesothelioma / PCI Cutoff for Eligibility: Total Score \<= 30 (out of 39 possible points)
• • Age \>= 18 years.
• • ECOG performance status \<= 1 (Karnofsky \>= 80%).
• * Participants must have adequate organ and marrow function as defined below:
• • Absolute neutrophil count \>= 1,000/mcL
• • Platelets \>= 75,000/mcL
• • Total bilirubin within normal institutional limits
• • AST (SGOT)/ ALT (SGPT) \<= 3x institutional upper limit of normal (ULN), or \<= 5.0x ULN in participants with liver metastases (only)
• • Creatinine within normal institutional limits
• • OR
• • --Creatinine clearance \>= 60 mL/min/1.73 m\^2 for participants with creatinine levels above institutional normal calculated using eGFR.
• • Because therapeutic agents used in this trial are known to be teratogenic, individuals of child-bearing potential (IOCBP) and individuals who are able to father a child must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for 180 days after last study treatment.
• • Ability of participant to understand and the willingness to sign a written informed consent document.
• • Ability and willingness to co-enroll on the tissue collection protocol 13C0176, Tumor, Normal Tissue and Specimens from Patients Undergoing Evaluation or Surgical Resection of Solid Tumors .
• EXCLUSION CRITERIA:
• • Participants with known extra-abdominal metastatic disease from the participant s appendiceal, colorectal, ovarian, or peritoneal mesothelioma primary.
• • Participants who have received intraperitoneal chemotherapy or other anti-cancer therapy within the last 4 weeks prior to the start of study treatment.
• • Participants who have undergone major surgery within the last 12 weeks prior to the start of study treatment.
• • History of allergic reactions attributed to platinum-containing compounds.
• • History of dihydropyrimidine dehydrogenase deficiency (only participants with appendiceal or colorectal cancer).
• • Uncontrolled intercurrent 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.
• • Pregnant individuals are excluded from this study because the protocol involves major abdominal surgery and chemotherapeutic agents with the potential for teratogenic or abortifacient effects. Note: Due to an unknown but potential risk for adverse events in nursing infants secondary to treatment of the participant, nursing (including breastfeeding) should be discontinued if the participant is undergoing treatment (i.e., nursing participants must agree to discontinue nursing activities).
• • HIV-positive participants with detectable viral load despite antiretroviral therapy are ineligible because of participants increased risk of lethal infections when treated with marrow-suppressive therapy. HIV-positive participants who have undetectable viral load on antiretroviral therapy may be considered for this study only after consultation with a NIAID physician.