Individualized Response Assessment to Heated Intraperitoneal Chemotherapy (HIPEC) for the Treatment of Peritoneal Carcinomatosis From Ovarian, Colorectal, Appendiceal, or Peritoneal Mesothelioma Histologies
Background: Cytoreductive surgery (CRS) removes tumors in the abdomen. HIPEC is heated chemotherapy that washes the abdomen. CRS and HIPEC may help people with peritoneal carcinomatosis. These are tumors that have spread to the lining of the abdomen from other cancers. Researchers think they can improve results of CRS and HIPEC by choosing the chemotherapy drugs used in HIPEC.
Objective: To see if HIPEC after CRS can be improved, by testing different chemotherapy drugs, using a model called the SMART (Sample Microenvironment of Resected Metastatic Tumor) System.
Eligibility: Adults ages 18 and older who have peritoneal carcinomatosis that cannot be fully removed safely with surgery.
Design: Participants will be screened with: Medical history Physical exam Blood and urine tests Computed tomography (CAT) scan Other imaging scans, as needed Electrocardiogram (EKG) Tumor biopsy, if needed Laparoscopy. Small cuts will be made in the abdomen. A tube with a light and a camera will be used to see their organs. Some screening tests will be repeated in the study. Participants will enroll in NIH protocol #13C0176. This allows their tumor samples to be used in future research. Participants will have CRS. As many of their visible tumors will be removed as possible. They will also have HIPEC. Two thin tubes will be put in their abdomen. They will get chemotherapy through one tube. It will be drained out through the other tube. They will be in the hospital for 7-21 days after surgery. Participants will give tumor, blood, and fluid samples for research. They will complete surveys about their health and quality of life. Participants will have follow-up visits over 5 years.
⁃ 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 .