Status:
RECRUITING
Individualized Response Assessment to Heated Intraperitoneal Chemotherapy (HIPEC) for the Treatment of Peritoneal Carcinomatosis From Ovarian, Colorectal, Appendiceal, or Peritoneal Mesothelioma Histologies
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Peritoneal Carcinomatosis
Peritoneal Mesothelioma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 tu...
Detailed Description
Background: Peritoneal carcinomatosis is uniformly fatal if untreated; improved outcomes are seen with aggressive cytoreductive surgery (CRS) and heated intraperitoneal chemotherapy (HIPEC). The sel...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
October 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2031
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04847063
Start Date
October 19 2021
End Date
December 30 2031
Last Update
December 4 2025
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892