Phase
Condition
Gastrointestinal Diseases And Disorders
Colorectal Cancer
Stomach Cancer
Treatment
Heated Intraperitonial Chemotherapy
Sodium Thiosulfate
5-Fluorouracil
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
INCLUSION CRITERIA:
Confirmation of peritoneal carcinomatosis from appendiceal, colorectal, ovarian, orperitoneal mesothelioma histologies by the Laboratory of Pathology, NCI.
Measurable or evaluable disease as defined by RECIST v1.1. criteria and/or byperitoneal carcinomatosis index (PCI) score.
Participants must be assessed to be able to undergo complete cytoreduction, withlaparoscopically 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 tofather a child must agree to use adequate contraception (hormonal or barrier methodof birth control; abstinence) prior to study entry and for 180 days after last studytreatment.
Ability of participant to understand and the willingness to sign a written informedconsent document.
Ability and willingness to co-enroll on the tissue collection protocol 13C0176,Tumor, Normal Tissue and Specimens from Patients Undergoing Evaluation or SurgicalResection of Solid Tumors .
Exclusion
EXCLUSION CRITERIA:
Participants with known extra-abdominal metastatic disease from the participant sappendiceal, colorectal, ovarian, or peritoneal mesothelioma primary.
Participants who have received intraperitoneal chemotherapy or other anti-cancertherapy 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 thestart of study treatment.
History of allergic reactions attributed to platinum-containing compounds.
History of dihydropyrimidine dehydrogenase deficiency (only participants withappendiceal or colorectal cancer).
Uncontrolled intercurrent illness including, but not limited to, ongoing or activeinfection, symptomatic congestive heart failure, unstable angina pectoris, cardiacarrhythmia, or psychiatric illness/social situations that would limit compliancewith study requirements.
Pregnant individuals are excluded from this study because the protocol involvesmajor abdominal surgery and chemotherapeutic agents with the potential forteratogenic or abortifacient effects. Note: Due to an unknown but potential risk foradverse events in nursing infants secondary to treatment of the participant, nursing (including breastfeeding) should be discontinued if the participant is undergoingtreatment (i.e., nursing participants must agree to discontinue nursing activities).
HIV-positive participants with detectable viral load despite antiretroviral therapyare ineligible because of participants increased risk of lethal infections whentreated with marrow-suppressive therapy. HIV-positive participants who haveundetectable viral load on antiretroviral therapy may be considered for this studyonly after consultation with a NIAID physician.
Study Design
Study Description
Connect with a study center
National Institutes of Health Clinical Center
Bethesda, Maryland 20892
United StatesActive - Recruiting
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