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

  • STATUS
    Recruiting
  • End date
    Dec 30, 2031
  • participants needed
    60
  • sponsor
    National Cancer Institute (NCI)
Updated on 22 September 2021
absolute neutrophil count
doxorubicin
oxaliplatin
neutrophil count
EGFR
mitomycin
cancer chemotherapy
antineoplastic
5-fluorouracil
cytoreductive surgery
intraperitoneal chemotherapy
cytoreduction

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 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.

Description

Background

Peritoneal carcinomatosis is uniformly fatal if untreated; improved outcomes are seen with aggressive cytoreductive surgery (CRS) and heated intraperitoneal chemotherapy (HIPEC).

The selection of chemotherapeutic agent for HIPEC is largely based on primary tumor histology and provider preference as opposed to knowledge of the potential efficacy of a specific agent for an individual patient.

HIPEC is intended to target small or microscopic residual disease following complete cytoreduction; however, the actual efficacy and additional benefit of HIPEC is in question.

The SMART System provides an ideal platform upon which to perfuse small peritoneal tumor tissue implants and simulate HIPEC treatment ex vivo.

Tissue response to simulated ex vivo HIPEC treatment in the SMART System could inform chemotherapeutic agent selection for subsequent cytoreduction and intra-operative in vivo HIPEC treatments.

Objective

To determine the correlation between ex vivo simulated HIPEC in the SMART System and in vivo HIPEC with respect to two measures of response to treatment: percent necrosis and Ki-67

Eligibility

Histologically confirmed peritoneal carcinomatosis from appendiceal, colorectal, ovarian, or peritoneal mesothelioma histologies

Absence of extra-abdominal metastatic disease

Participant deemed able to undergo complete cytoreduction

Age >= 18 years of age

Design

This is a Phase I study of cytoreductive surgery (CRS) and heated intraperitoneal chemotherapy (HIPEC), with randomization to one of two accepted HIPEC treatment regimens as determined by primary histology.

At the time of cytoreduction, representative peritoneal tumor biopsies will be obtained before and after intra-operative in vivo HIPEC treatment.

Tumor nodules harvested before intra-operative HIPEC will be placed in the SMART System, exposed to simulated ex vivo HIPEC treatment, and then perfused, with subsequent assessment of percent necrosis and Ki-67.

Tumor nodules harvested after intra-operative HIPEC will be placed in the SMART System and perfused, with subsequent assessment of percent necrosis and Ki-67.

The correlation of percent necrosis and Ki-67 assessment following simulated ex vivo HIPEC and intra-operative in vivo HIPEC will be determined.

Details
Condition Gastrointestinal Neoplasm, Ovarian disorder, Abdominal Neoplasm, Ovarian Cancer, GASTROINTESTINAL DISORDER, Neoplasm of unspecified nature of digestive system, Malignant neoplasm of appendix, Peritoneal Carcinomatosis, Peritoneal Mesothelioma, gastrointestinal cancer, ovarian carcinomas, cancer, ovarian, cancer ovarian, cancer of the ovary, ovarian tumors, gastrointestinal cancers
Treatment cisplatin, Oxaliplatin, doxorubicin, Sodium Thiosulfate, 5-fluorouracil, Mitomycin C, Heated Intraperitonial Chemotherapy
Clinical Study IdentifierNCT04847063
SponsorNational Cancer Institute (NCI)
Last Modified on22 September 2021

Eligibility

Yes No Not Sure

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 PCI score >= 30 at the time of laparoscopy
Age >= 18 years
ECOG performance status <= 1 (Karnofsky >= 80%)
Participants must have adequate organ and marrow function as defined below
Leukocytes >= 3,000/mcL
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)
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, women of childbearing potential and men 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; should a woman suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
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
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 deificiency (appendiceal or colorectal
cancer patients only)
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 women are excluded from this study because the protocol involves major abdominal surgery and chemotherapeutic agents with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother, breastfeeding should be discontinued if the mother is undergoing treatment
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
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