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Alkylating agents

HIPEC for Peritoneal Cancer

Phase 1
Recruiting
Led By Andrew M Blakely, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Must not have
History of allergic reactions attributed to platinum-containing compounds.
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up death or 5 years post-treatment
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing if different chemotherapy drugs used during HIPEC can improve outcomes for people with peritoneal carcinomatosis.

Who is the study for?
Adults over 18 with peritoneal carcinomatosis from ovarian, colorectal, appendiceal, or mesothelioma cancers that can't be fully removed by surgery. They must have good physical function and organ health, not received certain treatments recently, agree to use contraception and co-enroll in a tissue collection study.
What is being tested?
The trial is testing the effectiveness of heated chemotherapy (HIPEC) after tumor-removing surgery (CRS). Different chemo drugs are used based on a model called SMART System to see if they improve outcomes for patients with tumors spread within the abdomen lining.
What are the potential side effects?
Possible side effects include reactions to platinum-based drugs like Cisplatin or Doxorubicin such as nausea, kidney issues, hearing loss; blood count changes due to Mitomycin C; nerve damage from Oxaliplatin; mouth sores and diarrhea from 5-Fluorouracil.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer, originating from the appendix, colon, ovary, or peritoneum, has spread within the abdomen.
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My cancer's growth can be measured or evaluated.
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I am fully active and can carry on all pre-disease activities without restriction.
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My blood counts and liver/kidney functions are within normal ranges.
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My doctor believes I can have all visible cancer removed, with a PCI score of 30 or less.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am allergic to medications that contain platinum.
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I do not have any serious illnesses or social situations that would stop me from following the study's requirements.
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My cancer has spread beyond my abdomen from my appendix, colon, ovary, or the lining of my abdomen.
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I have a genetic deficiency related to my appendiceal or colorectal cancer.
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I am not pregnant or breastfeeding as the treatment involves major surgery and drugs that could harm a baby.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~death or 5 years post-treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and death or 5 years post-treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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
Secondary study objectives
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, separately within each cohort and arm subset, as well as within...
To estimate the peritoneal progression-free survival probability as a function of tissue response to ex vivo simulated HIPEC in the SMART System and in vivo HIPEC, as assessed by percent necrosis and Ki-67, in a preliminary fashion
To estimate the peritoneal progression-free survival probability, separately by arms and by cohorts, in a preliminary fashion
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: 4/ HIPEC: Cisplatin, Mitomycin C Randomized treatment assignmeExperimental Treatment4 Interventions
HIPEC with intraperitoneal cisplatin and mitomycin C, in addition to IV sodium thiosulfate, randomly assigned
Group II: 3/ HIPEC: Cisplatin, Doxorubicin Randomized treatment assignmeExperimental Treatment4 Interventions
HIPEC with intraperitoneal cisplatin and doxorubicin, in addition to IV sodium thiosulfate, randomly assigned
Group III: 2/ HIPEC: Mitomycin C Randomized treatment assignmentExperimental Treatment2 Interventions
HIPEC with intraperitoneal mitomycin C, randomly assigned
Group IV: 1/ HIPEC: Oxaliplatin Randomized treatment assignmentExperimental Treatment3 Interventions
HIPEC with intraperitoneal oxaliplatin and IV 5-FU, randomly assigned
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sodium Thiosulfate
2017
Completed Phase 3
~120
Cisplatin
2013
Completed Phase 3
~3120
Doxorubicin
2012
Completed Phase 3
~8030
Oxaliplatin
2011
Completed Phase 4
~2890
Mitomycin C
2019
Completed Phase 4
~840
5-Fluorouracil
2012
Completed Phase 3
~7800

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,928 Previous Clinical Trials
41,017,978 Total Patients Enrolled
Andrew M Blakely, M.D.Principal InvestigatorNational Cancer Institute (NCI)
3 Previous Clinical Trials
579 Total Patients Enrolled

Media Library

Cisplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT04847063 — Phase 1
Gastrointestinal Cancer Research Study Groups: 4/ HIPEC: Cisplatin, Mitomycin C Randomized treatment assignme, 3/ HIPEC: Cisplatin, Doxorubicin Randomized treatment assignme, 1/ HIPEC: Oxaliplatin Randomized treatment assignment, 2/ HIPEC: Mitomycin C Randomized treatment assignment
Gastrointestinal Cancer Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT04847063 — Phase 1
Cisplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04847063 — Phase 1
~40 spots leftby Dec 2030
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