Study on Pressurized Intraperitoneal Aerosolized Chemotherapy with Mitomycin for Treating Unremovable Appendix or Colorectal Cancer with Abdominal Spread

Sponsor: City of Hope Medical Center

Sponsor score: 40

ClinicalTrials ID:NCT07271355

Provider View

This clinical trial is testing a new method of delivering chemotherapy directly into the abdomen as a mist to treat appendix or colorectal cancer that cannot be surgically removed and has spread to the abdominal area. The study compares this new method with standard chemotherapy treatments.

Patient Parameters

Program Overview

This study is exploring a new way to treat appendix or colorectal cancer that has spread to the abdomen and cannot be removed by surgery. The treatment involves delivering chemotherapy as a pressurized mist directly into the abdominal cavity, which may help the medication absorb better into cancer tissues. This method is compared to the standard chemotherapy given through a vein, which includes drugs like leucovorin, fluorouracil, irinotecan, and bevacizumab. The goal is to see if this new approach can improve treatment outcomes for patients.

Description

The main goal of this study is to see if using mitomycin as a pressurized mist inside the abdomen, along with standard chemotherapy, can help patients with appendix or colorectal cancer live longer compared to standard chemotherapy alone. The study will also look at how long patients live without the cancer getting worse, how well the cancer responds to treatment, and the quality of life of patients during and after treatment.

Patients will be randomly assigned to one of two groups:

  • Group 1: Patients will receive mitomycin as a mist inside the abdomen every 6 weeks for up to 3 cycles, along with standard chemotherapy (FOLFIRI) every 2 weeks. After the last mist treatment, they may also receive bevacizumab every 2 weeks.

  • Group 2: Patients will receive standard chemotherapy (FOLFIRI) every 2 weeks and bevacizumab every 2 weeks after a standard laparoscopy.

Patients will undergo regular scans and tests to monitor their health and the cancer's response to treatment. After completing the study treatment, patients will have follow-up visits every 8-12 weeks.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of appendix or colorectal cancer that has spread to the abdomen.
  • No cancer spread outside the abdomen, except for up to 5 small lung lesions.
  • Have completed at least 4 months of initial chemotherapy without the cancer getting worse.
  • Not eligible for surgery to remove the cancer.
  • Be in good overall health with specific blood counts and organ function.
  • Women of childbearing potential must have a negative pregnancy test and agree to use birth control during the study and for 14 months after.
  • Agree to provide tissue samples for research purposes.

Exclusion Criteria

  • Have received more than 8 cycles of irinotecan therapy.
  • Cancer has progressed on irinotecan.
  • Have received any second-line chemotherapy.
  • Currently receiving other cancer treatments.
  • Have certain medical conditions or infections that could interfere with the study.
  • Have a history of severe allergic reactions to similar drugs.
  • Women who are pregnant or breastfeeding.
  • Any condition that would make participation unsafe or difficult according to the study doctor.

Locations

FACILITYZIPCITYSTATE
CTCA at Western Regional Medical Center85338GoodyearArizona
City of Hope Comprehensive Cancer Center91010DuarteCalifornia
City of Hope at Irvine Lennar92618IrvineCalifornia
City of Hope Atlanta Cancer Center30265NewnanGeorgia
City of Hope at Chicago60099ZionIllinois

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