PIPAC with Mitomycin for Abdominal Cancer

This trial tests a new method of delivering chemotherapy directly into the abdomen using a spray form of mitomycin C. The researchers aim to determine the safety of this method and identify the optimal dose for treating abdominal cancer that cannot be surgically removed, specifically from the colon, appendix, or small bowel. Individuals with these cancers who have completed at least four months of first-line treatment and can safely undergo minor surgery may qualify. The study will also assess the treatment's impact on quality of life and how the body processes the drug. As a Phase 1 trial, the research focuses on understanding the treatment's effects in people, offering participants the chance to be among the first to receive this innovative approach.

The trial requires that you continue taking 5-fluorouracil/leucovorin (5-FU/LV) between procedures. If you are on other medications, the protocol does not specify if you need to stop them, but you should discuss this with the trial team.

Research has shown that pressurized intraperitoneal aerosol chemotherapy (PIPAC) with mitomycin C is generally safe for treating cancer that has spread to the abdominal lining. Studies have found that PIPAC with mitomycin C is well-tolerated and has a good safety record.

For instance, one study found that combining PIPAC-MMC with standard chemotherapy is safe and manageable, allowing patients to undergo treatment without severe side effects. Another study concluded that PIPAC is safe and can improve quality of life while reducing tumor size.

Unlike the standard treatments for abdominal cancer, which often involve systemic chemotherapy, Mitomycin C in this trial is delivered directly to the tumor site using a method called PIPAC (Pressurized Intraperitoneal Aerosol Chemotherapy). This innovative delivery system allows for higher concentrations of the drug to reach the cancer cells with potentially fewer side effects. Researchers are excited about this approach because it could enhance the effectiveness of the treatment while minimizing harm to healthy tissue. Plus, the dose escalation model used in this study aims to optimize the balance between efficacy and safety for each patient.

Research has shown that PIPAC with mitomycin C may help treat abdominal cancer. In studies, many patients experienced tumor reduction or initial shrinkage. One study found that patients lived for about 8 months on average after treatment. Another report indicated that survival could reach up to 16.4 months with similar treatments. In this trial, participants will receive PIPAC with mitomycin C, with dose escalation occurring via sequential cohorts. These findings suggest that PIPAC with mitomycin C might be effective for patients with peritoneal carcinomatosis, a type of cancer that spreads in the abdomen.¹⁶⁷⁸⁹