PIPAC with Mitomycin for Abdominal Cancer

Overseen By Valentina Diaz Aranzazu

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Must be taking: 5-FU

Must not be taking: Targeted therapy, Immunotherapy

Disqualifiers: Brain metastases, Extensive liver disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 3

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This single-center, Phase 1 dose-escalation study will evaluate the safety, tolerability, and recommended Phase 2 dose (RP2D) of pressurized intraperitoneal aerosol chemotherapy with mitomycin C (PIPAC-MMC) for patients with unresectable peritoneal carcinomatosis from gastrointestinal primaries (colorectal, high-grade appendiceal, or small bowel). Up to three PIPAC procedures are planned at 8-week intervals while patients continue 5-fluorouracil/leucovorin (5-FU/LV) between procedures. The trial uses a Bayesian optimal interval (BOIN) design to determine dose-limiting toxicities (DLTs) and maximum tolerated dose (MTD). Pharmacokinetics (PK), pharmacodynamics (PD), and quality of life (QoL) will be assessed.

Who Is on the Research Team?

Sean Dineen, MD

Principal Investigator

Moffitt Cancer Center

Are You a Good Fit for This Trial?

Inclusion Criteria

I am fully active or have only minor limitations in daily activities.

My blood, liver, and kidney tests are within normal limits.

I have finished at least 4 months of first-line 5-FU based treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive up to three PIPAC procedures with mitomycin C at 8-week intervals while continuing 5-FU/LV treatment

24 weeks

3 visits (in-person) for PIPAC procedures

Follow-up

Participants are monitored for safety, effectiveness, and quality of life after treatment

Up to 24 months

What Are the Treatments Tested in This Trial?

Interventions

• Mitomycin C

How Is the Trial Designed?

Group I: Mitomycin C Dose Escalation Experimental Treatment 2 Interventions

All participants are assigned to receive PIPAC-MMC. Dose escalation occurs via sequential cohorts using the BOIN model. No participant changes dose once assigned; each receives up to three PIPAC procedures at their assigned dose level.

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials

576

Recruited

145,000+