PIPAC Clinical Trial Offers Investigational Option for Patients with Unresectable Peritoneal Metastases

Patients with gastrointestinal cancers that have spread to the peritoneum can face limited treatment options when the extent or location of disease makes cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS/HIPEC) unfeasible. Pressurized intraperitoneal aerosolized chemotherapy (PIPAC) is a novel approach to delivery chemotherapy directly into the peritoneal cavity.

Evaluating PIPAC for Unresectable Peritoneal Disease

Surgical oncologists Sean Dineen, M.D., and Michael Wach, M.D., specialize in peritoneal surface malignancies and advanced treatments such as cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (HIPEC). Led by principal investigator Dr. Dineen, Clinical Trial MCC 23064 is a Phase I study evaluating pressurized intraperitoneal aerosol chemotherapy (PIPAC) with mitomycin C for patients with unresectable peritoneal disease from colorectal, high-grade appendiceal or small bowel cancers. We have assembled a team that specializes in the treatment of peritoneal disease. Moffitt is among a select group of U.S. centers with access to PIPAC, and the study is assessing its safety and tolerability while establishing a recommended dose for future studies.

PIPAC represents a promising area of investigation for patients with unresectable peritoneal metastases who may have limited treatment options. Through this trial, we are evaluating whether this targeted approach can be delivered safely while laying the groundwork for future studies.
-Dr. Sean Dineen

Expanding Treatment Options Beyond CRS/HIPEC

For select patients with gastrointestinal cancers that have spread to the peritoneum, CRS/HIPEC may be considered. Cytoreductive surgery removes visible disease, followed by HIPEC to deliver heated chemotherapy directly into the abdominal cavity to treat microscopic disease that may remain.

This approach depends on the ability to achieve complete cytoreduction. Patients with extensive peritoneal disease, significant small bowel involvement or disease involving critical structures may not be candidates for CRS/HIPEC.

PIPAC is being investigated as a regional treatment approach for this patient population who are not good candidates for cytoreductive surgery. PIPAC may help control peritoneal tumor burden and alleviate symptoms related to progressive disease, including abdominal pain, pressure, bloating, ascites and other cancer-related symptoms. For most patients, the goal of treatment is therefore symptom control, preservation of quality of life and potentially slowing disease progression, rather than cure or subsequent surgical resection.

This trial is specifically evaluating its use in patients with unresectable peritoneal disease.

Delivering Chemotherapy Directly to the Peritoneum

PIPAC is performed during a minimally invasive laparoscopic procedure. Mitomycin C is converted into a fine aerosol and delivered under pressure directly into the abdominal cavity. The approach is designed to distribute chemotherapy throughout the peritoneal cavity and facilitate penetration into tumor tissue.

Patients enrolled in the study may receive up to three PIPAC procedures at eight-week intervals while continuing 5-fluorouracil and leucovorin between procedures.

As a Phase I study, the trial is primarily evaluating the safety and tolerability of PIPAC with mitomycin C and determining a recommended Phase II dose. Researchers will also assess pharmacokinetics, pharmacodynamics, quality of life and histologic changes in tumor tissue following treatment.

When to Consider a Clinical Trial Referral

Referral may be appropriate for patients with histologically confirmed peritoneal disease from colorectal, small bowel or high-grade appendiceal adenocarcinoma. Eligible high-grade appendiceal cancers may include select mucinous, non-mucinous, signet ring cell and goblet cell adenocarcinomas.

Potential candidates must be 18 or older, have an ECOG performance status of 0 or 1 and have completed at least four months of first-line 5-FU-based systemic therapy, with or without biologic therapy.

Patients must also be ineligible for CRS/HIPEC because of factors such as disease burden, inability to achieve complete cytoreduction, significant small bowel involvement or unresectable disease involving critical structures. Patients who decline invasive cytoreduction may also be considered.

Additional eligibility requirements apply. can help determine whether the study is appropriate for an individual patient.

Expanding Access to an Investigational Approach

PIPAC remains investigational and is available at a limited number of specialized centers in the United States. For patients with gastrointestinal cancers involving the peritoneum who are not candidates for CRS/HIPEC, Clinical Trial MCC 23064 provides an opportunity to be evaluated for this emerging approach.

Clinical Trial MCC 23064

Phase: I

Principal Investigator: Sean Dineen, M.D.

For referral or clinical trial information: 813-937-6752 or 1-844-662-3142