Pressurized aerosol chemotherapy (PIPAC) for pancreatic cancer that has spread to the peritoneum

Phase I Trial of Pressurized Intraperitoneal Aerosolized Chemotherapy (PIPAC) in Patients With Peritoneal Metastasis From Pancreatic Adenocarcinoma

This will try PIPAC (pressurized intraperitoneal aerosolized chemotherapy) with nab-paclitaxel in adults whose pancreatic adenocarcinoma has spread to the lining of the abdomen to see if it improves drug delivery and clinical outcomes.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Northwell Health (Academic / other)
• Drugs / interventions: chemotherapy, doxorubicin
• Locations: 1 site (New Hyde Park, New York)
• Trial ID: NCT07253662 on ClinicalTrials.gov

What this trial studies

This phase 1 interventional trial delivers low-dose chemotherapy as a pressurized aerosol (PIPAC) to the peritoneal cavity via laparoscopy in adults with pancreatic adenocarcinoma and peritoneal metastasis. The approach is intended to maximize local drug concentration and tissue penetration while minimizing systemic exposure, using nab-paclitaxel as the agent. Enrolled patients must have visible peritoneal disease, ECOG performance status of 0-2, and adequate organ function to undergo laparoscopy and chemotherapy. The study will focus on safety, tolerability, dose parameters, and preliminary signals of clinical or symptomatic benefit.

Who should consider this trial

Good fit: Adults (≥18) with histologically confirmed pancreatic adenocarcinoma and visible or biopsy-proven peritoneal metastasis, ECOG ≤2, adequate blood counts and organ function, and no contraindication to laparoscopy are ideal candidates.

Not a fit: Patients with widespread non-peritoneal metastases, poor performance status (ECOG >2), significant organ dysfunction, uncontrolled comorbidity, or who cannot undergo laparoscopy are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, this approach could deliver more chemotherapy directly to peritoneal tumor implants with lower systemic toxicity, potentially improving symptom control and survival.

How similar studies have performed: Early-phase and nonrandomized series of PIPAC in various cancers with peritoneal metastasis have shown feasibility and occasional tumor responses, but randomized evidence in pancreatic peritoneal metastasis is lacking.

Eligibility criteria

Inclusion Criteria:

* Ability to understand and sign informed consent form
* Age ≥18 years
* Patient must have histologically confirmed pancreatic adenocarcinoma with either histologic confirmation or strong suspicion of peritoneal metastasis on cross sectional imaging
* ECOG performance status ≤ 2
* Pre-treatment Laboratory Parameters:
* Absolute neutrophil count (ANC) \> 1500/mm3
* Platelets \> 100,000/mm3
* Hemoglobin \> 9 g/dl
* Serum total bilirubin \< 1.5 x upper limit of normal (ULN)
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 2.5 x ULN, unless patient is known to have chronic liver disease (hepatitis) in which case AST and ALT must be ≤ 5 x ULN.
* Creatinine clearance (Ccr) \> 40 ml/min

  * No contraindications for a laparoscopy.
* The peritoneal disease does not have to be measurable by RECIST 1.1 but needs to visible on cross sectional imaging or diagnostic laparoscopy.
* For patients with a known history of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
* Patients with a known history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
* Women of childbearing potential (WOCBP) and male patients with WOCBP partner must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 6 months after the PIPAC or last dose of chemotherapy in such a manner that the risk of pregnancy is minimized .-WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal. Post menopause is defined as:

Amenorrhea ≥ 12 consecutive months without another cause or For women with irregular menstrual periods and on hormone replacement therapy (HRT), a documented serum follicle stimulating hormone (FSH) level \> 35 mIU/mL Women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where their partner is sterile (e.g., vasectomy) should be considered of childbearing potential.

Inclusion to proceed with PIPAC :

Laparoscopy findings must meet all of the below criteria in order to proceed to PIPAC:

* PIPAC access is feasible
* There is room for aerosol therapy
* There is no evidence of impending bowel obstruction
* \< 5 L of ascites
* Not a candidate for cytoreduction and HIPEC

Exclusion Criteria:

* Confirmed or suspected extra-peritoneal metastasis
* Bowel obstruction requiring nasogastric tube, percutaneous endoscopic gastrostomy or exclusive total parenteral nutrition.
* Life expectancy of less than 4 months.
* Prior intra-abdominal aerosol chemotherapy
* Previous anaphylactic reaction to the nab-paclitaxel drug used.
* Intra-abdominal Ascites \>5L
* Patients may not be receiving any other investigational agents.
* Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, severe myocardial insufficiency, recent myocardial infarction, severe arrhythmias, severe renal impairment, myelosuppression, or severe hepatic impairment.
* Immunocompromised patients such as those with an immunosuppressive medication or a known disease of the immune system.
* New York Heart Association (NYHA) Class 3 or 4; myocardial infarction, acute coronary syndrome, diabetes mellitus with ketoacidosis or chronic obstructive pulmonary disease (COPD) requiring hospitalization in the preceding 6 months.
* Exclusive total parenteral nutrition.
* Pregnancy. Patients with psychiatric illness/social situations that would limit compliance with study requirements.

Where this trial is running

New Hyde Park, New York

• Zuckerberg Cancer Center — New Hyde Park, New York, United States (Recruiting)

Study contacts

• Study coordinator: GI Trial Referral Team

Conditions Adenocarcinoma Pancreas