Actively Recruiting
PIPAC for the Treatment of Peritoneal Carcinomatosis in Patients With Ovarian, Uterine, Appendiceal, Colorectal, or Gastric Cancer
Led by City of Hope Medical Center · Updated on 2025-12-10
49
Participants Needed
3
Research Sites
384 weeks
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase I trial studies the side effects of pressurized intraperitoneal aerosol chemotherapy (PIPAC) in treating patients with ovarian, uterine, appendiceal, stomach (gastric), or colorectal cancer that has spread to the lining of the abdominal cavity (peritoneal carcinomatosis). Chemotherapy drugs, such as cisplatin, doxorubicin, oxaliplatin, leucovorin, fluorouracil, mitomycin, and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. PIPAC is a minimally invasive procedure that involves the administration of intraperitoneal chemotherapy. The study device consists of a nebulizer (a device that turns liquids into a fine mist), which is connected to a high-pressure injector, and inserted into the abdomen (part of the body that contains the digestive organs) during a laparoscopic procedure (a surgery using small incisions to introduce air and to insert a camera and other instruments in the abdominal cavity for diagnosis and/or to perform routine surgical procedures). Pressurization of the liquid chemotherapy through the study device results in aerosolization (a fine mist or spray) of the chemotherapy intra-abdominally (into the abdomen). Giving chemotherapy through PIPAC may reduce the amount of chemotherapy needed to achieve acceptable drug concentration, and therefore potentially reduces side effects and toxicities.
CONDITIONS
Official Title
PIPAC for the Treatment of Peritoneal Carcinomatosis in Patients With Ovarian, Uterine, Appendiceal, Colorectal, or Gastric Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided documented informed consent
- Have histologically confirmed ovarian, uterine, gastric, appendiceal, or colorectal cancer with peritoneal carcinomatosis
- Prior intraperitoneal chemotherapy allowed
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Absolute neutrophil count of at least 1500/mm^3
- Platelet count of at least 100,000/mm^3
- Hemoglobin level of at least 9 g/dl
- Serum total bilirubin less than or equal to 1.5 times the upper limit of normal
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to 2.5 times upper limit of normal unless liver metastases or chronic liver disease present, then up to 5 times normal
- Alkaline phosphatase less than or equal to 2 times upper limit of normal
- Serum creatinine less than or equal to 1.5 times upper limit of normal or creatinine clearance of at least 40 ml/min
- No contraindications for laparoscopy
- Visible peritoneal disease on imaging or laparoscopy
- Disease progression on at least one prior chemotherapy regimen (for Arms 1 and 2)
- Stable or responsive disease on at least 4 months first-line chemotherapy (for Arm 3)
- Hepatitis B viral load undetectable if history of chronic hepatitis B
- Hepatitis C treated and cured or currently undetectable viral load if on treatment
- Women of childbearing potential and male partners must use effective contraception during and for 12 weeks after treatment
- Laparoscopy must confirm feasibility of PIPAC access, room for aerosol therapy, no impending bowel obstruction, less than or equal to 5 liters of ascites, and not a candidate for cytoreduction and HIPEC
You will not qualify if you...
- Presence of extra-peritoneal metastatic disease (gastric and colorectal/appendiceal cancers)
- Prior maximum cumulative doses of anthracyclines (such as doxorubicin) for ovarian, uterine, or gastric cancers (Arm 1)
- Known dihydropyrimidine dehydrogenase (DPD) deficiency (Arm 2 and 3)
- Bowel obstruction requiring nasogastric tube, feeding tube, or exclusive total parenteral nutrition (Arm 2 and 3)
- Prior severe allergic reaction to platinum-based chemotherapy (Arm 2)
- Unrecovered adverse events from prior anti-cancer therapy above grade 1 except alopecia, hearing loss, or minor lab abnormalities; grade 2 peripheral neuropathy allowed (Arm 2 and 3)
- Life expectancy less than 6 months (Arm 2 and 3)
- Chemotherapy or surgery within 4 weeks prior to enrollment (6 weeks for bevacizumab) for Arm 2; within 2 weeks for Arm 3
- Previous anaphylactic reaction to chemotherapy drugs used
- Receiving other investigational or concurrent anti-cancer agents
- Ascites due to decompensated liver cirrhosis or portal vein thrombosis
- Simultaneous tumor debulking with gastrointestinal resection
- Uncontrolled illness including active infection, severe heart failure, recent heart attack, severe arrhythmias, severe kidney or liver impairment, or myelosuppression
- Immunocompromised status due to medication or disease
- Involvement in planning or conduct of this study
- Pregnancy
- Psychiatric or social issues limiting compliance
- New York Heart Association class 3 or 4 heart disease, recent diabetes with ketoacidosis, or severe lung disease requiring hospitalization in past 6 months
- Major systemic infection needing antibiotics within 72 hours before study drug
- Prior intra-abdominal aerosol chemotherapy (Arm 2 and 3)
AI-Screening
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Trial Site Locations
Total: 3 locations
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
2
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
Actively Recruiting
3
Northwell Health Cancer Institute at Huntington
Greenlawn, New York, United States, 11740
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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