Actively Recruiting
Safety and Efficacy of Pressurized Intraperitoneal Aerosolized Chemotherapy (PIPAC) in Ovarian, Uterine, Appendiceal, Colorectal, and Gastric Cancer Patients With Peritoneal Carcinomatosis
Led by City of Hope Medical Center · Updated on 2025-12-10
49
Participants Needed
3
Research Sites
N/A
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
Researchers are evaluating the safety and side effects of pressurized intraperitoneal aerosol chemotherapy (PIPAC) for patients with ovarian, uterine, appendiceal, colorectal, or gastric cancer that has spread to the lining of the abdominal cavity, known as peritoneal carcinomatosis. This phase I trial aims to identify the maximum tolerated dose of PIPAC with mitomycin in certain patients and assess its safety across different patient groups. The study also explores how well patients respond to PIPAC and monitors quality of life and functional status. Participants are assigned to one of four groups based on their cancer type and treatment history. Treatments involve PIPAC delivering chemotherapy drugs like doxorubicin, cisplatin, oxaliplatin, mitomycin, and combinations with intravenous drugs such as leucovorin, fluorouracil, and irinotecan. Each treatment cycle repeats every 4 to 6 weeks for up to three cycles unless disease progression or unacceptable side effects occur. A dose de-escalation plan is in place if initial doses are not tolerated. During the study, patients undergo biopsies and imaging scans for response evaluation, with samples taken before and after PIPAC treatment. Researchers assess side effects, surgical complications, progression-free survival, and patient-reported symptoms using questionnaires and step count monitors. Participants are followed every 12 weeks for up to three years after treatment to monitor long-term effects and treatment outcomes.
CONDITIONS
Brief 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
- 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/mm³
- Platelet count of at least 100,000/mm³
- Hemoglobin level of at least 9 g/dl
- Serum total bilirubin no greater than 1.5 times the upper limit of normal
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) no greater than 2.5 times the upper limit of normal unless liver metastases or chronic liver disease present, then up to 5 times allowed
- Alkaline phosphatase no greater than twice the upper limit of normal
- Serum creatinine no greater than 1.5 times the upper limit of normal or creatinine clearance at least 40 ml/min
- No contraindications to laparoscopy
- Peritoneal disease must be visible on imaging or laparoscopy
- Patients must have progressed on at least one chemotherapy regimen (Arms 1 and 2); Arm 3 patients should have stable or responsive disease after at least 4 months of first-line chemotherapy
- For patients with hepatitis B, viral load must be undetectable on suppressive therapy if needed
- Hepatitis C patients must be treated and cured or have undetectable viral load if on treatment
- Women of childbearing potential and male partners must use effective contraception during the study and for 12 weeks after last treatment
- Laparoscopy must show PIPAC access is feasible, room for aerosol therapy, no impending bowel obstruction, 5 liters or less of ascites, and ineligibility for cytoreduction and HIPEC
You will not qualify if you...
- Presence of extra-peritoneal metastatic disease (gastric and colorectal/appendiceal)
- Prior maximum cumulative doses of anthracyclines for Arm 1 patients
- Known dihydropyrimidine dehydrogenase (DPD) deficiency in Arm 2 and Arm 3
- Bowel obstruction requiring nasogastric tube, feeding tube, or exclusive intravenous nutrition in Arms 2 and 3
- Severe allergic reactions to platinum-based chemotherapy in Arm 2
- Unrecovered significant toxicities from prior anti-cancer therapy except alopecia, hearing loss, or mild lab abnormalities in Arms 2 and 3
- Life expectancy less than 6 months in Arms 2 and 3
- Recent chemotherapy or surgery within specified weeks before enrollment
- Previous anaphylactic reaction to study chemotherapy drugs
- Receiving other investigational anti-cancer agents
- Ascites due to severe liver disease or portal vein thrombosis
- Planned simultaneous tumor debulking with gastrointestinal resection
- Uncontrolled illnesses such as severe heart, lung, kidney, or liver conditions
- Immunocompromised status or involvement in study planning
- Pregnancy
- Psychiatric or social conditions limiting study compliance
- Recent major infections requiring antibiotics
- Prior intra-abdominal aerosol chemotherapy in Arms 2 and 3
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 18 weeks
Participants receive pressurized intraperitoneal aerosol chemotherapy (PIPAC) with drugs specific to their assigned group. Treatment cycles occur every 4 to 6 weeks for up to 3 cycles, provided there is no disease progression or unacceptable toxicity.
Up to 3 treatment visits every 4 to 6 weeks
Duration - Up to 3 years
After completing treatment, participants are followed up every 12 weeks for up to 3 years to monitor safety, disease status, and quality of life.
Quarterly visits every 12 weeks
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here