What is PIPAC studying for peritoneal carcinomatosis in cancer patients?

PIPAC is being studied to assess its safety and effects in patients with ovarian, uterine, appendiceal, colorectal, or gastric cancers that have spread to the abdominal lining. The study evaluates different chemotherapy drugs delivered as a fine mist into the abdomen to better understand side effects, dosage, and tumor response. This research is sponsored by City of Hope Medical Center and aims to improve treatment options for this condition.

Who may be eligible for this peritoneal carcinomatosis clinical trial?

Adults aged 18 years or older with ovarian, uterine, gastric, appendiceal, or colorectal cancer that has spread to the peritoneum may be eligible. Participants should have an ECOG performance status of 2 or less and be able to undergo laparoscopic procedures. Prior chemotherapy treatment is allowed, and both men and women can participate. Please review eligibility criteria for more details.

Is there any cost to participate in this peritoneal carcinomatosis clinical trial?

Study-related care, including the chemotherapy drugs and all trial visits, is provided at no cost. However, personal expenses such as travel or lodging are not guaranteed to be covered and may vary. Participants should plan accordingly for any additional costs while taking part in the trial.

Actively Recruiting

Phase 1

Age: 18Years +

All Genders

ID04329494

Safety and Side Effects of Pressurized Intraperitoneal Aerosol Chemotherapy PIPAC for Treating Peritoneal Carcinomatosis in Patients With Ovarian, Uterine, Appendiceal, Colorectal, or Gastric Cancer

Led by City of Hope Medical Center · Updated on 2026-07-22

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effects of pressurized intraperitoneal aerosol chemotherapy PIPAC in patients with ovarian, uterine, appendiceal, colorectal, or stomach gastric cancer that has spread to the lining of the abdominal cavity, known as peritoneal carcinomatosis. This phase I trial aims to understand how PIPAC works in different groups of patients based on their primary cancer type, including identifying the maximum tolerated dose of one chemotherapy drug in a specific subgroup. The study also explores the ability to proceed to surgery, tumor response, progression-free survival, technical success of the procedure, patient quality of life, and functional status. Participants are assigned to one of three groups based on their cancer type and prior treatments. Treatments include PIPAC delivered chemotherapy drugs such as doxorubicin, cisplatin, oxaliplatin, mitomycin, along with intravenous drugs like leucovorin, fluorouracil, and irinotecan. Each group receives up to three treatment cycles every 4 to 6 weeks if there is no disease progression or unacceptable side effects. After treatment, patients are followed every 12 weeks for up to three years. During the study, participants undergo laparoscopic procedures to deliver chemotherapy and collect biopsies for tumor assessment. Imaging with CT scans and biopsy samples are used to evaluate tumor response. Researchers monitor side effects, surgical complications, and patient-reported symptoms and quality of life through questionnaires. Functional status is tracked using a wristband pedometer. The study measures dose-limiting toxicities and adverse events up to 18 weeks, with additional long-term follow-up extending to three years to assess progression-free survival and technical success of PIPAC.

CONDITIONS

Brief Title

PIPAC for the Treatment of Peritoneal Carcinomatosis in Patients With Ovarian, Uterine, Appendiceal, Colorectal, or Gastric Cancer

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Signed informed consent obtained from participant or legal representative
Histologically confirmed ovarian, uterine, gastric, appendiceal, or colorectal cancer with peritoneal carcinomatosis
Prior intraperitoneal chemotherapy allowed
Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
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 less than or equal to 1.5 times the upper limit of normal (ULN)
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to 2.5 times ULN, or up to 5 times ULN if liver metastases or chronic hepatitis present
Alkaline phosphatase less than or equal to 2 times ULN
Serum creatinine less than or equal to 1.5 times ULN or creatinine clearance at least 40 ml/min
No contraindications for laparoscopy
Visible peritoneal disease on imaging or laparoscopy
Progressed on at least one prior chemotherapy regimen (Arms 1 and 2)
Stable or responsive disease after at least 4 months of first-line chemotherapy (Arm 3)
Undetectable hepatitis B viral load if on suppressive therapy
Hepatitis C infection treated and cured or with undetectable viral load if currently treated
Women of childbearing potential and males with partners of childbearing potential must use effective contraception during the study and for 12 weeks after
Laparoscopy findings allowing PIPAC: feasible access, room for aerosol therapy, no bowel obstruction, ascites less than or equal to 5 liters, not a candidate for cytoreductive surgery and HIPEC

You will not qualify if you...

Presence of extra-peritoneal metastatic disease (gastric, colorectal, appendiceal cancers)
For Arm 1: Previous maximum cumulative doses of anthracyclines (doxorubicin, daunorubicin, epirubicin, idarubicin) or anthracenediones
For Arm 2: Known dihydropyrimidine dehydrogenase (DPD) deficiency
For Arm 2: Bowel obstruction requiring nasogastric tube, feeding tube, or total parenteral nutrition
For Arm 2: Severe allergic reaction to platinum compounds
For Arm 2: Unrecovered side effects from prior cancer treatments (except alopecia, hearing loss, or minor lab abnormalities); grade 2 peripheral neuropathy allowed
For Arm 2: Life expectancy less than 6 months
For Arm 2: Chemotherapy or surgery within 4 weeks before enrollment (6 weeks for bevacizumab)
For Arm 2: Previous anaphylactic reaction to study chemotherapy drugs
For Arm 2: Concurrent or other investigational anticancer treatments
For Arm 2: Ascites due to severe liver disease or portal vein thrombosis
For Arm 2: Simultaneous tumor debulking surgery
For Arm 2: Uncontrolled illness including active infection, heart failure, recent heart attack, severe arrhythmias, kidney or liver failure, or low blood counts
For Arm 2: Immunosuppressed patients
For Arm 2: Involvement in planning or conduct of the study
For Arm 2: Pregnancy
For Arm 2: Psychiatric or social issues limiting study compliance
For Arm 2: Severe heart or lung disease requiring recent hospitalization
For Arm 2: Major infection requiring antibiotics within 72 hours before study drug
For Arm 2: Exclusive total parenteral nutrition
For Arm 2: Prior intra-abdominal aerosol chemotherapy
For Arm 3: Progression on first and second line systemic therapy
For Arm 3: Significant blood toxicity requiring dose reduction during chemotherapy
For Arm 3: Intolerance to prior fluorouracil or irinotecan requiring dose reduction or treatment interruption
For Arm 3: Known DPD deficiency
For Arm 3: Bowel obstruction requiring tubes or exclusive total parenteral nutrition
For Arm 3: Unrecovered side effects from prior treatment (except alopecia, hearing loss, or minor lab abnormalities); grade 2 peripheral neuropathy allowed
For Arm 3: Life expectancy less than 6 months
For Arm 3: Chemotherapy or surgery within 2 weeks before enrollment (6 weeks for bevacizumab)
For Arm 3: Previous anaphylactic drug reaction
For Arm 3: Concurrent investigational anticancer treatments
For Arm 3: Ascites due to severe liver disease or portal vein thrombosis
For Arm 3: Simultaneous tumor debulking surgery
For Arm 3: Uncontrolled illness including infection, heart failure, recent heart attack, severe arrhythmias, kidney or liver failure, or low blood counts
For Arm 3: Immunosuppressed patients
For Arm 3: Involvement in planning or conduct of the study
For Arm 3: Pregnancy
For Arm 3: Psychiatric or social issues limiting study compliance
For Arm 3: Severe heart or lung disease requiring recent hospitalization
For Arm 3: Major infection requiring antibiotics within 72 hours before study drug
For Arm 3: Exclusive total parenteral nutrition
For Arm 3: Prior intra-abdominal aerosol chemotherapy

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Safety and Side Effects of Pressurized Intraperitoneal Aerosol Chemotherapy PIPAC for Treating Peritoneal Carcinomatosis in Patients With Ovarian, Uterine, Appendiceal, Colorectal, or Gastric Cancer

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria