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

Recruiting now · Phase 1

Conditions studied: Clinical Stage IV Gastric Cancer AJCC v8, Clinical Stage IVA Gastric Cancer AJCC v8, Clinical Stage IVB Gastric Cancer AJCC v8, Malignant Uterine Neoplasm, Metastatic Appendix Carcinoma, Metastatic Colorectal Carcinoma, Metastatic Gastric Carcinoma, Metastatic Malignant Neoplasm in the Peritoneum, Metastatic Malignant Solid Neoplasm, Metastatic Ovarian Carcinoma, Pathologic Stage IV Gastric Cancer AJCC v8, Peritoneal Carcinomatosis, Postneoadjuvant Therapy Stage IV Gastric Cancer AJCC v8, Stage IV Appendix Carcinoma AJCC v8, Stage IV Colorectal Cancer AJCC v8, Stage IV Ovarian Cancer AJCC v8, Stage IV Uterine Corpus Cancer AJCC v8, Stage IVA Appendix Carcinoma AJCC v8, Stage IVA Colorectal Cancer AJCC v8, Stage IVA Ovarian Cancer AJCC v8, Stage IVA Uterine Corpus Cancer AJCC v8, Stage IVB Appendix Carcinoma AJCC v8, Stage IVB Colorectal Cancer AJCC v8, Stage IVB Ovarian Cancer AJCC v8, Stage IVB Uterine Corpus Cancer AJCC v8, Stage IVC Appendix Carcinoma AJCC v8, Stage IVC Colorectal Cancer AJCC v8

In brief

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.

Key facts

Study ID: NCT04329494
Run by: City of Hope Medical Center
People needed: 49
Starts: 2020-08-21
Expected to finish: 2028-01-05
Last updated by the study team: 2026-07-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Documented informed consent of the participant and/or legally authorized representative
Patients must have histologically confirmed ovarian, uterine, gastric, appendiceal or colorectal cancer with PC
Prior IP chemotherapy is permitted
Eastern Cooperative Oncology Group (ECOG) performance status (PS) =< 2
Absolute neutrophil count (ANC) >= 1500/mm\^3
Platelets >= 100,000/mm\^3
Hemoglobin >= 9 g/dl
Serum total bilirubin =< 1.5 x upper limit of normal (ULN)
Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) and aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) =< 2.5 x ULN, unless liver metastases (Arm 1) are present or unless patients is know to have chronic liver disease (hepatitis) in which case AST and ALT must be =< 5 x ULN
Alkaline phosphatase =< 2 x ULN
Serum creatinine (sCr) =< 1.5 x ULN, or creatinine clearance (Ccr) >= 40 ml/min as calculated by the Cockcroft-Gault formula
No contraindications for a laparoscopy
The peritoneal disease does not have to be measurable by RECIST 1.1 but needs to be visible on cross sectional imaging or diagnostic laparoscopy
Patients must have progressed on at least one evidence-based chemotherapeutic regimen (Arm 1 and 2). For Arm 3, patients should have stable or responsive disease on at least 4 months first-line systemic chemotherapy
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 12 weeks after the last dose of investigational product 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 define 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 to be 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

You may not qualify if…

Gastric and colorectal/appendiceal:
Extra-peritoneal metastatic disease
Arm 1 (ovarian, uterine, gastric): Previous treatment with maximum cumulative doses of doxorubicin, daunorubicin, epirubicin, idarubicin, and/or other anthracyclines and anthracenediones
Arm 2 (colorectal/appendiceal): Known dihydropyrimidine dehydrogenase deficiency (DPD) deficiency
Arm 2 (colorectal/appendiceal): Bowel obstruction requiring nasogastric tube, percutaneous endoscopic gastrostomy or exclusive total parenteral nutrition
Arm 2 (colorectal/appendiceal): Prior unanticipated severe reaction or hypersensitivity to platinum based compounds
Arm 2 (colorectal/appendiceal): Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > grade 1), with the exception of alopecia, hearing loss, or non-clinically significant laboratory abnormalities. Grade 2 peripheral neuropathy is permitted
Arm 2 (colorectal/appendiceal): Life expectancy of less than 6 months
Arm 2 (colorectal/appendiceal): Chemotherapy or surgery within the last 4 weeks prior to enrollment (6 weeks for prior bevacizumab therapy). Five half-lives for other anti-cancer agents
Arm 2 (colorectal/appendiceal): Previous anaphylactic reaction to the chemotherapy drug used
Arm 2 (colorectal/appendiceal): Patients may not be receiving any other investigational or concurrent anti-cancer agents
Arm 2 (colorectal/appendiceal): Ascites due to decompensated liver cirrhosis; portal vein thrombosis
Arm 2 (colorectal/appendiceal): Simultaneous tumor debulking with gastrointestinal resection
Arm 2 (colorectal/appendiceal): 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
Arm 2 (colorectal/appendiceal): Immunocompromised patients such as those with an immunosuppressive medication or a known disease of the immune system
Arm 2 (colorectal/appendiceal): Involvement in the planning and conduct of the study
Arm 2 (colorectal/appendiceal): Pregnancy
Arm 2 (colorectal/appendiceal): Patients with psychiatric illness/social situations that would limit compliance with study requirements
Arm 2 (colorectal/appendiceal): 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
Arm 2 (colorectal/appendiceal): Major systemic infection requiring antibiotics 72 hours or less prior to the first dose of study drug
Arm 2 (colorectal/appendiceal): Exclusive total parenteral nutrition
Arm 2 (colorectal/appendiceal): Prior intra-abdominal aerosol chemotherapy
Arm 3 (colorectal/appendiceal): Progression on first- AND second-line systemic therapy
Arm 3 (colorectal/appendiceal): Hematologic toxicities requiring significant dose reductions while on systemic chemotherapy
Arm 3 (colorectal/appendiceal): Intolerance to prior 5-FU at 2400mg/m\^2 IV every 2 weeks or to irinotecan at 180mg/m\^2. Intolerance is defined as the need of significant dose reduction or treatment interruption of > 1 week due to toxicity

Where it is running

City of Hope Medical Center — Duarte, California, United States (enrolling)
Northwell Health Cancer Institute at Huntington — Greenlawn, New York, United States (enrolling)
Mayo Clinic in Florida — Jacksonville, Florida, United States

Full record on ClinicalTrials.gov

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