A Safety to Evaluate the Safety and Effectiveness of Pressurized Intraperitoneal Aerosolized Chemotherapy in Ovarian, Uterine, Colorectal, and Gastric Cancer Patients

Overview

About this study

The purpose of this study is to evaluate the safety of pressurized intraperitoneal aerosol chemotherapy (PIPAC) in 2 groups of patients with peritoneal carcinomatosis (PC), either due to primary ovarian, uterine, or gastric carcinoma (Arm 1) or to primary colorectal carcinoma (Arm 2), based on treatment-related adverse events reported by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.  

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Documented informed consent of the participant and/or legally authorized representative.
  • Patients must have histologically confirmed ovarian, uterine, gastric, or colorectal cancer with peritoneal metastases.
  • Prior intraperitoneal 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 ≥ 9g/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 are present or unless patients is known 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 dose 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.
  • 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 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 (vagin2a 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;
    • Not a candidate for cytoreduction and hyperthermic intraperitoneal chemotherapy (HIPEC). 

Exclusion Criteria:  

  • Gastric and colorectal:  
    • 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):  
    • Known dihydropyrimidine dehydrogenase deficiency (DPD) deficiency.
  • Bowel obstruction requiring nasogastric tube, percutaneous endoscopic gastrostomy or exclusive total parenteral nutrition.
  • Prior unanticipated severe reaction or hypersensitivity to platinum based compounds.
  • 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.
  • Life expectancy of less than 6 months.
  • 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.
  • Previous anaphylactic reaction to the chemotherapy drug used.
  • Patients may not be receiving any other investigational or concurrent anti-cancer agents.
  • Ascites due to decompensated liver cirrhosis; portal vein thrombosis.
  • Simultaneous tumor debulking with gastrointestinal resection.
  • 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 impairmen.
  • Immunocompromised patients such as those with an immunosuppressive medication or a known disease of the immune system.
  • Involvement in the planning and conduct of the study.
  • Pregnancy.
  • Untreated central nervous system (CNS) metastases; patients whose CNS metastases have  been treated by surgery or radiotherapy, who are no longer on corticosteroids, and who are neurologically stable may be enrolled. 
  • Patients with psychiatric illness/social situations that would limit compliance with study requirements.
  • 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.
  • Major systemic infection requiring antibiotics 72 hours or less prior to the first  dose of study drug.
  • Exclusive total parenteral nutrition.
  • Prior intra-abdominal aerosol chemotherapy.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Amit Merchea, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
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CLS-20517716

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