PIPAC for the Treatment of Peritoneal Carcinomatosis in Patients With Ovarian, Uterine, Appendiceal, Colorectal, or Gastric Cancer
Safety and Efficacy of Pressurized Intraperitoneal Aerosolized Chemotherapy (PIPAC) in Ovarian, Uterine, Appendiceal, Colorectal, and Gastric Cancer Patients With Peritoneal Carcinomatosis (PC)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Mentioned in the study description
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 3 years
- Procedures mentioned: CT scans, Biopsies, Questionnaires
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Response Evaluation Criteria in Solid Tumors (RECIST), if available, version 1.1 via computed tomography (CT) scan at baseline (week 10, and 6 weeks after completing treatment; and at 18 weeks)."
- "Peritoneal regression grading score (PRGS) via biopsy at each cycle (both pre-PIPAC and post-PIPAC peritoneal samples will be obtained)."
- "Patient-reported health state/quality of life and symptoms before treatment and at 6, 12, and 18 weeks as measured by the European Quality of Life Five Dimension Five Level Scale Questionnaire (EQ-5D-5L) and MD Anderson Symptom Inventory (MDASI)."
- "After completion of study treatment, patients are followed up every 12 weeks for up to 3 years."
- Compensation
- Mentioned in the study description
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This early-stage study tests the side effects of PIPAC, a way to spray chemotherapy as a fine mist inside the belly during surgery through small cuts. It is for people with ovarian, uterine, appendix, colon, rectal, or stomach cancer that has spread to the lining inside the belly.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You or your legal representative must give written consent to join.
- A tissue test must confirm one of the listed cancers. Cancer in the belly lining must be seen on scans or during surgery.
- You must be able to care for yourself and be up and about at least half of your waking hours.
- Blood tests must meet the study’s limits for blood cell counts and liver and kidney function.
- In groups 1 and 2, cancer must have worsened after at least one chemotherapy treatment plan. In group 3, cancer must be stable or shrinking after at least 4 months of first treatment with chemotherapy that travels through the body.
- If you have hepatitis B, the virus must be too low to detect, with treatment if needed. Hepatitis C must be cured or too low to detect during treatment.
- If you or your partner could become pregnant, you must use birth control during the study and for up to 12 weeks after the last study drug dose.
- You must be able to have surgery through small cuts. Surgery must show safe access and room for the mist, no bowel blockage about to happen, and no more than 5 liters of belly fluid. You must not be a candidate for tumor-removal surgery with heated chemotherapy.
Who can't join
- For stomach, colon, rectal, or appendix cancer: cancer has spread outside the belly lining.
- Group 1: you have already received the lifetime dose limit of certain chemotherapy drugs, such as doxorubicin.
- Groups 2 and 3: you lack DPD, a protein needed to break down some chemotherapy; have a bowel blockage needing a tube or feeding only through a vein; or are expected to live less than 6 months.
- Groups 2 and 3: you have certain lasting side effects from earlier cancer treatment or a past life-threatening allergy to the study chemotherapy. Group 2 also excludes severe reactions to platinum chemotherapy.
- Groups 2 and 3: chemotherapy or surgery was too recent—within 4 weeks for group 2 or 2 weeks for group 3. Both require 6 weeks after bevacizumab and a waiting period for other cancer drugs.
- Groups 2 and 3: you are taking another experimental cancer drug, have belly fluid from severe liver scarring or a clot in the liver’s main vein, or need tumor removal with bowel surgery at the same time.
- Group 2: pregnancy, a weak immune system, serious uncontrolled illness, certain recent hospital stays, recent major infection, feeding only through a vein, or past chemotherapy mist inside the belly. Other exclusions include another cancer treatment, helping run the study, or mental health or social issues that prevent following study rules.
- Group 3: cancer worsened on both the first and second treatment plans; chemotherapy caused blood problems needing major dose cuts; prior fluorouracil or irinotecan caused major dose cuts or delays over 1 week; or you have an uncontrolled illness, including an active infection.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * 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 * Not a candidate for cytoreduction and HIPEC Exclusion Criteria: * 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 * Arm 3 (colorectal/appendiceal): Known DPD deficiency * Arm 3 (colorectal/appendiceal): Bowel obstruction requiring nasogastric tube, percutaneous endoscopic gastrostomy or exclusive total parenteral nutrition * Arm 3 (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 3 (colorectal/appendiceal): Life expectancy of less than 6 months * Arm 3 (colorectal/appendiceal): Chemotherapy or surgery within the last 2 weeks prior to enrollment (6 weeks for prior bevacizumab therapy). Five half-lives for other anti-cancer agents * Arm 3 (colorectal/appendiceal): Previous anaphylactic reaction to the chemotherapy drug used * Arm 3 (colorectal/appendiceal): Patients may not be receiving any other investigational anti-cancer agents * Arm 3 (colorectal/appendiceal): Ascites due to decompensated liver cirrhosis; portal vein thrombosis * Arm 3 (colorectal/appendiceal): Simultaneous tumor debulking with gastrointestinal resection * Arm 3 (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 3 (colorectal/appendiceal): Immunocompromised patients such as those with an immunosuppressive medication or a known disease of the immune system * Arm 3 (colorectal/appendiceal): Involvement in the planning and conduct of the study * Arm 3 (colorectal/appendiceal): Pregnancy * Arm 3 (colorectal/appendiceal): Patients with psychiatric illness/social situations that would limit compliance with study requirements * Arm 3 (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 3 (colorectal/appendiceal): Major systemic infection requiring antibiotics 72 hours or less prior to the first dose of study drug * Arm 3 (colorectal/appendiceal): Exclusive total parenteral nutrition * Arm 3 (colorectal/appendiceal): Prior intra-abdominal aerosol chemotherapy
Study sites (3)
CA
- City of Hope Medical Center · Duarte, CA 91010Thanh H. Dellinger · Study contact · 626-218-1379 · tdellinger@coh.orgThanh H. Dellinger · Principal investigatorMore trials in Duarte
FL
- Mayo Clinic in Florida · Jacksonville, FL 32224-9980More trials in Jacksonville
NY
- Northwell Health Cancer Institute at Huntington · Greenlawn, NY 11740Richard L. Whelan · Study contact · 212-434-4860 · rwhelan1@northwell.eduRichard L. Whelan · Principal investigatorMore trials in Greenlawn