RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Safety and Efficacy of Pressurized Intraperitoneal Aerosolized Chemotherapy (PIPAC) in Ovarian, Uterine, Appendiceal, Colorectal, and Gastric Cancer Patients With Peritoneal Carcinomatosis (PC)

Quick Facts

Study Start:2020-08-21

Study Completion:2026-08-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04329494

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Principal Investigator

Thanh H Dellinger, MD

PRINCIPAL_INVESTIGATOR

City of Hope Medical Center

Mustafa Raoof, MD

PRINCIPAL_INVESTIGATOR

City of Hope Medical Center

Study Locations (Sites)

City of Hope Medical Center

Duarte, California, 91010

United States

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980

United States

Northwell Health Cancer Institute at Huntington

Greenlawn, New York, 11740

United States

Collaborators and Investigators

Sponsor: City of Hope Medical Center

Thanh H Dellinger, MD, PRINCIPAL_INVESTIGATOR, City of Hope Medical Center
Mustafa Raoof, MD, PRINCIPAL_INVESTIGATOR, City of Hope Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-08-21

Study Completion Date2026-08-05

Study Record Updates

Study Start Date2020-08-21

Study Completion Date2026-08-05

Terms related to this study

Additional Relevant MeSH Terms

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