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

Summary

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.

Conditions

• 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

Interventions

PROCEDURE

Biopsy

Undergo biopsy

DRUG

Cisplatin

Given via PIPAC

DRUG

Doxorubicin

Given via PIPAC

DRUG

Fluorouracil

Given IV

DEVICE

Intraperitoneal Chemotherapy

Undergo PIPAC

DRUG

Irinotecan

Given IV

DRUG

Leucovorin

Given IV

DRUG

Mitomycin

Given via PIPAC

DRUG

Oxaliplatin

Given via PIPAC

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• City of Hope Medical Center

  lead OTHER

Principal Investigators

• Thanh H Dellinger, MD · City of Hope Medical Center

• Mustafa Raoof, MD · City of Hope Medical Center

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-08-21

Primary Completion

2028-01-05

Completion

2028-01-05

FDA Drug

Yes

FDA Device

Yes

Countries

• United States

Study Locations