At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed ovarian, uterine, gastric, appendiceal or colorectal cancer with peritoneal carcinomatosis
- ✓Peritoneal disease visible on cross-sectional imaging or diagnostic laparoscopy
- ✓Prior intraperitoneal chemotherapy is permitted
- ✓Documented informed consent
- ✕Gastric and colorectal/appendiceal: extra-peritoneal metastatic disease
- ✕Arm 1: Prior treatment with maximum cumulative doses of anthracyclines and anthracenediones
- ✕Arm 2/3: Known dihydropyrimidine dehydrogenase (DPD) deficiency
- ✕Arm 2/3: Bowel obstruction requiring nasogastric tube, percutaneous endoscopic gastrostomy, or exclusive total parenteral nutrition
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety and Efficacy of Pressurized Intraperitoneal Aerosolized Chemotherapy (PIPAC) in Ovarian, Uterine, Appendiceal, Colorectal, and Gastric Cancer Patients With Peritoneal Carcinomatosis (PC)
In Brief
A Phase 1 clinical trial evaluating Biopsy, Cisplatin, and 9 other interventions for Clinical Stage IV Gastric Cancer AJCC v8 and 26 related conditions. Currently recruiting, targeting 49 participants across 3 sites.
Detailed 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.
Study Details
Timeline
Interventions
Undergo biopsy
Given via PIPAC
Given via PIPAC
Given IV
Undergo PIPAC
Given IV
Given IV
Given via PIPAC
Given via PIPAC
Ancillary studies
Ancillary studies