This phase I trial tests the safety, side effects and best dose of nab-paclitaxel pressurized intraperitoneal aerosolized chemotherapy (PIPAC) in combination with second-line chemotherapy, paclitaxel and ramucirumab, and tests how well they work in treating stomach cancer that has spread from where it first started to the tissue that lines the abdominal wall and organs (peritoneal metastases). Paclitaxel is in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. Nab-paclitaxel is an albumin-stabilized nanoparticle formulation of paclitaxel which may have fewer side effects and work better than other forms of paclitaxel. PIPAC delivers chemotherapy, such as nab-paclitaxel, that has been turned into a fine mist (aerosolized) at a high pressure directly into the abdominal cavity. Aerosolized chemotherapy delivered directly into the peritoneal space has been shown to deliver higher drug concentrations to the tumor. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Giving nab-paclitaxel PIPAC in combination with paclitaxel and ramucirumab may be safe, tolerable, and/or effective in treating gastric cancer patients with peritoneal metastases.
Patients must have failed first-line systemic therapy (fluorouracil, leucovorin calcium, oxaliplatin [FOLFOX] with or without immunotherapy, or other fluoropyrimidine and platinum-based therapy)
Prior immunotherapy allowed
Up to 4 cycles of second-line therapy allowed if no progression is documented
Documented informed consent of the participant and/or legally authorized representative
Intolerance to taxanes
Bowel obstruction requiring exclusive total parenteral nutrition
Any history of, or current, brain or subdural metastases
Life expectancy < 3 months
City of Hope Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator