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
Single group
Biopsy
Procedure/SurgeryUndergo tumor biopsy
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
Computed Tomography
Procedure/SurgeryUndergo CT
Magnetic Resonance Imaging
Procedure/SurgeryUndergo MRI
Medical Device Usage and Evaluation
Other interventionGiven PIPAC
Nab-paclitaxel
DrugGiven IP
Paclitaxel
DrugGiven IV
Questionnaire Administration
Other interventionAncillary studies
Ramucirumab
Biological/VaccineGiven IV
Dose-limiting toxicity (DLT)
Will be evaluated and graded based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. Toxicities will be summarized by type (organ affected or laboratory determination), severity, time of onset, duration, probable association with the study treatment, and reversibility or outcome. Rates and associated 95% Clopper and Pearson binomial confidence limits will be estimated.
Incidence of treatment-related adverse events (AEs)
Will be evaluated and graded based on NCI CTCAE v 5.0. The number and percent of patients with AEs will be tabulated by system organ class and preferred term using the Medical Dictionary for Regulatory Activities preferred term dictionary. The tabulations will be generated so that the number and percent of patients with events in each severity, relatedness, and serious category can be obtained for each preferred term. Listings and narratives will be provided for deaths on study, serious AEs, DLTs, and events leading to discontinuation of treatment.
Incidence of post-operative surgical complications
Will be evaluated using Clavien-Dindo classification. Results will be strictly descriptive in nature.
Objective response rate (ORR)
Will be evaluated according to Response Evaluation Criteria in Solid Tumors v 1.1. ORR will be defined as the percentage of evaluable patients who have achieved complete response (CR), partial response (PR), or stable disease (SD). Rates and associated 95% Clopper and Pearson binomial confidence limits will be estimated.
Peritoneal Carcinomatosis Index (PCI)
PCI will be defined as the percentage of evaluable patients who have achieved CR, PR, or SD. Confidence intervals for the true success proportion will be calculated according to the approach of Clopper and Pearson
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City of Hope Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
