This is a phase II open-label, basket clinical trial to assess the feasibility of systemic and Intraperitoneal chemotherapy in subjects with Gastrointestinal Malignancies with Peritoneal Carcinomatosis. These are subjects who have a proven primary carcinoma of the digestive tract..
Cohort A: Patients must have histologically or cytologically confirmed primary gastric or gastroesophageal adenocarcinoma with a clinical diagnosis of metachronous PC with a history of prior gastric cancer resection. Extraperitoneal metastases are allowed.
Cohort B: Patients must have histologically or cytologically confirmed primary colorectal or appendiceal adenocarcinoma with PC . Extraperitoneal metastases are allowed. Patients with PC amenable to cytoreductive surgery (CRS) without the need for upfront systemic therapy as determined by a peritoneal malignancy surgeon within 4 weeks prior to enrollment are excluded.
Cohort C: Patients must have adenocarcinomas of the digestive tract with PC not included in Cohorts A and B (including but not limited to carcinomas of the small bowel and hepatobiliary tract).
Must have peritoneal cytology positive disease or peritoneal carcinomatosis detected by imaging, laparoscopy or laparotomy
Any evidence of small or large bowel obstruction with the exception of gastric outlet obstruction due to primary malignancy
Uncontrolled intercurrent illness including, but not limited to, the following conditions: Ongoing or active infection; Symptomatic congestive heart failure; Stroke (including transient ischemic attack [TIA]), myocardial infarction (MI), or other ischemic event,) within 3 months before initiation of treatment; Unstable angina pectoris; Cardiac arrhythmia
History of another primary cancer within the last 3 years with the exception of non-melanoma skin cancer, early-stage prostate cancer, or curatively treated cervical carcinoma in-situ and not treated with systemic therapy.
History of prior iterative intraperitonealtherapy administered either as HIPEC, PIPAC or NIPEC. Single exposure to HIPEC at the time of cytreduction is not an exclusion
Parallel
Paclitaxel Q2W
DrugGiven IP-IV, every 2 weeks
Paclitaxcel Q3W
DrugGiven IP-IV, every 3 weeks
6
Treatment groupsSee each treatment group below.
Protocol Treatment Completion Rate
Number of patients that complete treatment at 2 cycles
Overall Survival of Participants
To assess the overall survival of participants from the start of systemic treatment to the death from any cause.
Participants with Progression Free Survival
Progression-free survival is defined as the duration of time from start of systemic treatment to time of progression, death, or clinical deterioration attributed to disease progression as judged by the investigator. Radiographic progression is defined using the Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) as a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm and/or appearance of new lesions.
Patient Reported Quality of Life Outcomes
To assess the quality of life of participants such as mobility, self-care, daily activities, pain/discomfort and anxiety/depression and a visual analog scale (VAS). VAS consists of endpoints labeled best imaginable health status at the top and worse imaginable health state at the bottom having numeric values of 100 and 0 respectively.
Incidence of Treatment-Emergent Adverse Events [Safety]
To evaluate the safety of IP paclitaxel and IV paclitaxel, 5-FU, and leucovorin in patients with primary gastric/GEJ adenocarinoma with peritoneal carcinomatosis determined by the incidence of treatment-emergent adverse events. Adverse events are based on the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 5.0.
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