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..
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
55
Given IP-IV, every 2 weeks
Given IP-IV, every 3 weeks
Chao Family Comprehensive Cancer Center, University of California, Irvine
Orange, California, United States
RECRUITINGProtocol Treatment Completion Rate
Number of patients that complete treatment at 2 cycles
Time frame: 6 weeks
Overall Survival of Participants
To assess the overall survival of participants from the start of systemic treatment to the death from any cause.
Time frame: 3 years
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.
Time frame: 3 years
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.
Time frame: 1 year
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.
Time frame: 1 year
Overall Response Rate (ORR) by RECIST v1.1
Sum of Complete Response (CR) and Partial Response (PR) by RECIST v1.1. Per Response Evaluation Criteria in Solid Tumors (RECIST v1.1): Complete Response (CR) is defined as the disappearance of all target lesions; Partial Response (PR) is defined as a 30% decrease in the sum of diameters of target lesions. ORR = CR + PR
Time frame: 1 year
Chao Family Comprehensive Cancer Center University of California, Irvine
CONTACT
University of California Irvine Medical
CONTACT
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