Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) With Oxaliplatin In Patients With Peritoneal Carcinomatosis

Sponsor
National University Hospital, Singapore
Study ID
NCT03172416
Phase
PHASE1
Status
Unknown

Conditions

  • Peritoneal Carcinomatosis

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Oxaliplatin — DRUG
    This study started as a prospective, single arm phase I trial in a 3 + 3 dose escalation evaluating the safety and tolerability of PIPAC using oxaliplatin in patients with peritoneal carcinomatosis.
  • Oxaliplatin & Nivolumab — DRUG
    PIPAC oxaliplatin 90mg/m2 has been well tolerated in our Cohort 1 study. Hence, we added a second cohort (Cohort 2) which combines PIPAC oxaliplatin at 90mg/m2 every 6 weeks with IV nivolumab at 240mg every 2 weeks to evaluate the safety and tolerability of combination therapy.

Study Details

PIPAC is a procedure that involves the administration of intraperitoneal chemotherapy using an innovative concept that enhances the efficacy by taking advantage of the physical properties of gas and pressure. The chemotherapy drugs will be delivered in aerosolised form. This results in a superior distribution and depth of penetration of the drug. This research study serves to determine the safety profile and tolerability of PIPAC with oxaliplatin. It may offer a novel and effective option of treatment for patients with peritoneal carcinomatosis, who, at present have limited options involving the use of systemic chemotherapy and who suffer from poor life expectancy and poor quality of life. To date, most trials have used PIPAC cisplatin with doxorubicin, or oxaliplatin alone, and more studies are on-going globally. Intravenous (IV) nivolumab has been approved for the treatment of progressive gastric cancer after conventional chemotherapy. PIPAC in combination with nivolumab may have the potential to improve immune activation and response to immune checkpoint inhibition for patients with peritoneal disease. Hence we propose an amendment to our trial protocol for the addition of a second cohort (Cohort 2) to investigate the safety and tolerability of the combination of PIPAC oxaliplatin and IV nivolumab.

Key Dates

Start date
Apr 12, 2017
Status verified
May 2024
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024

Study Design

Enrollment
21 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Oxaliplatin
    3+3 dose escalation of oxaliplatin This is a single arm phase I trial in a 3 + 3 dose escalation and cohort expansion design evaluating the safety and tolerability of PIPAC using oxaliplatin. The pre-planned dose levels of oxaliplatin are 45mg/m2 (Cohort 1), 60mg/m2 (Cohort 2), 90mg/m2 (Cohort 3),120mg/m2 (Cohort 4) and 150mg/m2 (Cohort 5) administered as PIPAC. Successive cohorts of patients (3 participants/cohort) will be enrolled and started on a fixed dose of oxaliplatin. The protocol specifies oxaliplatin 45mg/m2 once every 6 weeks for Cohort 1. Dose escalation continues until dose-limiting toxicities (DLT) are observed in one-third of participants. If no DLT occurs, the next cohort will be enrolled at the next planned dose level. If 1 DLT occurs in a cohort, another 3 patients will be treated with the same dose level. Oxaliplatin every 6 weeks with IV nivolumab every 2 weeks PIPAC oxaliplatin at 90mg/m2 every 6 weeks with IV nivolumab at 240mg every 2 weeks

Primary Outcome Measure

Safety Profile of PIPAC with oxaliplatin by monitoring adverse event profile of patient undergo PIPAC [ Time Frame: 1 to 2 years ]

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