Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) With Oxaliplatin In Patients With Peritoneal Carcinomatosis (PIPAC)
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|ClinicalTrials.gov Identifier: NCT03172416|
Recruitment Status : Unknown
Verified January 2017 by National University Hospital, Singapore.
Recruitment status was: Recruiting
First Posted : June 1, 2017
Last Update Posted : June 1, 2017
|Condition or disease||Intervention/treatment||Phase|
|Peritoneal Carcinomatosis||Drug: Oxaliplatin||Phase 1|
The median survival of patients with unresectable gastric cancer treated with systemic chemotherapy is about 12 months. In patients with histologically proven unresectable or recurrent gastric cancer limited to the peritoneum and/or cancer cells in peritoneal cytology, the combination of i.p. paclitaxel with systemic chemotherapy reported a median survival time of 23.6 months. However, a phase III trial (PHOENIX-GC trial) comparing IP regimen with systemic chemotherapy versus systemic therapy alone in Japan recently reported preliminary data which did not show any superiority of the IP regimen.PIPAC is an innovative intraperitoneal chemotherapy concept that enhances the efficacy by taking advantage of the physical properties of gas and pressure. This results in a superior distribution and depth of penetration of the drug. To date, most phase II trials utilising PIPAC involve the use of cisplatin and doxorubicin4-6. Only two prior trials have utilised oxaliplatin in PIPAC for peritoneal carcinomatosis. Oxaliplatin is an approved drug for systemic chemotherapy, with well documented use intraperitoneally via hyperthermic intraperitoneal chemotherapy (HIPEC) as well. This makes is a favourable agent for PIPAC in early phase studies. The dose of oxaliplatin utilised for PIPAC in the literature has thus far been arbitrarily set at 92 mg/m2, which is approximately 80% of the drug concentration used in HIPEC. Furthermore, these studies were performed on patients with a recent or concurrent administration of systemic chemotherapy, which may make interpretation of the side effects and safety profile difficult to interpret. In this study, we intend to determine the safety profile and tolerability of PIPAC with oxaliplatin by assessment of dose limiting toxicities and the adverse event profile.
The aim is to determine the safety profile and tolerability of PIPAC with oxaliplatin by assessment of dose limiting toxicities and the adverse event profile. The secondary objective is to evaluate the clinical and pathological response of PIPAC with oxaliplatin as well as to identify the pharmacokinetic profile of oxaliplatin administered via PIPAC.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1 Study of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) With Oxaliplatin In Patients With Peritoneal Carcinomatosis|
|Actual Study Start Date :||April 12, 2017|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||January 2019|
|3+3 dose escalation of PIPAC using oxaloplatin||
This is a prospective, single arm phase I trial in a 3 + 3 dose escalation and cohort expansion design evaluating the safety and tolerability of PIPAC using oxaliplatin in patients with peritoneal carcinomatosis.
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.
- Safety Profile of PIPAC with oxaliplatin by monitoring adverse event profile of patient undergo PIPAC [ Time Frame: 1 to 2 years ]
- Tolerability of PIPAC with oxaliplatin by monitoring dose limiting toxicities. [ Time Frame: 1-2 years ]
- Clinical response of PIPAC with oxaliplatin according to Peritoneal Cancer Index (PCI) [ Time Frame: 1-2 years ]
- Pathological response of PIPAC with oxaliplatin according to Peritoneal Regression Grade Scoring (PRGS) System [ Time Frame: 1-2 years ]
- Maximum concentration (Cmax) of oxaliplatin administered via PIPAC using blood drawn from patient. [ Time Frame: Pre-dose; 30 and 45 minutes; and 1, 2, 4, 8, 24, and 30 hours. ]Maximum concentration (Cmax) of oxaliplatin, for patients with peritoneal carcinomatosis after PIPAC administration.
- Half-life (t1/2) of oxaliplatin administered via PIPAC using blood drawn from patient. [ Time Frame: Pre-dose; 30 and 45 minutes; and 1, 2, 4, 8, 24, and 30 hours. ]Half-life (t1/2) of oxaliplatin for patients with peritoneal carcinomatosis after PIPAC administration.
- Area under the curve (AUC) of oxaliplatin administered via PIPAC using blood drawn from patient. [ Time Frame: Pre-dose; 30 and 45 minutes; and 1, 2, 4, 8, 24, and 30 hours. ]Area under the curve (AUC) of oxaliplatin for patients with peritoneal carcinomatosis after PIPAC administration.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03172416
|Contact: Jimmy So, MBChB||+65 6772 5555 ext email@example.com|
|Contact: Guowei Kim, MBBS||+65 6772 5555 ext firstname.lastname@example.org|
|Principal Investigator:||Jimmy So, MBChB||National University Hospital, Singapore|