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Trial record 10 of 2028 for:    oxaliplatin

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
Sponsor:
Information provided by (Responsible Party):
National University Hospital, Singapore

Tracking Information
First Submitted Date  ICMJE January 23, 2017
First Posted Date  ICMJE June 1, 2017
Last Update Posted Date June 1, 2017
Actual Study Start Date  ICMJE April 12, 2017
Estimated Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 29, 2017)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 29, 2017)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) With Oxaliplatin In Patients With Peritoneal Carcinomatosis
Official Title  ICMJE Phase 1 Study of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) With Oxaliplatin In Patients With Peritoneal Carcinomatosis
Brief Summary 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.
Detailed Description

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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Peritoneal Carcinomatosis
Intervention  ICMJE Drug: Oxaliplatin

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.

Study Arms  ICMJE 3+3 dose escalation of PIPAC using oxaloplatin
Intervention: Drug: Oxaliplatin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 29, 2017)
21
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2019
Estimated Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Gastric cancer patients with peritoneal metastasis on peritoneal cytology/histology.
  • Patients who refuse, are unable to tolerate, or have completed at least 1st line systemic chemotherapy.
  • Patients who have completed chemotherapy/targeted therapy > 21 days or at least 5 half-lives (or whichever is longer) prior to PIPAC.
  • Age >21 years.
  • Eastern Cooperative Oncology Group performance status 0-3.
  • Adequate bone marrow function (neutrophil count >1500/mm3, hemoglobin >8.0 g/dl and platelet count >100 000/mm3).
  • Adequate liver function (bilirubin, AST/ALT within upper limit of normal).
  • Adequate renal function (serum creatinine within the upper limit of normal).
  • Expected survival >3 months.
  • Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.

Exclusion Criteria:

  • Predominant extra-peritoneal metastases at the discretion of the study team after discussion at the multidisciplinary tumour board
  • Good response to systemic chemotherapy based on RECIST guidelines VI.I with complete or partial response to systemic chemotherapy.
  • Known allergy to oxaliplatin
  • Previous malignancy unrelated to current peritoneal carcinomatosis diagnosed in the last 5 years
  • Patients with reproductive potential who refuse to use an adequate means of contraception (including male patients)
  • Significant disease or conditions which, in the investigator's opinion, would exclude patient from the study
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant or lactating female
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03172416
Other Study ID Numbers  ICMJE DSRB 2016/01088
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party National University Hospital, Singapore
Study Sponsor  ICMJE National University Hospital, Singapore
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jimmy So, MBChB National University Hospital, Singapore
PRS Account National University Hospital, Singapore
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP