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Trial record 10 of 1990 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

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.

Condition or disease Intervention/treatment Phase
Peritoneal Carcinomatosis Drug: Oxaliplatin Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Oxaliplatin

Arm Intervention/treatment
3+3 dose escalation of PIPAC using oxaloplatin 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.





Primary Outcome Measures :
  1. Safety Profile of PIPAC with oxaliplatin by monitoring adverse event profile of patient undergo PIPAC [ Time Frame: 1 to 2 years ]
  2. Tolerability of PIPAC with oxaliplatin by monitoring dose limiting toxicities. [ Time Frame: 1-2 years ]

Secondary Outcome Measures :
  1. Clinical response of PIPAC with oxaliplatin according to Peritoneal Cancer Index (PCI) [ Time Frame: 1-2 years ]
  2. Pathological response of PIPAC with oxaliplatin according to Peritoneal Regression Grade Scoring (PRGS) System [ Time Frame: 1-2 years ]
  3. 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.

  4. 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.

  5. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Jimmy So, MBChB +65 6772 5555 ext 24236 sursbyj@nus.edu.sg
Contact: Guowei Kim, MBBS +65 6772 5555 ext 23880 guo_wei_kim@nuhs.edu.sg

Locations
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Singapore
National University Hospital Recruiting
Singapore, Singapore, 119228
Contact: Jimmy So, MBChB    +65 6772 5555 ext 24236    sursbyj@nus.edu.sg   
Contact: Guowei Kim, MBBS    +65 6772 5555 ext 28830    guo_wei_kim@nuhs.edu.sg   
Sponsors and Collaborators
National University Hospital, Singapore
Investigators
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Principal Investigator: Jimmy So, MBChB National University Hospital, Singapore

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT03172416     History of Changes
Other Study ID Numbers: DSRB 2016/01088
First Posted: June 1, 2017    Key Record Dates
Last Update Posted: June 1, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by National University Hospital, Singapore:
Gastric Cancer
Unresectable Peritoneal Carcinomatosis
Oxaliplatin
Pressurized intraperitoneal aerosol chemotherapy
Additional relevant MeSH terms:
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Oxaliplatin
Carcinoma
Peritoneal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Abdominal Neoplasms
Neoplasms by Site
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Antineoplastic Agents