Xeloxiri as First-line Treatment in Patients With Advanced Unresectable Pancreatic Adenocarcinoma

May 6, 2017 updated by: Dr. YAU Chung Cheung Thomas, The University of Hong Kong

An Open-label, Single-centre, Single-arm Phase II Study of Capecitabine Combined With Oxaliplatin and Irinotecan (Xeloxiri) as First-line Treatment in Patients With Advanced Unresectable Pancreatic Adenocarcinoma

This is an open-label, single centre, single-arm phase II study which aims to assess the efficacy and tolerability of triplet combination of capecitabine, oxaliplatin and irinotecan (Xeloxiri regimen) in treating patients with advanced unresectable pancreatic carcinoma. Clinical data from patients diagnosed with pancreatic adenocarcinoma will be collected and analyzed in this study. The patients' data will be collected and maintained in the Division of Medical Oncology of the University Department of Medicine, Queen Mary Hospital, Hong Kong.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Queen Mary Hospital, The University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults ≥ 18 years of age, male or female.
  • Histopathologically or cytologically confirmed adenocarcinoma of the pancreas.
  • ECOG performance status 0 to 2.
  • Adequate bone marrow reserve.
  • Absolute neutrophil count > 1x10^9/L.
  • Total bilirubin <3 times the upper limit of the normal range.
  • Life expectancy ≥ 12 weeks.
  • Signed written informed consent form.

Exclusion Criteria:

  • Prior malignant disease other than pancreatic cancer.
  • Patients suitable for surgical or locoregional therapies.
  • Patients who have prior anticancer therapy for pancreatic cancer.
  • Patients unable to swallow oral medications.
  • Any evidence of brain metastasis (unless the patient is >6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry).
  • Active clinically serious infections (> grade 2 NCI / CTC Adverse Event version 3.0).
  • History of allergy to platinum compounds.
  • Patients who have chronic inflammatory bowel disease and/or bowel obstruction.
  • Patients who have severe bone marrow failure.
  • Patients undergoing renal dialysis.
  • History of HIV infection.
  • Seizure disorder requiring medication (such as steroids or anti-epileptics).
  • Women who are pregnant or breast-feeding, or women of child-bearing potential who are unable or unwilling to practice a highly effective means of contraception.
  • Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of study results.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Arm 1
Drug: Capecitabine
1200 mg/m2 BD orally for 1 week of a 2-week cycle (i.e. 1 week on, 1 week off)
Other Names:
  • Xeloda
Drug: Oxaliplatin
70 mg/m2 IV on day 1 of a 2-week cycle
Drug: Irinotecan
130 mg/m2 IV on day 1 of a 2-week cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in extent of disease
Time Frame: Change from baseline in size approximately every 4 cycles
Objective response rate
Change from baseline in size approximately every 4 cycles

Secondary Outcome Measures

Outcome Measure
Time Frame
CA19.9 reduction
Time Frame: Change from baseline every 2 cycles
Change from baseline every 2 cycles
Progression-free survival
Time Frame: From date of start until the date of first documented progression or death from disease-related causes or last follow-up, whichever came first, assessed up to 18 months
From date of start until the date of first documented progression or death from disease-related causes or last follow-up, whichever came first, assessed up to 18 months
Overall survival
Time Frame: From date of start until the date of death from any cause or last follow-up, whichever came first, assessed up to 18 months
From date of start until the date of death from any cause or last follow-up, whichever came first, assessed up to 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (ACTUAL)

December 1, 2016

Study Completion (ACTUAL)

December 1, 2016

Study Registration Dates

First Submitted

March 18, 2012

First Submitted That Met QC Criteria

March 18, 2012

First Posted (ESTIMATE)

March 20, 2012

Study Record Updates

Last Update Posted (ACTUAL)

May 9, 2017

Last Update Submitted That Met QC Criteria

May 6, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MONC-HBP24

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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