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

Sponsor
The University of Hong Kong
Study ID
NCT01558869
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Capecitabine — DRUG
    1200 mg/m2 BD orally for 1 week of a 2-week cycle (i.e. 1 week on, 1 week off)
  • Oxaliplatin — DRUG
    70 mg/m2 IV on day 1 of a 2-week cycle
  • Irinotecan — DRUG
    130 mg/m2 IV on day 1 of a 2-week cycle

Study Details

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.

Key Dates

Start date
Apr 30, 2012
Status verified
May 2017
Primary completion
Dec 31, 2016
Completion
Dec 31, 2016

Study Design

Enrollment
37 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1

Primary Outcome Measure

Change in extent of disease [ Time Frame: Change from baseline in size approximately every 4 cycles ]

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