Overview

This trial is active, not recruiting.

Condition pancreatic adenocarcinoma
Treatments capecitabine, oxaliplatin, irinotecan
Phase phase 2
Sponsor The University of Hong Kong
Start date April 2012
End date December 2016
Trial size 29 participants
Trial identifier NCT01558869, MONC-HBP24

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
capecitabine Xeloda
1200 mg/m2 BD orally for 1 week of a 2-week cycle (i.e. 1 week on, 1 week off)
oxaliplatin
70 mg/m2 IV on day 1 of a 2-week cycle
irinotecan
130 mg/m2 IV on day 1 of a 2-week cycle

Primary Outcomes

Measure
Change in extent of disease
time frame: Change from baseline in size approximately every 4 cycles

Secondary Outcomes

Measure
CA19.9 reduction
time frame: 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
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

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title 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
Principal investigator Thomas Yau, MD
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by The University of Hong Kong.