Back to resultsXeloxiri as First-line Treatment in Patients With Advanced Unresectable Pancreatic Adenocarcinoma
Primary Purpose
Pancreatic Adenocarcinoma
Status
Completed
Phase
Phase 2
Locations
Hong Kong
Study Type
Interventional
Intervention
Capecitabine
Oxaliplatin
Irinotecan
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Adenocarcinoma
Eligibility Criteria
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.
Sites / Locations
- Queen Mary Hospital, The University of Hong Kong
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm 1
Arm Description
Outcomes
Primary Outcome Measures
Change in extent of disease
Objective response rate
Secondary Outcome Measures
CA19.9 reduction
Progression-free survival
Overall survival
Full Information
NCT ID
NCT01558869
First Posted
March 18, 2012
Last Updated
May 6, 2017
Sponsor
The University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT01558869
Brief Title
Xeloxiri as First-line Treatment in Patients With Advanced Unresectable Pancreatic Adenocarcinoma
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Adenocarcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Other Intervention Name(s)
Xeloda
Intervention Description
1200 mg/m2 BD orally for 1 week of a 2-week cycle (i.e. 1 week on, 1 week off)
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
70 mg/m2 IV on day 1 of a 2-week cycle
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Intervention Description
130 mg/m2 IV on day 1 of a 2-week cycle
Primary Outcome Measure Information:
Title
Change in extent of disease
Description
Objective response rate
Time Frame
Change from baseline in size approximately every 4 cycles
Secondary Outcome Measure Information:
Title
CA19.9 reduction
Time Frame
Change from baseline every 2 cycles
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Yau, MD
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Mary Hospital, The University of Hong Kong
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
Citations:
PubMed Identifier
21561347
Citation
Conroy T, Desseigne F, Ychou M, Bouche O, Guimbaud R, Becouarn Y, Adenis A, Raoul JL, Gourgou-Bourgade S, de la Fouchardiere C, Bennouna J, Bachet JB, Khemissa-Akouz F, Pere-Verge D, Delbaldo C, Assenat E, Chauffert B, Michel P, Montoto-Grillot C, Ducreux M; Groupe Tumeurs Digestives of Unicancer; PRODIGE Intergroup. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011 May 12;364(19):1817-25. doi: 10.1056/NEJMoa1011923.
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Xeloxiri as First-line Treatment in Patients With Advanced Unresectable Pancreatic Adenocarcinoma
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