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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01558869
First Posted: March 20, 2012
Last Update Posted: May 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. YAU Chung Cheung Thomas, The University of Hong Kong
  Purpose
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.

Condition Intervention Phase
Pancreatic Adenocarcinoma Drug: Capecitabine Drug: Oxaliplatin Drug: Irinotecan Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Dr. YAU Chung Cheung Thomas, The University of Hong Kong:

Primary Outcome Measures:
  • Change in extent of disease [ Time Frame: Change from baseline in size approximately every 4 cycles ]
    Objective response rate


Secondary Outcome Measures:
  • 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 ]

Enrollment: 37
Study Start Date: April 2012
Study Completion Date: December 2016
Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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): NCT01558869


Locations
Hong Kong
Queen Mary Hospital, The University of Hong Kong
Hong Kong, Hong Kong
Sponsors and Collaborators
The University of Hong Kong
Investigators
Principal Investigator: Thomas Yau, MD The University of Hong Kong
  More Information

Publications:
Responsible Party: Dr. YAU Chung Cheung Thomas, Clinical Assistant Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT01558869     History of Changes
Other Study ID Numbers: MONC-HBP24
First Submitted: March 18, 2012
First Posted: March 20, 2012
Last Update Posted: May 9, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Capecitabine
Oxaliplatin
Irinotecan
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors