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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by The University of Hong Kong
Sponsor:
Information provided by (Responsible Party):
Dr. YAU Chung Cheung Thomas, The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01558869
First received: March 18, 2012
Last updated: May 6, 2014
Last verified: May 2014
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 The University of Hong Kong:

Primary Outcome Measures:
  • Change in extent of disease [ Time Frame: Change from baseline in size approximately every 4 cycles ] [ Designated as safety issue: No ]
    Objective response rate


Secondary Outcome Measures:
  • CA19.9 reduction [ Time Frame: Change from baseline every 2 cycles ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 29
Study Start Date: April 2012
Estimated Primary Completion Date: October 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01558869

Contacts
Contact: Thomas Yau, MD (852) 2255 3111 the@netvigator.com

Locations
Hong Kong
Queen Mary Hospital, The University of Hong Kong Recruiting
Hong Kong, Hong Kong
Contact: Thomas Yau       the@netvigator.com   
Principal Investigator: Thomas Yau, MD         
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
Study First Received: March 18, 2012
Last Updated: May 6, 2014
Health Authority: Hong Kong: Institutional Review Board of the University of Hong Kong/ Hospital Authority Hong Kong West Cluster
Hong Kong: Department of Health

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

ClinicalTrials.gov processed this record on August 26, 2014