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

NCT01558869 | Completed Phase 2

• 1 other identifier: MONC-HBP24
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Change in extent of disease

  Objective response rate

  Change from baseline in size approximately every 4 cycles

Secondary Outcomes (3)

• CA19.9 reduction

  Change from baseline every 2 cycles

• Progression-free survival

  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

  From date of start until the date of death from any cause or last follow-up, whichever came first, assessed up to 18 months

Study Arms (1)

Arm 1

EXPERIMENTAL

Drug: Capecitabine; Drug: Oxaliplatin; Drug: Irinotecan

Interventions

Capecitabine DRUG

1200 mg/m2 BD orally for 1 week of a 2-week cycle (i.e. 1 week on, 1 week off)

Also known as: Xeloda

Arm 1

Oxaliplatin DRUG

70 mg/m2 IV on day 1 of a 2-week cycle

Arm 1

Irinotecan DRUG

130 mg/m2 IV on day 1 of a 2-week cycle

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Queen Mary Hospital, The University of Hong Kong

Hong Kong, Hong Kong

Location

Related Publications (1)

• 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.

  PMID: 21561347 BACKGROUND

MeSH Terms

Interventions

Capecitabine; Oxaliplatin; Irinotecan

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals; Camptothecin; Alkaloids

Study Officials

• Thomas Yau, MD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: March 18, 2012
• First Posted: March 20, 2012
• Study Start: April 1, 2012
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: May 9, 2017

Record last verified: 2017-05

Locations

HK (1)