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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

Phase 2
18 Years
75 Years
Open (Enrolling)
Pancreatic Adenocarcinoma

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Trial Information

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

Pancreatic cancer carries extremely dismal overall prognosis that its motality was almost
the same as its incidence in 2008.[1] Pancreatic adenocarcinoma is the commonest type of
pancreatic cancer and was the fourth leading cause of cancer death in the United States in
2010.[2] For all stages combined, the 1- and 5-year relative survival rates are 26% and 6%,
respectively. Even for those people diagnosed with local disease, the 5-year survival is
only 23%.[3]

Gemcitabine (Gemzar®; Eli Lilly) has become the reference regimen for advanced pancreatic
cancer after a randomized trial showed significant improvement in overall survival as
compared with fluorouracil (5-FU) administered as an intravenous bolus.[4] Capecitabine
(Xeloda®; Roche) is an oral fluoropyrimidine carbamate prodrug designed to generate 5-FU
preferentially in tumor cells due to high concentration level of thymidine phosphorylase
enzyme. This allows to mimic continuous 5-FU infusion at the tumor site and to reduce
exposure of adjacent healthy tissues without causing discomfort and complications related to
intravenous (IV) administration.[5] It has been widely used for the treatment of colorectal
cancers and breast cancer.

Irinotecan (Campto®; Pfizer) has some clinical activity against advanced pancreatic cancer.
Preclinical studies have indicated that irinotecan has synergistic activity when it is
administered before 5-FU and leucovorin. Oxaliplatin (Eloxatin®; sanofi-aventis) has
clinical activity against pancreatic cancer only when combined with 5-FU. Oxaliplatin and
irinotecan show synergistic activity in vitro.[6]

A recent randomized controlled trial demonstrated that a combination of 5-FU, leucovorin,
irinotecan and oxaliplatin (Folfirinox regimen) was associated with a survival advantage and
had increased toxicity as compared to single-agent gemcitabine in pancreatic cancer
patients.[6] Another recent phase I trial showed promising results of the combination of
capecitabine, oxaliplatin and irinotecan in metastatic colorectal cancer subjects and
suggested that this tritherapy may provide valuable therapeutic alternative, especially in
patients with gastrointestinal cancer.[5]

Therefore, it is of interest to explore the possibility to replace IV 5-FU and leucovorin in
the Folfirinox regimen with capecitabine and to assess the efficacy and tolerability of this
modified regimen in treating patients with advanced unresectable pancreatic carcinoma.

Inclusion Criteria:

- Adults ≥ 18 and < 75 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.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Change in extent of disease

Outcome Description:

Objective response rate

Outcome Time Frame:

Change from baseline in size approximately every 4 cycles

Safety Issue:


Principal Investigator

Thomas Yau, MBBS

Investigator Role:

Principal Investigator

Investigator Affiliation:

The University of Hong Kong


Hong Kong: Institutional Review Board of the University of Hong Kong/ Hospital Authority Hong Kong West Cluster

Study ID:




Start Date:

April 2012

Completion Date:

Related Keywords:

  • Pancreatic Adenocarcinoma
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous