Clinical trial NCT01558869: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Adenocarcinoma
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2012-03-20
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in extent of disease
timeFrame: Change from baseline in size approximately every 4 cycles
Secondary outcomes:
measure: CA19.9 reduction
timeFrame: Change from baseline every 2 cycles
measure: Progression-free survival
timeFrame: 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
measure: Overall survival
timeFrame: From date of start until the date of death from any cause or last follow-up, whichever came first, assessed up to 18 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital, The University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Thomas Yau, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.