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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2016-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Pancreatic Adenocarcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

Group Type EXPERIMENTAL

Capecitabine

Intervention Type DRUG

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

Oxaliplatin

Intervention Type DRUG

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

Irinotecan

Intervention Type DRUG

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

Interventions

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Capecitabine

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

Intervention Type DRUG

Oxaliplatin

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

Intervention Type DRUG

Irinotecan

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

Intervention Type DRUG

Other Intervention Names

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Xeloda

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No