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Pancreatic AdenocarcinomaPhase 2NCT01558869

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

A Phase 2 study testing Capecitabine, Oxaliplatin and Irinotecan in people with Pancreatic Adenocarcinoma, run by The University of Hong Kong at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Adenocarcinoma
What is being tested?
Capecitabine, Oxaliplatin and Irinotecan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
1 siteHong Kong
Study dates
Apr 2012to Dec 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).
Show all 14Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

  • Queen Mary Hospital, The University of Hong Kong

    Hong Kong

Other trials in Hong Kong

About this study

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

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.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CapecitabineDrug

    Also called Xeloda

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

  • OxaliplatinDrug

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

  • IrinotecanDrug

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

Study groups in NCT01558869
Study groupRoleWhat they receive
Arm 1ExperimentalNot described
Receives: Drug: Capecitabine; Drug: Oxaliplatin; Drug: Irinotecan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in extent of disease

    Objective response rate

    Measured: Change from baseline in size approximately every 4 cycles

Secondary outcomes (3)

  1. CA19.9 reduction

    Measured: Change from baseline every 2 cycles

  2. Progression-free survival

    Measured: 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

  3. Overall survival

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2012 (estimated)
  2. Study startApr 2012
  3. Primary completionDec 2016
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01558869
Sponsor's protocol ID
MONC-HBP24
Status last verified
May 2017
First submitted
18 Mar 2012
Last updated
9 May 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 21561347

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Capecitabine, Oxaliplatin and Irinotecan in people with Pancreatic Adenocarcinoma, run by The University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in extent of disease (time frame: Change from baseline in size approximately every 4 cycles). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01558869, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2017.

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