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Pancreatic CancerPhase 1OXIRINCT02368860

OXIRI [Oxaliplatin (O), Xeloda (X) and Irinotecan (I)] in Pancreatic Adenocarcinoma

A Phase 1 study testing oxaliplatin, irinotecan, capecitabine in people with Pancreatic Cancer, run by National Cancer Centre, Singapore at 1 site in Singapore.

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 exploratory Phase I study is to assess the safety and tolerability of the OXIRI regimen [oxaliplatin (O), xeloda (X) and irinotecan (I)] and to evaluate for preliminary evidence of efficacy, in patients with advanced and/or metastatic pancreatic adenocarcinoma. Read more about this study

Who is it for?
Ages 21 to 75 years
Conditions the study is for
Pancreatic Cancer
What is being tested?
oxaliplatin, irinotecan, capecitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
1 siteSingapore
Study dates
17 Sep 2013to 21 May 2020
Phase
Phase 1
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 21 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients between 21 to 75 years of age
  • A histopathologically or cytological confirmed diagnosis of locally advanced and/or metastatic PDAC that is unresectable
  • Measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) ver 1.1 criteria
  • Life expectancy of at least 12 weeks
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • Adequate hematologic function (neutrophils count ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L)
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  • Adequate hepatic function (total bilirubin ≤ 1.5 x the upper limits of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x ULN
  • Adequate renal function (calculated creatinine clearance > 50 mL/min)
  • Able to give informed consent
  • Toxicity related to previous radiotherapy or chemotherapy resolved to ≤ Grade 1

Who cannot join

  • History of prior malignancy except non-melanoma skin cancer within the last 5yrs
  • Uncontrolled central nervous system (CNS) metastases or carcinomatous meningitis
  • Uncontrolled concomitant medical illnesses (e.g. hypertension, myocardial infarct, heart failure, ventricular arrhythmia, diabetes, severe infection)
  • Major surgery within four weeks prior to study treatment
  • Patients on chronic immunosuppressive therapy
  • Pregnant or breast-feeding female patients
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  • On anticoagulant therapy with vitamin K antagonists.
  • Dose-escalation cohort:
  • Patients homozygous for uridine diphosphate glucuronosyltransferase (UGT)1A1*6/*6 or UGT1A1*28/*28
  • Previous oxaliplatin or irinotecan chemotherapy
  • Treatment with any of the following anti-cancer therapies prior to the first dose of OXIRI within the stated timeframes
  • Cyclical chemotherapy within a period of time that is shorter than the cycle length used for that treatment. Exception for weekly chemotherapy regimens, where a minimum of 2 week washout from the last dose is required.
  • Biological therapy (e.g., antibodies) within a period of time that is ≤ 5 t1/2 or ≤ 4 weeks, whichever is shorter, prior to starting study drug
  • Continuous or intermittent small molecule therapeutics within a period of time that is ≤ 5 t1/2 or ≤ 4 weeks (whichever is shorter) prior to starting study drug
  • Any other investigational agents within a period of time that is ≤ 5 t1/2 or less than the cycle length used for that treatment or ≤ 4 weeks (whichever is shortest) prior to starting study drug
  • Wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting study drug
  • Dose-expansion cohort:
  • Previous chemotherapy or radiotherapy

Trial locations and contacts

1 site in 1 country.

Singapore1 site

  • National Cancer Centre

    Singapore, 169610

Other trials in Singapore

About this study

Official title: Phase I Trial of OXIRI [Oxaliplatin (O), Xeloda (X) and Irinotecan (I)] Treatment in Patients With Advanced and/or Metastatic Pancreatic Adenocarcinoma

This is an exploratory Phase I study is to assess the safety and tolerability of the OXIRI regimen [oxaliplatin (O), xeloda (X) and irinotecan (I)] and to evaluate for preliminary evidence of efficacy, in patients with advanced and/or metastatic pancreatic adenocarcinoma. The investigators hypothesize that 2 of 3 weekly doses of oxaliplatin and genotype directed-dosing of irinotecan in combination with chronomodulated capecitabine (xeloda) administered continuously will be more tolerable than the FOLFIRINOX regimen (folinic acid, fluorouracil, irinotecan and oxaliplatin) while maintaining anti-tumour activity.

Read the detailed description

This study comprises a dose escalation phase using 3+3 design to determine the safety, tolerability and pharmacokinetics of the OXIRI regimen and an expansion phase to further evaluate the MTD and to determine early signs of efficacy.

Eligible patients will receive a novel chemotherapeutic regimen (OXIRI regimen) with xeloda being administered in a chronomodulated fashion and the dose of irinotecan being guided by the UGT1A1*28 and UGT1A1*6 genotype status of the patient.

Being tested
oxaliplatin, irinotecan, capecitabine
Medical subject headings
Pancreatic Neoplasms

What participants receive

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

  • oxaliplatin, irinotecan, capecitabineDrug

    Also called Eloxatin, Camptosar, CPT-11, Xeloda

    fixed doses of intravenous oxaliplatin 50 mg/m2, and intravenous irinotecan administered on days 1 and 8 in a 21 day-cycle while xeloda will be administered daily at around midnight from day 1 to day 14

Study groups in NCT02368860
Study groupRoleWhat they receive
OXIRIExperimentalOXIRI regimen: oxaliplatin, irinotecan, capecitabine
Receives: Drug: oxaliplatin, irinotecan, capecitabine

What is being measured

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

  1. Safety and tolerability of the OXIRI regimen as measured by the frequency of significant adverse events incurred by the participants, using CTCAE ver. 4 grading system

    The safety and tolerability of the regimen will be assessed when the patient is on treatment and till 30 days after treatment.

    Measured: from first dose to 30 days after last dose

Secondary outcomes (5)

  1. Maximum tolerated dose (MTD) of capecitabine when administered in a continuous chronomodulated fashion with genotype-directed dosing of irinotecan and metronomic dosing of oxaliplatin, using a conventional 3+3 design

    Measured: 2 years

  2. Recommended Phase II dose (RP2D) of the OXIRI regimen which is the MTD

    Measured: 2 years

  3. Pharmacokinetics analysis of capecitabine

    Plasma level of capecitabine, its intermediary metabolites (5'-deoxy-5-fluorocytidine [DFCR] and 5'- deoxy-5- fluorouridine [DFUR]) and 5FU will be measured at multiple time points on C1D1

    Measured: cycle 1 day 1

  4. Pharmacokinetics analysis of Irinotecan

    Plasma level of Irinotecan, SN-38 (active metabolite of irinotecan) and SN-38G will be measured at multiple time points on C1D1

    Measured: cycle 1 day 1

  5. Efficacy of OXIRI as measured by response evaluation criteria in solid tumours (RECIST) version 1.1

    Measured: 3 years

Timeline

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

  1. First posted23 Feb 2015 (estimated)
  2. Study start17 Sep 2013
  3. Primary completion21 May 2020
  4. Study completion21 May 2020

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02368860
Sponsor's protocol ID
NCC-13-01
Acronym
OXIRI
Status last verified
May 2021
First submitted
29 Jan 2015
Last updated
1 Jun 2021
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing oxaliplatin, irinotecan, capecitabine in people with Pancreatic Cancer, run by National Cancer Centre, Singapore at 1 site in Singapore.

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 10 inclusion and 18 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 1 Jun 2021. 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 Singapore. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Safety and tolerability of the OXIRI regimen as measured by the frequency of significant adverse events incurred by the participants, using CTCAE ver. 4 grading system (time frame: from first dose to 30 days after last dose). 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 NCT02368860.

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 1 Jun 2021; AzTrials last refreshed its copy on 8 Nov 2026.

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