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Metastatic Pancreatic AdenocarcinomaPhase 2ALIXNCT03974854

Evaluation of Polychemotherapy With XELOXIRI-3 in Elderly or Frail Patients With Advanced Pancreatic Adenocarcinoma

A Phase 2 study testing XELOXIRI-3 and Gemcitabine in people with Metastatic Pancreatic Adenocarcinoma, run by Centre Hospitalier Universitaire de Besancon at 5 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Current standard of care for patients with metastatic Pancreatic Ductal AdenoCarcinoma (PDAC) is chemotherapy, preferential regimen being FOLFIRINOX (5-fluorouracil, leucovorin, irinotecan, and oxaliplatin). Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Metastatic Pancreatic Adenocarcinoma
What is being tested?
XELOXIRI-3 and Gemcitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
5 sitesFrance
Study dates
8 Jul 2019to 1 Feb 2024
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 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Main Inclusion Criteria :

  • Histologically proven pancreatic ductal adenocarcinoma
  • Locally Advanced or metastatic disease
  • Measurable disease according to RECIST v1.1 criteria
  • Age ≥ 75 years;

OR age between 65 and 75 years AND with at least one frailty contraindication to the administration of chemotherapy with FOLFIRINOX:

  • Eastern Cooperative Oncology Group Performance status (ECOG-PS) 2
  • Total serum bilirubin > 1.5 ULN (biliary drainage allowed)
  • Clinico-biological frailty criteria:
  • weight loss > 10% in 6 months or > 5% in 1 month
  • or body mass index (BMI) ≤ 21
  • or serum albumin < 30 g/L
  • or ADL (Activities of Daily Living) score < 6
  • Eligible for gemcitabine as first-line chemotherapy
  • Registration in a national health care system
  • Written informed consent obtained from the patient prior to performing any protocol-related procedures

Main Exclusion Criteria:

  • Age < 65 years
  • Localized non-metastatic cancer
  • ECOG-PS 3-4
  • Previous treatment For advanced stage (locally advanced or metastatic): chemotherapy, radiochemotherapy; For localized stage: FOLFIRINOX chemotherapy (neoadjuvant or adjuvant); adjuvant chemotherapy with gemcitabine before relapse is permitted (provide it has been administered more than 6 months before)
  • Uncontrolled intercurrent cardiovascular disease
  • Known or suspected allergy or hypersensitivity to any of the study drugs (capecitabine, oxaliplatin, irinotecan, gemcitabine)
  • Bowel obstruction or sub-obstruction or impossible oral treatment
  • Prior peripheral neuropathy of grade ≥ 2
  • Known complete dihydropyrimidine dehydrogenase (DPD) or UDP-glycosyltransferase 1 polypeptide A1 (UGT1A1) deficiency
  • Inadequate hematological, hepatic, and renal functions
  • Psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs (Adverse Events) or compromise the ability of the patient to give written informed consent
  • Tutelage or guardianship
  • Diagnosis of any second malignancy within the last 2 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ carcinoma of the cervix uteri
  • Current participation in another clinical trial using therapeutic experimental agents

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

France5 sites

  • University Hospital of Besançon

    Besançon

  • Hôpital Nord Franche-Comté

    Montbéliard

  • CH Mulhouse

    Mulhouse

  • CHU Nancy

    Nancy

  • CHU Reims

    Reims

Other trials in France

About this study

Official title: Evaluation of Polychemotherapy With XELOXIRI-3 in Elderly or Frail Patients With Advanced Pancreatic Adenocarcinoma (ALIX)

Current standard of care for patients with metastatic Pancreatic Ductal AdenoCarcinoma (PDAC) is chemotherapy, preferential regimen being FOLFIRINOX (5-fluorouracil, leucovorin, irinotecan, and oxaliplatin). Due to more hematologic (neutropenia) and gastrointestinal toxicities, FOLFIRINOX is only administered in fit patients (age < 75 years, ECOG Performance status 0-1, and bilirubin < 1.5 ULN).

However, elderly or frail patients represent more than half of patients with PDAC and are treated with gemcitabine monochemotherapy. Maintaining more than one drug (polychemotherapy) may improve survival and quality of life in this population.

ALIX is a non-comparative randomized 2:1 phase II study. This study will assess the efficacy and safety of the polychemotherapy with XELOXIRI-3 versus gemcitabine as first-line chemotherapy in elderly or frail patients with locally advanced or metastatic PDAC.

Being tested
XELOXIRI-3, Gemcitabine

What participants receive

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

  • XELOXIRI-3Drug

    Also called Capecitabine, Oxaliplatine, Irinotecan

    chemotherapy with XELOXIRI-3 regimen

  • GemcitabineDrug

    chemotherapy with Gemcitabine regimen

Study groups in NCT03974854
Study groupRoleWhat they receive
Arm A: XELOXIRI-3Experimentalcapecitabine 625 mg/m2 twice daily on days 1-7 oxaliplatine 85 mg/m2 on Day 1 irinotecan 90 mg/m2 on Day 3, every 14 days
Receives: Drug: XELOXIRI-3
Arm B: GemcitabineActive comparator1000 mg / m2 on D1, D8 and D15, every 28 days
Receives: Drug: Gemcitabine

What is being measured

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

  1. 6 months Progression-Free Survival (PFS) rate

    Measured: 6 months after the date of initiation of treatment (1st day of 1st cycle of chemotherapy)

Timeline

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

  1. First posted5 Jun 2019
  2. Study start8 Jul 2019
  3. Primary completion1 Aug 2023
  4. Study completion1 Feb 2024

Why it stopped: sponsor decision

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03974854
Sponsor's protocol ID
P/2018/395
Acronym
ALIX
Status last verified
Dec 2024
First submitted
3 Jun 2019
Last updated
27 Dec 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing XELOXIRI-3 and Gemcitabine in people with Metastatic Pancreatic Adenocarcinoma, run by Centre Hospitalier Universitaire de Besancon at 5 sites in France.

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

Who may be eligible to take part?

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: stopped early, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in France. 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 was stopped early (reason given: sponsor decision). Results are not available in the source record.

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?

6 months Progression-Free Survival (PFS) rate (time frame: 6 months after the date of initiation of treatment (1st day of 1st cycle of chemotherapy)). 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 NCT03974854.

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 27 Dec 2024.

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