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Evaluation of Polychemotherapy With XELOXIRI-3 in Elderly or Frail Patients With Metastatic Pancreatic Adenocarcinoma (ALIX)

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ClinicalTrials.gov Identifier: NCT03974854
Recruitment Status : Not yet recruiting
First Posted : June 5, 2019
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

Brief 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). 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 metastatic PDAC.


Condition or disease Intervention/treatment Phase
Metastatic Pancreatic Adenocarcinoma Drug: XELOXIRI-3 Drug: Gemcitabine Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Polychemotherapy With XELOXIRI-3 in Elderly or Frail Patients With Metastatic Pancreatic Adenocarcinoma (ALIX)
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Gemcitabine

Arm Intervention/treatment
Experimental: Arm A: XELOXIRI-3
capecitabine 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
Drug: XELOXIRI-3
chemotherapy with XELOXIRI-3 regimen
Other Names:
  • Capecitabine
  • Oxaliplatine
  • Irinotecan

Active Comparator: Arm B: Gemcitabine
1000 mg / m2 on D1, D8 and D15, every 28 days
Drug: Gemcitabine
chemotherapy wth Gemcitabine regimen




Primary Outcome Measures :
  1. 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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Main Inclusion Criteria :

  • Histologically proven pancreatic ductal adenocarcinoma
  • 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 or locally advanced 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03974854


Contacts
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Contact: Angélique Dr VIENOT +33381479999 a3vienot@chu-besancon.fr
Contact: Marion JACQUIN m1jacquin@chu-besancon.fr

Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Investigators
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Principal Investigator: Angélique VIENOT, Dr University Hospital of Besançon

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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT03974854     History of Changes
Other Study ID Numbers: P/2018/395
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gemcitabine
Capecitabine
Irinotecan
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Topoisomerase I Inhibitors
Topoisomerase Inhibitors