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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

Tracking Information
First Submitted Date  ICMJE June 3, 2019
First Posted Date  ICMJE June 5, 2019
Last Update Posted Date June 5, 2019
Estimated Study Start Date  ICMJE July 2019
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 3, 2019)
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) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Polychemotherapy With XELOXIRI-3 in Elderly or Frail Patients With Metastatic Pancreatic Adenocarcinoma
Official Title  ICMJE Evaluation of Polychemotherapy With XELOXIRI-3 in Elderly or Frail Patients With Metastatic Pancreatic Adenocarcinoma (ALIX)
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Pancreatic Adenocarcinoma
Intervention  ICMJE
  • Drug: XELOXIRI-3
    chemotherapy with XELOXIRI-3 regimen
    Other Names:
    • Capecitabine
    • Oxaliplatine
    • Irinotecan
  • Drug: Gemcitabine
    chemotherapy wth Gemcitabine regimen
Study Arms  ICMJE
  • 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
    Intervention: Drug: XELOXIRI-3
  • Active Comparator: Arm B: Gemcitabine
    1000 mg / m2 on D1, D8 and D15, every 28 days
    Intervention: Drug: Gemcitabine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 3, 2019)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2022
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Angélique Dr VIENOT +33381479999 a3vienot@chu-besancon.fr
Contact: Marion JACQUIN m1jacquin@chu-besancon.fr
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03974854
Other Study ID Numbers  ICMJE P/2018/395
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Centre Hospitalier Universitaire de Besancon
Study Sponsor  ICMJE Centre Hospitalier Universitaire de Besancon
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Angélique VIENOT, Dr University Hospital of Besançon
PRS Account Centre Hospitalier Universitaire de Besancon
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP