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

Metastatic Pancreatic Adenocarcinoma Clinical Trial

— ALIX  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03974854
• Other study ID #: P/2018/395
• Status: Terminated
• Phase: Phase 2
• Start date: July 8, 2019
• Est. completion date: February 1, 2024

Study information

• Verified date: January 2024
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: February 1, 2024
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Metastatic Pancreatic Adenocarcinoma

Intervention

Drug:
• XELOXIRI-3
chemotherapy with XELOXIRI-3 regimen
• Gemcitabine
chemotherapy with Gemcitabine regimen

Locations

Country	Name	City	State
France	University Hospital of Besançon	Besancon
France	Hôpital Nord Franche-Comté	Montbéliard
France	CH Mulhouse	Mulhouse
France	CHU Nancy	Nancy
France	CHU Reims	Reims

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6 months Progression-Free Survival (PFS) rate		6 months after the date of initiation of treatment (1st day of 1st cycle of chemotherapy)