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

Phase 2

Terminated

• Conditions: Metastatic Pancreatic Adenocarcinoma
• Interventions: Drug: XELOXIRI-3; Drug: Gemcitabine

• Registration Number: NCT03974854
• Lead Sponsor: 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 locally advanced or metastatic PDAC.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-06-03
• Study First Submitted QC: 2019-06-03
• Study First Posted: 2019-06-05
• Study Start: 2019-07-08
• Primary Completion: 2023-08-01
• Study Completion: 2024-02-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-23
• Last Update Posted: 2024-12-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A: XELOXIRI-3	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
Arm B: Gemcitabine	Gemcitabine	1000 mg / m2 on D1, D8 and D15, every 28 days

Primary Outcome Measures

Name	Time	Method
6 months Progression-Free Survival (PFS) rate	6 months after the date of initiation of treatment (1st day of 1st cycle of chemotherapy)

Trial Locations

Locations (5)

Hôpital Nord Franche-Comté; 🇫🇷 Montbéliard, France

CH Mulhouse; 🇫🇷 Mulhouse, France

University Hospital of Besançon; 🇫🇷 Besancon, France

CHU Reims; 🇫🇷 Reims, France

CHU Nancy; 🇫🇷 Nancy, France