Back to results

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

Primary Purpose

Metastatic Pancreatic Adenocarcinoma

Status

Recruiting

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

XELOXIRI-3

Gemcitabine

About this trial

This is an interventional treatment trial for Metastatic Pancreatic Adenocarcinoma

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University Hospital of BesançonRecruiting
Hôpital Nord Franche-ComtéRecruiting
CH MulhouseRecruiting
CHU NancyRecruiting
CHU ReimsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A: XELOXIRI-3

Arm B: Gemcitabine

Arm Description

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

1000 mg / m2 on D1, D8 and D15, every 28 days

Outcomes

Primary Outcome Measures

6 months Progression-Free Survival (PFS) rate

Secondary Outcome Measures

Full Information

NCT ID

NCT03974854

First Posted

June 3, 2019

Last Updated

May 10, 2022

Sponsor

Centre Hospitalier Universitaire de Besancon

1. Study Identification

Unique Protocol Identification Number

NCT03974854

Brief Title

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

Acronym

ALIX

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Recruiting

Study Start Date

July 8, 2019 (Actual)

Primary Completion Date

February 2024 (Anticipated)

Study Completion Date

July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Universitaire de Besancon

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Pancreatic Adenocarcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm A: XELOXIRI-3

Arm Type

Experimental

Arm Description

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 Title

Arm B: Gemcitabine

Arm Type

Active Comparator

Arm Description

1000 mg / m2 on D1, D8 and D15, every 28 days

Intervention Type

Drug

Intervention Name(s)

XELOXIRI-3

Other Intervention Name(s)

Capecitabine, Oxaliplatine, Irinotecan

Intervention Description

chemotherapy with XELOXIRI-3 regimen

Intervention Type

Drug

Intervention Name(s)

Gemcitabine

Intervention Description

chemotherapy with Gemcitabine regimen

Primary Outcome Measure Information:

Title

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)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Angélique Dr VIENOT

Phone

+33381479999

a3vienot@chu-besancon.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Marion JACQUIN

m1jacquin@chu-besancon.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Angélique VIENOT, Dr

Organizational Affiliation

University Hospital of Besançon

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital of Besançon

City

Besancon

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Angelique VIENOT

First Name & Middle Initial & Last Name & Degree

Angélique VIENOT

Facility Name

Hôpital Nord Franche-Comté

City

Montbéliard

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Angelique VIENOT, Dr

First Name & Middle Initial & Last Name & Degree

Christophe BORG, Pr

Facility Name

CH Mulhouse

City

Mulhouse

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Stephanie HUSSON WETZEL

First Name & Middle Initial & Last Name & Degree

Stephanie HUSSON-WETZEL, Dr

Facility Name

CHU Nancy

City

Nancy

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anthony Lopez, Dr

First Name & Middle Initial & Last Name & Degree

Anthony LOPEZ, Dr

Facility Name

CHU Reims

City

Reims

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Olivier BOUCHE, Pr

First Name & Middle Initial & Last Name & Degree

Olivier BOUCHE, Pr

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs