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Gemcitabine and Paclitaxel vs Gemcitabine Alone After FOLFIRINOX Failure in Metastatic Pancreatic Ductal Adenocarcinoma (GEMPAX)

Primary Purpose

Metastatic Pancreatic Adenocarcinoma

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Gemcitabine
Paclitaxel
Sponsored by
UNICANCER
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Pancreatic Adenocarcinoma focused on measuring Metastatic Pancreas Ductal Adenocarcinoma

Eligibility Criteria

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

Inclusion Criteria:

  • Metastatic Pancreatic Ductal Adenocarcinoma with histological or cytological proof
  • Age ≥18 years
  • At least 1 evaluable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 outside any previously irradiated area
  • Failure of first line FOLFIRINOX (Progressive disease during therapy of within 3 months +/- 15 days)
  • Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2
  • Life expectancy ≥12 weeks
  • Negative serology (HIV, hepatitis B and C)
  • Adequate organs function
  • Proven Post-menopausal status or negative urinary or serum pregnancy test
  • Woman of childbearing potential and male patients must agree to use adequate contraception fo the duration of the trial and up to 6 months after completing treatment
  • Patients affiliated to the social security system
  • Patient must have signed a written informed consent form

Exclusion Criteria:

  • Any other primary tumor or secondary malignancy except basal cell carcinoma of skin or in situ carcinoma of the cervix uteri
  • Known cerebral metastasis
  • Uncontrolled severe infections
  • Patients with Kaposi's sarcoma
  • Peripheral neuropathy exceeding grade 2 on Common Terminology Criteria for Adverse Events (CTCAE) v5.0
  • Previous treatment with taxane and/or gemcitabine (for pancreas cancer only)
  • Patients with known allergy or severe hypersensitivity to any trial drug or drug excipient
  • Patients with any other disease or illness which requires hospitalisation or is incompatible with the trial treatment
  • Patients unable to comply with trial obligations for geographic, social or physical reasons, or who are unable to understand the purpose and procedures of the trial
  • Participation in another clinical trial within 14 days prior to randomization
  • Patients deprived of liberty or under legal protection measures or patients whose willingness to participate in the trial may be unduly influenced

Sites / Locations

  • CH de Bayeux
  • CH Simone Veil
  • CHU Jean Minjoz
  • Hôpital Duchenne
  • CH du Cotentin
  • Centre Georges François Leclerc
  • Centre Léon Bérard
  • Hospices civils de Lyon
  • CHU La Timone
  • Hôpital Européen de Marseille
  • Hôpital Saint-Joseph
  • Institut Paoli Calmettes
  • Hôpital Nord Franche Comté
  • Centre Antoine Lacassagne
  • Hôpital Saint-Louis
  • Institut Mutualiste Montsouris
  • Hôpital Pitié-Salpétrière
  • Institut Godinot
  • Centre Eugène Marquis
  • CHU Rouen
  • Institut Curie
  • Institut de Cancérologie de l'Ouest
  • Hôpital Broussais
  • CHU de Saint-Etienne
  • Hôpital Trousseau
  • Institut Gustave Roussy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

GEMPAX

Control

Arm Description

Gemcitabine + Paclitaxel until progression

Gemcitabine alone until progression

Outcomes

Primary Outcome Measures

Overall Survival
Time from the date of randomization to the date of death from any cause

Secondary Outcome Measures

Full Information

First Posted
May 7, 2019
Last Updated
May 17, 2022
Sponsor
UNICANCER
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1. Study Identification

Unique Protocol Identification Number
NCT03943667
Brief Title
Gemcitabine and Paclitaxel vs Gemcitabine Alone After FOLFIRINOX Failure in Metastatic Pancreatic Ductal Adenocarcinoma
Acronym
GEMPAX
Official Title
A Phase III Randomized Study Evaluating Gemcitabine and Paclitaxel Versus Gemcitabine Alone After FOLFIRINOX Failure or Intolerance in Metastatic Pancreatic Ductal Adenocarcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
May 23, 2019 (Actual)
Primary Completion Date
April 26, 2022 (Actual)
Study Completion Date
April 26, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNICANCER

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study aims to evaluate whether the combination of gemcitabine and paclitaxel allows to improve the overall survival compared to gemcitabine alone, in patients with metastatic Pancreatic Ductal Adenocarcinoma (PDAC) after FOLFIRINOX failure or intolerance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Pancreatic Adenocarcinoma
Keywords
Metastatic Pancreas Ductal Adenocarcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
211 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GEMPAX
Arm Type
Experimental
Arm Description
Gemcitabine + Paclitaxel until progression
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Gemcitabine alone until progression
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
GEMZAR
Intervention Description
1000 mg/m² in IV infusion over 30-40 minutes at Day 1, 8 and 15 followed by one week of rest.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
TAXOL
Intervention Description
80 mg/m² in IV infusion over 60 minutes at Day 1, 8 and 15 followed by 1 week of rest.
Primary Outcome Measure Information:
Title
Overall Survival
Description
Time from the date of randomization to the date of death from any cause
Time Frame
Until death (life expectancy around 12 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Metastatic Pancreatic Ductal Adenocarcinoma with histological or cytological proof Age ≥18 years At least 1 evaluable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 outside any previously irradiated area Failure of first line FOLFIRINOX (Progressive disease during therapy of within 3 months +/- 15 days) Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2 Life expectancy ≥12 weeks Negative serology (HIV, hepatitis B and C) Adequate organs function Proven Post-menopausal status or negative urinary or serum pregnancy test Woman of childbearing potential and male patients must agree to use adequate contraception fo the duration of the trial and up to 6 months after completing treatment Patients affiliated to the social security system Patient must have signed a written informed consent form Exclusion Criteria: Any other primary tumor or secondary malignancy except basal cell carcinoma of skin or in situ carcinoma of the cervix uteri Known cerebral metastasis Uncontrolled severe infections Patients with Kaposi's sarcoma Peripheral neuropathy exceeding grade 2 on Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Previous treatment with taxane and/or gemcitabine (for pancreas cancer only) Patients with known allergy or severe hypersensitivity to any trial drug or drug excipient Patients with any other disease or illness which requires hospitalisation or is incompatible with the trial treatment Patients unable to comply with trial obligations for geographic, social or physical reasons, or who are unable to understand the purpose and procedures of the trial Participation in another clinical trial within 14 days prior to randomization Patients deprived of liberty or under legal protection measures or patients whose willingness to participate in the trial may be unduly influenced
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christelle de la FOUCHARDIERE, Dr
Organizational Affiliation
UNICANCER
Official's Role
Principal Investigator
Facility Information:
Facility Name
CH de Bayeux
City
Bayeux
Country
France
Facility Name
CH Simone Veil
City
Beauvais
Country
France
Facility Name
CHU Jean Minjoz
City
Besançon
Country
France
Facility Name
Hôpital Duchenne
City
Boulogne-sur-Mer
Country
France
Facility Name
CH du Cotentin
City
Cherbourg
Country
France
Facility Name
Centre Georges François Leclerc
City
Dijon
Country
France
Facility Name
Centre Léon Bérard
City
Lyon
Country
France
Facility Name
Hospices civils de Lyon
City
Lyon
Country
France
Facility Name
CHU La Timone
City
Marseille
Country
France
Facility Name
Hôpital Européen de Marseille
City
Marseille
Country
France
Facility Name
Hôpital Saint-Joseph
City
Marseille
Country
France
Facility Name
Institut Paoli Calmettes
City
Marseille
Country
France
Facility Name
Hôpital Nord Franche Comté
City
Montbéliard
Country
France
Facility Name
Centre Antoine Lacassagne
City
Nice
Country
France
Facility Name
Hôpital Saint-Louis
City
Paris
ZIP/Postal Code
75011
Country
France
Facility Name
Institut Mutualiste Montsouris
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Hôpital Pitié-Salpétrière
City
Paris
Country
France
Facility Name
Institut Godinot
City
Reims
Country
France
Facility Name
Centre Eugène Marquis
City
Rennes
Country
France
Facility Name
CHU Rouen
City
Rouen
Country
France
Facility Name
Institut Curie
City
Saint-Cloud
Country
France
Facility Name
Institut de Cancérologie de l'Ouest
City
Saint-Herblain
Country
France
Facility Name
Hôpital Broussais
City
Saint-Malo
Country
France
Facility Name
CHU de Saint-Etienne
City
Saint-Étienne
Country
France
Facility Name
Hôpital Trousseau
City
Tours
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
21561347
Citation
Conroy T, Desseigne F, Ychou M, Bouche O, Guimbaud R, Becouarn Y, Adenis A, Raoul JL, Gourgou-Bourgade S, de la Fouchardiere C, Bennouna J, Bachet JB, Khemissa-Akouz F, Pere-Verge D, Delbaldo C, Assenat E, Chauffert B, Michel P, Montoto-Grillot C, Ducreux M; Groupe Tumeurs Digestives of Unicancer; PRODIGE Intergroup. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011 May 12;364(19):1817-25. doi: 10.1056/NEJMoa1011923.
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Gemcitabine and Paclitaxel vs Gemcitabine Alone After FOLFIRINOX Failure in Metastatic Pancreatic Ductal Adenocarcinoma

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