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

January 13, 2026 updated by: UNICANCER

A Phase III Randomized Study Evaluating Gemcitabine and Paclitaxel Versus Gemcitabine Alone After FOLFIRINOX Failure or Intolerance in Metastatic Pancreatic Ductal Adenocarcinoma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

211

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bayeux, France
        • CH de Bayeux
      • Beauvais, France
        • CH Simone VEIL
      • Besançon, France
        • CHU Jean Minjoz
      • Boulogne-sur-Mer, France
        • Hôpital Duchenne
      • Cherbourg, France
        • CH du Cotentin
      • Dijon, France
        • Centre Georges Francois Leclerc
      • Lyon, France
        • Hospices Civils de Lyon
      • Lyon, France
        • Centre Leon Berard
      • Marseille, France
        • Institut Paoli Calmettes
      • Marseille, France
        • CHU La Timone
      • Marseille, France
        • Höpital Saint-Joseph
      • Marseille, France
        • Hôpital Européen de Marseille
      • Montbéliard, France
        • Hôpital Nord Franche Comté
      • Nice, France
        • Centre Antoine Lacassagne
      • Paris, France
        • Hôpital Pitié-Salpêtrière
      • Paris, France, 75014
        • Institut Mutualiste Montsouris
      • Paris, France, 75011
        • Hôpital Saint-Louis
      • Reims, France
        • Institut Godinot
      • Rennes, France
        • Centre Eugene Marquis
      • Rouen, France
        • CHU Rouen
      • Saint-Cloud, France
        • Institut Curie
      • Saint-Etienne, France
        • CHU de Saint-Etienne
      • Saint-Herblain, France
        • Institut de Cancérologie de l'Ouest
      • St-Malo, France
        • Hôpital Broussais
      • Tours, France
        • Hôpital Trousseau
      • Villejuif, France
        • Institut Gustave Roussy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GEMPAX
Gemcitabine + Paclitaxel until progression
Drug: Gemcitabine
1000 mg/m² in IV infusion over 30-40 minutes at Day 1, 8 and 15 followed by one week of rest.
Other Names:
  • GEMZAR
Drug: Paclitaxel
80 mg/m² in IV infusion over 60 minutes at Day 1, 8 and 15 followed by 1 week of rest.
Other Names:
  • TAXOL
Active Comparator: Control
Gemcitabine alone until progression
Drug: Gemcitabine
1000 mg/m² in IV infusion over 30-40 minutes at Day 1, 8 and 15 followed by one week of rest.
Other Names:
  • GEMZAR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: Until death (life expectancy around 12 months)
Time from the date of randomization to the date of death from any cause
Until death (life expectancy around 12 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UNICANCER

Investigators

  • Principal Investigator: Christelle de la FOUCHARDIERE, Dr, UNICANCER

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 23, 2019

Primary Completion (Actual)

April 26, 2022

Study Completion (Actual)

April 26, 2022

Study Registration Dates

First Submitted

May 7, 2019

First Submitted That Met QC Criteria

May 7, 2019

First Posted (Actual)

May 9, 2019

Study Record Updates

Last Update Posted (Actual)

January 15, 2026

Last Update Submitted That Met QC Criteria

January 13, 2026

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UC-0110/1809
  • 2018-002886-21 (EudraCT Number)
  • PRODIGE 65 - UCGI 36 (Other Identifier: UNICANCER)

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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