NCT03943667

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
211

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2019

Typical duration for phase_3

Geographic Reach
1 country

26 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 9, 2019

Completed
14 days until next milestone

Study Start

First participant enrolled

May 23, 2019

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2022

Completed
3.7 years until next milestone

Results Posted

Study results publicly available

January 15, 2026

Completed
Last Updated

January 15, 2026

Status Verified

September 1, 2025

Enrollment Period

2.9 years

First QC Date

May 7, 2019

Results QC Date

April 22, 2025

Last Update Submit

January 13, 2026

Conditions

Metastatic Pancreatic Adenocarcinoma

Keywords

Metastatic Pancreas Ductal Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

  • Overall Survival

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

    Until death (life expectancy around 12 months)

Study Arms (2)

GEMPAX

EXPERIMENTAL

Gemcitabine + Paclitaxel until progression

Drug: GemcitabineDrug: Paclitaxel

Control

ACTIVE COMPARATOR

Gemcitabine alone until progression

Drug: Gemcitabine

Interventions

GemcitabineDRUG

1000 mg/m² in IV infusion over 30-40 minutes at Day 1, 8 and 15 followed by one week of rest.

Also known as: GEMZAR
ControlGEMPAX
PaclitaxelDRUG

80 mg/m² in IV infusion over 60 minutes at Day 1, 8 and 15 followed by 1 week of rest.

Also known as: TAXOL
GEMPAX

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

CH de Bayeux

Bayeux, France

Location

CH Simone Veil

Beauvais, France

Location

CHU Jean Minjoz

Besançon, France

Location

Hôpital Duchenne

Boulogne-sur-Mer, France

Location

CH du Cotentin

Cherbourg, France

Location

Centre Georges François Leclerc

Dijon, France

Location

Centre Léon Bérard

Lyon, France

Location

Hospices civils de Lyon

Lyon, France

Location

CHU La Timone

Marseille, France

Location

Hôpital Européen de Marseille

Marseille, France

Location

Hôpital Saint-Joseph

Marseille, France

Location

Institut Paoli Calmettes

Marseille, France

Location

Hôpital Nord Franche Comté

Montbéliard, France

Location

Centre Antoine Lacassagne

Nice, France

Location

Hôpital Saint-Louis

Paris, 75011, France

Location

Institut Mutualiste Montsouris

Paris, 75014, France

Location

Hôpital Pitié-Salpétrière

Paris, France

Location

Institut Godinot

Reims, France

Location

Centre Eugène Marquis

Rennes, France

Location

CHU Rouen

Rouen, France

Location

Institut Curie

Saint-Cloud, France

Location

CHU de Saint-Etienne

Saint-Etienne, France

Location

Institut de Cancérologie de l'Ouest

Saint-Herblain, France

Location

Hôpital Broussais

St-Malo, France

Location

Hôpital Trousseau

Tours, France

Location

Institut Gustave Roussy

Villejuif, France

Location

Related Publications (2)

  • 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.

    PMID: 21561347BACKGROUND

  • De La Fouchardiere C, Malka D, Cropet C, Chabaud S, Raimbourg J, Botsen D, Launay S, Evesque L, Vienot A, Perrier H, Jary M, Rinaldi Y, Coutzac C, Bachet JB, Neuzillet C, Williet N, Desgrippes R, Grainville T, Aparicio T, Peytier A, Lecomte T, Roth GS, Thirot-Bidault A, Lachaux N, Bouche O, Ghiringhelli F. Gemcitabine and Paclitaxel Versus Gemcitabine Alone After 5-Fluorouracil, Oxaliplatin, and Irinotecan in Metastatic Pancreatic Adenocarcinoma: A Randomized Phase III PRODIGE 65-UCGI 36-GEMPAX UNICANCER Study. J Clin Oncol. 2024 Mar 20;42(9):1055-1066. doi: 10.1200/JCO.23.00795. Epub 2024 Jan 17.

    PMID: 38232341DERIVED

MeSH Terms

Interventions

GemcitabinePaclitaxel

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Results Point of Contact

Title
Dr Christelle DE LA FOUCHARDIERE
Organization
Institut Paoli Calmettes
DELAFOUCHARDIEREC@ipc.unicancer.fr
+33(0)491223333

Study Officials

  • Christelle de la FOUCHARDIERE, Dr

    UNICANCER

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2019

First Posted

May 9, 2019

Study Start

May 23, 2019

Primary Completion

April 26, 2022

Study Completion

April 26, 2022

Last Updated

January 15, 2026

Results First Posted

January 15, 2026

Record last verified: 2025-09

Locations

FR(26)