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

Sponsor
UNICANCER (Other)
Overall Status
Completed
CT.gov ID
NCT03943667
Collaborator
(none)
211
Enrollment
26
Locations
2
Arms
35.1
Actual Duration (Months)
8.1
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
211 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase III Randomized Study Evaluating Gemcitabine and Paclitaxel Versus Gemcitabine Alone After FOLFIRINOX Failure or Intolerance in Metastatic Pancreatic Ductal Adenocarcinoma
Actual Study Start Date :
May 23, 2019
Actual Primary Completion Date :
Apr 26, 2022
Actual Study Completion Date :
Apr 26, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Overall Survival [Until death (life expectancy around 12 months)]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CH de Bayeux Bayeux France
    2 CH Simone Veil Beauvais France
    3 CHU Jean Minjoz Besançon France
    4 Hôpital Duchenne Boulogne-sur-Mer France
    5 CH du Cotentin Cherbourg France
    6 Centre Georges François Leclerc Dijon France
    7 Centre Léon Bérard Lyon France
    8 Hospices civils de Lyon Lyon France
    9 CHU La Timone Marseille France
    10 Hôpital Européen de Marseille Marseille France
    11 Hôpital Saint-Joseph Marseille France
    12 Institut Paoli Calmettes Marseille France
    13 Hôpital Nord Franche Comté Montbéliard France
    14 Centre Antoine Lacassagne Nice France
    15 Hôpital Saint-Louis Paris France 75011
    16 Institut Mutualiste Montsouris Paris France 75014
    17 Hôpital Pitié-Salpétrière Paris France
    18 Institut Godinot Reims France
    19 Centre Eugène Marquis Rennes France
    20 CHU Rouen Rouen France
    21 Institut Curie Saint-Cloud France
    22 Institut de Cancérologie de l'Ouest Saint-Herblain France
    23 Hôpital Broussais Saint-Malo France
    24 CHU de Saint-Etienne Saint-Étienne France
    25 Hôpital Trousseau Tours France
    26 Institut Gustave Roussy Villejuif France

    Sponsors and Collaborators

    • UNICANCER

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    UNICANCER
    ClinicalTrials.gov Identifier:
    NCT03943667
    Other Study ID Numbers:
    • UC-0110/1809
    • 2018-002886-21
    • PRODIGE 65 - UCGI 36
    First Posted:
    May 9, 2019
    Last Update Posted:
    May 18, 2022
    Last Verified:
    May 1, 2022
    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
    Keywords provided by UNICANCER
    Metastatic Pancreas Ductal Adenocarcinoma
    Additional relevant MeSH terms:
    Adenocarcinoma
    Gemcitabine
    Paclitaxel

    Study Results

    No Results Posted as of May 18, 2022