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At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

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

  • Clinicaltrials.gov identifier

    NCT03943667

  • Recruitment Status

    Active, not recruiting

  • First Posted

    May 9, 2019

  • Last update posted

    April 5, 2021

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:Metastatic Pancreatic Adenocarcinoma
  • Intervention/Treatment: Drug: Gemcitabine
    Drug: Paclitaxel
  • Phase: Phase 3

Detailed Description

N/A

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 2019
  • Estimated Primary Completion Date: March 2022
  • Estimated Study Completion Date: October 2022

Arms and interventions

Arm Intervention/treatment
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.
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.

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

Outcome Measures

  • Primary Outcome Measures: 1. 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

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Locations

France
CH de Bayeux
Bayeux

France
CH Simone Veil
Beauvais

France
CHU Jean Minjoz
Besançon

France
Hôpital Duchenne
Boulogne-sur-Mer

France
CH du Cotentin
Cherbourg

France
Centre Georges François Leclerc
Dijon

France
Centre Léon Bérard
Lyon

France
Hospices civils de Lyon
Lyon

France
CHU La Timone
Marseille

France
Hôpital Européen de Marseille
Marseille

France
Hôpital Saint-Joseph
Marseille

France
Institut Paoli Calmettes
Marseille

France
Hôpital Nord Franche Comté
Montbéliard

France
Centre Antoine Lacassagne
Nice

France
Hôpital Saint-Louis
Paris

France
Institut Mutualiste Montsouris
Paris

France
Hôpital Pitié-Salpétrière
Paris

France
Institut Godinot
Reims

France
Centre Eugène Marquis
Rennes

France
CHU Rouen
Rouen

France
Institut Curie
Saint-Cloud

France
Institut de Cancérologie de l'Ouest
Saint-Herblain

France
Hôpital Broussais
Saint-Malo

France
CHU de Saint-Etienne
Saint-Étienne

France
Hôpital Trousseau
Tours

France
Institut Gustave Roussy
Villejuif

Sponsors and Collaborators

UNICANCER

Investigators

Principal Investigator: Christelle de la FOUCHARDIERE, Dr UNICANCER