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219 countries
Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.

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

Clinicaltrials.gov identifier NCT03943667

Recruitment Status Recruiting

First Posted May 9, 2019

Last update posted August 25, 2020

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


Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 210 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: May 2022
  • Estimated Study Completion Date: December 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

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

- 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

- 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

Contact: Nicolas LACHAUX +33 1 71 93 61 60 n-lachaux@unicancer.fr

Contact: Nicolas de SOUSA CARVALHO +33 1 71 93 67 09 n-de-sousa@unicancer.fr

Show 28 Study Locations
Sponsors and Collaborators



Principal Investigator: Christelle de la FOUCHARDIERE, Dr UNICANCER

More Information