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Trial record 1 of 1 for:    gempax | France
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Gemcitabine and Paclitaxel vs Gemcitabine Alone After FOLFIRINOX Failure in Metastatic Pancreatic Ductal Adenocarcinoma (GEMPAX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03943667
Recruitment Status : Suspended (Temporary suspension since March 20th, 2020 due to COVID-19 pandemic)
First Posted : May 9, 2019
Last Update Posted : April 28, 2020
Sponsor:
Information provided by (Responsible Party):
UNICANCER

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
Metastatic Pancreatic Adenocarcinoma Drug: Gemcitabine Drug: Paclitaxel Phase 3

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Study Type : Interventional  (Clinical Trial)
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 23, 2019
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: GEMZAR




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



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03943667


Locations
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Sponsors and Collaborators
UNICANCER
Investigators
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Principal Investigator: Christelle de la FOUCHARDIERE, Dr UNICANCER
Publications:
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Responsible Party: UNICANCER
ClinicalTrials.gov Identifier: NCT03943667    
Other Study ID Numbers: UC-0110/1809
2018-002886-21 ( EudraCT Number )
PRODIGE 65 - UCGI 36 ( Other Identifier: UNICANCER )
First Posted: May 9, 2019    Key Record Dates
Last Update Posted: April 28, 2020
Last Verified: April 2020

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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:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gemcitabine
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs