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出境医 / 临床实验 / Gemcitabine and Paclitaxel vs Gemcitabine Alone After FOLFIRINOX Failure in Metastatic Pancreatic Ductal Adenocarcinoma (GEMPAX)

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

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
Metastatic Pancreatic Adenocarcinoma Drug: Gemcitabine Drug: Paclitaxel Phase 3

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
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
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : October 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 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
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
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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
Contacts and Locations

Locations
Show Show 26 study locations
Sponsors and Collaborators
UNICANCER
Investigators
Layout table for investigator information
Principal Investigator: Christelle de la FOUCHARDIERE, Dr UNICANCER
Tracking Information
First Submitted Date  ICMJE May 7, 2019
First Posted Date  ICMJE May 9, 2019
Last Update Posted Date April 5, 2021
Actual Study Start Date  ICMJE May 23, 2019
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 7, 2019) 		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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Gemcitabine and Paclitaxel vs Gemcitabine Alone After FOLFIRINOX Failure in Metastatic Pancreatic Ductal Adenocarcinoma
Official Title  ICMJE A Phase III Randomized Study Evaluating Gemcitabine and Paclitaxel Versus Gemcitabine Alone After FOLFIRINOX Failure or Intolerance in Metastatic Pancreatic Ductal Adenocarcinoma
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Pancreatic Adenocarcinoma
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: GEMPAX
    Gemcitabine + Paclitaxel until progression
    Interventions:
    • Drug: Gemcitabine
    • Drug: Paclitaxel
  • Active Comparator: Control
    Gemcitabine alone until progression
    Intervention: Drug: Gemcitabine
Publications * Conroy T, Desseigne F, Ychou M, Bouché O, Guimbaud R, Bécouarn Y, Adenis A, Raoul JL, Gourgou-Bourgade S, de la Fouchardière C, Bennouna J, Bachet JB, Khemissa-Akouz F, Péré-Vergé 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 2, 2021) 		211
Original Estimated Enrollment  ICMJE
 (submitted: May 7, 2019) 		210
Estimated Study Completion Date  ICMJE October 2022
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03943667
Other Study ID Numbers  ICMJE UC-0110/1809
2018-002886-21 ( EudraCT Number )
PRODIGE 65 - UCGI 36 ( Other Identifier: UNICANCER )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party UNICANCER
Study Sponsor  ICMJE UNICANCER
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christelle de la FOUCHARDIERE, Dr UNICANCER
PRS Account UNICANCER
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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