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

Metastatic Pancreatic Adenocarcinoma Clinical Trial

— GEMPAX  

Official title:

A Phase III Randomized Study Evaluating Gemcitabine and Paclitaxel Versus Gemcitabine Alone After FOLFIRINOX Failure or Intolerance in Metastatic Pancreatic Ductal Adenocarcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03943667
• Other study ID #: UC-0110/1809
• Secondary ID: 2018-002886-21PR
• Status: Completed
• Phase: Phase 3
• Start date: May 23, 2019
• Est. completion date: April 26, 2022

Study information

• Verified date: November 2023
• Source: UNICANCER
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 211
• Est. completion date: April 26, 2022
• Est. primary completion date: April 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Metastatic Pancreatic Adenocarcinoma

Intervention

Drug:
• Gemcitabine
1000 mg/m² in IV infusion over 30-40 minutes at Day 1, 8 and 15 followed by one week of rest.
• Paclitaxel
80 mg/m² in IV infusion over 60 minutes at Day 1, 8 and 15 followed by 1 week of rest.

Locations

Country	Name	City	State
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 Pitié-Salpétrière	Paris
France	Hôpital Saint-Louis	Paris
France	Institut Mutualiste Montsouris	Paris
France	Institut Godinot	Reims
France	Centre Eugène Marquis	Rennes
France	CHU Rouen	Rouen
France	Institut Curie	Saint-Cloud
France	CHU de Saint-Etienne	Saint-Étienne
France	Institut de Cancérologie de l'Ouest	Saint-Herblain
France	Hôpital Broussais	Saint-Malo
France	Hôpital Trousseau	Tours
France	Institut Gustave Roussy	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
UNICANCER

Country where clinical trial is conducted

France, 

References & Publications (1)

Conroy T, Desseigne F, Ychou M, Bouche O, Guimbaud R, Becouarn Y, Adenis A, Raoul JL, Gourgou-Bourgade S, de la Fouchardiere C, Bennouna J, Bachet JB, Khemissa-Akouz F, Pere-Verge 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival	Time from the date of randomization to the date of death from any cause	Until death (life expectancy around 12 months)