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

Phase 3

Completed

• Conditions: Metastatic Pancreatic Adenocarcinoma
• Interventions: Drug: Gemcitabine; Drug: Paclitaxel

• Registration Number: NCT03943667
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-07
• Study First Submitted QC: 2019-05-07
• Study First Posted: 2019-05-09
• Study Start: 2019-05-23
• Primary Completion: 2022-04-26
• Study Completion: 2022-04-26
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-07
• Last Update Posted: 2023-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 211

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Gemcitabine	Gemcitabine alone until progression
GEMPAX	Gemcitabine	Gemcitabine + Paclitaxel until progression
GEMPAX	Paclitaxel	Gemcitabine + Paclitaxel until progression

Primary Outcome Measures

Name	Time	Method
Overall Survival	Until death (life expectancy around 12 months)	Time from the date of randomization to the date of death from any cause

Trial Locations

Locations (26)

Hôpital Européen de Marseille; 🇫🇷 Marseille, France

Hôpital Pitié-Salpétrière; 🇫🇷 Paris, France

Hospices civils de Lyon; 🇫🇷 Lyon, France

CH de Bayeux; 🇫🇷 Bayeux, France

CHU Jean Minjoz; 🇫🇷 Besançon, France

CH Simone Veil; 🇫🇷 Beauvais, France

Hôpital Duchenne; 🇫🇷 Boulogne-sur-Mer, France

CH du Cotentin; 🇫🇷 Cherbourg, France

Centre Léon Bérard; 🇫🇷 Lyon, France

Centre Georges François Leclerc; 🇫🇷 Dijon, France

CHU La Timone; 🇫🇷 Marseille, France

Hôpital Saint-Joseph; 🇫🇷 Marseille, France

Institut Godinot; 🇫🇷 Reims, France

Institut Mutualiste Montsouris; 🇫🇷 Paris, France

Hôpital Nord Franche Comté; 🇫🇷 Montbéliard, France

Hôpital Saint-Louis; 🇫🇷 Paris, France

Institut Paoli Calmettes; 🇫🇷 Marseille, France

CHU Rouen; 🇫🇷 Rouen, France

Centre Antoine Lacassagne; 🇫🇷 Nice, France

Centre Eugène Marquis; 🇫🇷 Rennes, 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

Institut Gustave Roussy; 🇫🇷 Villejuif, France

Hôpital Trousseau; 🇫🇷 Tours, France