Clinical trial NCT03943667: Gemcitabine and Paclitaxel vs Gemcitabine Alone After FOLFIRINOX Failure in Metastatic Pancreatic Ductal Adenocarcinoma
Official title: A Phase III Randomized Study Evaluating Gemcitabine and Paclitaxel Versus Gemcitabine Alone After FOLFIRINOX Failure or Intolerance in Metastatic Pancreatic Ductal Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Metastatic Pancreatic Adenocarcinoma
Keywords: Metastatic Pancreas Ductal Adenocarcinoma
Lead sponsor: UNICANCER
Sponsor class: OTHER
First posted: 2019-05-09
Enrollment: 211
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Overall Survival
timeFrame: Until death (life expectancy around 12 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Bayeux
country: France
facility: CH de Bayeux
city: Beauvais
country: France
facility: CH Simone Veil
city: Besançon
country: France
facility: CHU Jean Minjoz
city: Boulogne-sur-Mer
country: France
facility: Hôpital Duchenne
city: Cherbourg
country: France
facility: CH du Cotentin
city: Dijon
country: France
facility: Centre Georges François Leclerc
city: Lyon
country: France
facility: Centre Léon Bérard
city: Lyon
country: France
facility: Hospices civils de Lyon
city: Marseille
country: France
facility: CHU La Timone
city: Marseille
country: France
facility: Hôpital Européen de Marseille
city: Marseille
country: France
facility: Hôpital Saint-Joseph
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: Montbéliard
country: France
facility: Hôpital Nord Franche Comté
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Paris
country: France
facility: Hôpital Saint-Louis
city: Paris
country: France
facility: Institut Mutualiste Montsouris
city: Paris
country: France
facility: Hôpital Pitié-Salpétrière
city: Reims
country: France
facility: Institut Godinot
city: Rennes
country: France
facility: Centre Eugène Marquis
city: Rouen
country: France
facility: CHU Rouen
city: Saint-Cloud
country: France
facility: Institut Curie
city: Saint-Herblain
country: France
facility: Institut de Cancérologie de l'Ouest
city: Saint-Malo
country: France
facility: Hôpital Broussais
city: Saint-Étienne
country: France
facility: CHU de Saint-Etienne
city: Tours
country: France
facility: Hôpital Trousseau
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: UNICANCER
name: Christelle de la FOUCHARDIERE, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.