Phase I-II trial of gemcitabine plus nab-paclitaxel (GemBrax) followed by FOLFIRINOX as first-line treatment of patients with metastatic pancreatic adenocarcinoma - GABRINOX

Institut Régional de Cancerologie de Montpellier - Val d’Aurelle0 sites118 target enrollmentJuly 31, 2013

Overview

No summary available.

Registry

who.int

Start Date

July 31, 2013

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Institut Régional de Cancerologie de Montpellier - Val d’Aurelle

•1\.Histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas. The definitive diagnosis of metastatic pancreatic adenocarcinoma will be made by integrating the histopathological data within the context of the radiologic data.
•2\.Initial diagnosis of metastatic disease must have occurred \=6 weeks prior to inclusion in the study.
•3\.One or more measurable metastatic lesions (Recist 1\.1\) by CT scan of the abdomen, pelvis and chest, or hepatic MRI and CT scan (abdomen, pelvis and chest) without injection, if patient is allergic to CT contrast media).
•4\.No previous radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of metastatic disease.
•5\.Prior treatment with 5 FU or gemcitabine administered as a radiation sensitizer in the adjuvant setting is allowed, provided that at least 6 months have relapsed since completion of the last dose and no lingering toxicities are present.
•6\.Eastern Cooperative Oncology Group (ECOG) performance status of \= 1\.
•7\.Males or females aged 18 to 75 years at the time of signing the Informed Consent Form (ICF).
•8\.Adequate blood function at baseline (obtained within 14 days before start of study treatment) as defined by :
•Absolute neutrophil count (ANC) \= 1\.5 × 10^9/L;
•Platelets count \= 100,000/mm3 (100 × 10^9/L);

•1\.Known brain metastases.
•2\.Patient has only locally advanced disease.
•3\.History of other malignancy in the last 5 years. Patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible. Patients with other malignancies are eligible if they were cured by surgery alone or surgery plus radiotherapy and have been continuously disease\-free for at least 5 years.
•4\.Patients having received cytotoxic doses of any other chemotherapy (than 5FU and gemcitabine) in the adjuvant setting.
•5\.Peripheral sensory neuropathy \= grade 2 at the time of signing the ICF.
•6\.Patients using AVKs (Coumadin…)
•7\.Active and uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
•8\.Known historical or active infection with HIV
•9\.Major surgery, other than diagnostic surgery (i.e. surgery done to obtain a biopsy for diagnosis without removal of an organ), within 4 weeks prior to Day 1 of treatment in this study.
•10\.History of allergy or hypersensitivity to any of the study drugs or any of their excipients, or the patient exhibits any of the events outlined in the Contraindications or Special Warnings and Precautions sections of the SmPCs or Prescribing Information.