None listed
Conditions
Interventions
Product Name: Oxaliplatin
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: OXALIPLATIN
CAS Number: 61825-94-3
Concentrati
Sponsors
Assistance Publique- Hôpitaux de Paris
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed and dated informed consent, and willing and able to comply with protocol requirements, 2. Histologically or cytologically proven adenocarcinoma of the pancreas, 3. In absence of histologically or cytologically proven adenocarcinoma, a cluster of clinical, biological and radiological arguments consistent with the diagnosis: among these, a hypodense pancreatic tumor at CT and a Ca 19-9 greater than 500 UI/ml are essential prerequisites, 4. Metastatic disease confirmed (stage IV), 5. No prior therapy for metastatic disease (in case of previous adjuvant therapy, interval from end of chemotherapy and relapse must be >12 months), 6. Age =18 years, 7. Patient non-fit for FOLFIRINOX, with ECOG performance status (PS) 0-2 8. For patients with ECOG performance status (PS) = 2, an albuminemia level >25 g/l is required. An albumin infusion is not permitted before the inclusion test, 9. Haematological status: neutrophils (ANC) >1.5x109/L; platelets >100x109/L; haemoglobin =9g/dL, 10. Adequate renal function: serum creatinine level =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. History or evidence upon physical examination of CNS metastasis unless adequately treated (e.g. non irradiated CNS metastasis, seizure not controlled with standard medical therapy), 2. Local or locally advanced disease (stage I to III), 3. Patient uses warfarin, 4. Patient receiving concomitant radiotherapy, 5. Uncontrolled hypercalcemia, 6. Pre-existing permanent neuropathy (NCI grade =2), 7. Poor nutritional status 8. Known dihydropyrimidine dehydrogenase (DPD) deficiency, 9. Concomitant unplanned antitumor therapy (e.g. chemotherapy, molecular targeted therapy, immunotherapy), 10. Treatment with any other investigational medicinal product within 28 days prior to study entry, 11. Other serious and uncontrolled non-malignant disease (eg. active infection requiring systemic therapy, coronary stenting or myocardial infarction or stroke in the past 6 months), 12. Known or historical active infection with HIV, or known active infection untreated with hepatitis B or hepatitis C, 13. Known uncontrolled bacterial infection 14. History or active interstitial lung disease (ILD), 15. Other concomitant or previous malignancy, except: i/ adequately treated in-situ carcinoma of the uterine cervix, ii/ basal or squamous cell carcinoma of the skin, iii/ cancer in complete remission for >5 years, 16. Patients with known allergy to active substance or any excipient of study drugs, 17. Allergy to iodinated contrast product 18. Concomitant administration of live, attenuated virus vaccine such as yellow fever vaccine and concomitant administration of prophylactic phenytoin 19. Patients under legal protection or unable to consent 20. Participation in another interventional research
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of FOLFOX in comparison to gemcitabine in metastatic first-line in patients with pancreatic adenocarcinoma and non-fit for FOLFIRINOX. ;Primary end point(s): Overall survival (OS) at 24 months; Secondary Objective: he others efficacy parameters centered on the tumor: objective response rate and disease control rate (RECIST v1.1, in case of evaluable lesion), duration of response, duration of disease control - The progression free survival (PFS) - The evolution of biomarkers Ca 19-9 and CEA to assess their prognostic value at inclusion and their predictive value under treatment - The toxicities according to International Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. - The safety of both arms - The quality of life - The dose intensity (DI) of each protocol - The Quality-Adjusted Survival - The rate and type of second-line / third-line regimens chemotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Objective response rate and disease control rate (RECIST criteria 1.1), duration of response, duration of disease control. - Progression-free survival (PFS) will be defined as the delay between the date of inclusion and the date of the first event (progression or death) or date of last news if the patient is alive without any progression. - Ca 19-9 and CEA levels, at inclusion and their dynamic change under treatment. - Toxicities will be described by type of toxicities and grades according to International Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. - Safety: rate of serious adverse events, grade 3-4 toxicities (hematologic and non-hematologic). Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0. - Quality of life will be studied by means of the EORTC QLQ C-30 questionnaire, the health-related quality of life (HRQoL) and the consensual geriatric minimum data set (SOFOG) for patients =75 years and - The dose-intensity (DI) of each protocol will be calculated based on the number of cycles received by each patient. The relative DI will be calculated as the ratio of the DI to the DI indicated in the protocol (obtained as the dose specified per cycle in mg/m²). - The Quality-adjusted Time WIthout Symptoms of disease or Toxicity (Q-TWIST) - Type of second-line and third-line regimens and the date of beginning of first-cycle of each line will be collected. | — |
Countries
France
Contacts
Public ContactFatiha Djennaoui
Assistance Publique-Hôpitaux de Paris
Outcome results
None listed