SEQUENTIAL GEMCITABINE PLUS NABPACLITAXEL (GEMBRAX) TREATMENT FOLLOWED BY FOLFIRINOX or FOLFIRINOX IN PATIENTS TREATED FOR FIRST LINE METASTATIC PANCREATIC CANCER
- Conditions
- METASTATIC ADENOCARCINOMA OF PANCREATICMedDRA version: 21.0Level: LLTClassification code 10033599Term: Pancreatic adenocarcinoma metastaticSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2021-001353-31-FR
- Lead Sponsor
- Institut régional du Cancer de Montpellier
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 210
1. Male or female aged 18 to 75 on the date the consent is signed.
2. Histologically or cytologically proven metastatic pancreatic adenocarcinoma. The definitive diagnosis of pancreatic adenocarcinoma metastases will be made by integrating the histopathological data in the context of the radiological data.
3. One or more metastatic lesion (s) measurable (Recist 1.1) by Thoraco-Abdomino-Pelvic scanner (or hepatic MRI and Thoraco-Abdomino-Pelvic scanner not injected, if the patient is allergic to the product of contrast).
4. Previous treatment (including radiochemotherapy) for the non-metastatic disease authorized if a delay = 6 months between the last treatment and the recurrence is respected.
5. WHO performance status = 1.
6. Uracilemia <16 ng / ml
7. Acceptable hematological assessment at inclusion (obtained within 14 days before the start of treatment) defined by:
• Neutrophils = 2 × 109 / L;
• Platelets = 100,000 / mm3 (100 × 109 / L);
• Hemoglobin = 9 g / dl.
8. Acceptable renal and hepatic function at inclusion (obtained within 14 days before the start of treatment) defined by:
• AST and ALT = 2.5 x upper limit of the standard (ULN), unless liver metastases are present in this case AST and ALT = 5 × ULN is allowed;
• Total bilirubin = 1.5 x ULN;
• Serum creatinine within the limits of the norm or calculated clearance = 50ml / min for patients with a serum creatinine value above or below the values of the norm (clearance calculated by the CDK-EPI formula).
9. Calcemia AND magnesemia AND kalaemia = LIN and = 1.2 x ULN
10. If the patient is sexually active, he must agree to use contraception deemed adequate and appropriate by the investigator during the entire period of administration of the study drug. In addition, male and female patients should use contraception after completion of treatment, as recommended in the Summary of Product Characteristics or product prescribing information provided in the study manual.
11. Signature of consent prior to any procedure specific to the study.
12. Affiliated with the French health insurance plan.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 210
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 210
. Known brain metastasis.
2. Previous treatment with radiotherapy, surgery, chemotherapy or experimental therapy for the treatment of metastatic disease.
3. Major surgery, other than diagnostic surgery (that is, surgery done to obtain a diagnostic biopsy without organ harvesting), within 4 weeks of day 1 of study treatment.
4. Known Gilbert's syndrome or homozygous for validated UGT1A1 * 28
5. Other concomitant cancer or history of cancer, except cervical cancer in situ treated, skin basal or squamous cell carcinoma, superficial bladder tumor (Ta, Tis, and T1) or a tumor with a good prognosis treated curatively without chemotherapy and without any sign of disease in the 3 years preceding inclusion.
6. Patients with high cardiovascular risk, including, but not limited to, coronary stent or myocardial infarction within the past 6 months.
7. Peripheral sensory neuropathy = grade 2 at the time of inclusion.
8. ECG with a QTc interval greater than 450 ms for men and greater than 470 ms for women
9. History of chronic inflammatory disease of the colon or rectum
10. Any other concomitant and unbalanced disease or serious disturbance that may interfere with the patient's participation in the study and his safety during the study (eg severe hepatic, renal, pulmonary, metabolic, or psychiatric disorders)
11. Intolerance or allergy to one of the study drugs (gemcitabine, nab-paclitaxel, oxaliplatin, irinotecan, 5-FU) or to an excipient of one of the drugs (example: fructose) described in the sections Against SPC indications or Special Warnings and Precautions or Prescribing Information
12. Legal incapacity (patient under curatorship or under tutorship)
13. Pregnant or breastfeeding woman. If a patient is of childbearing age, she must have a negative pregnancy test (ß-hCG serum) documented 72 hours before inclusion
14. Patients using AVK (Coumadin ...) (possible modification of treatment before inclusion)
15. Active and uncontrolled bacterial or viral or fungal infection requiring systemic treatment.
16. History or known HIV infection.
17. History of peripheral arterial disease (eg, claudication, Leo Buerger's disease).
18. Patient who received a live attenuated vaccine within 10 days before inclusion
19. Patients with a history of pulmonary fibrosis or interstitial pneumonia.
20. The patient refuses or is unable to comply with study procedures.
21. Inability to undergo medical monitoring of the trial for geographical, social or psychological reasons.
22. Participation in another clinical study with an investigational product within the last 30 days prior to inclusion
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method