Clinical trial · Interventional
Efficacy and Tolerance Evaluation in FOLFIRINOX Dose Adjusted in Elderly Patients With a Metastatic Pancreatic Cancer
Phase-2 Study Evaluating Overall Response Rate (Efficacy) and Autonomy Daily Living Preservation (Tolerance) of "FOLFIRINOX " Pharmacogenetic Dose Adjusted, in Elderly Patients (70 yo. or Older) With a Metastatic Pancreatic Adenocarcinoma.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Metastatic pancreatic carcinomas represent the 5th cause of cancer death in France (#8000 per year). The median age at diagnosis is 69 and 74 in male and female respectively. When the 5-Fluorouracile has been used as a single agent with a limited efficacy during more than 20 years, the onset of gemcitabine in 1995 has led to a moderate increase of median survival (from 4.41 to 5.65 months) and overall survival at 1 year (2 versus 18%). Recently, in a phase II followed by a phase-III study, a French collaborative group has demonstrated the benefit of "FOLFIRINOX " regimen versus gemcitabine alone, in terms of median survival (11.1 versus 6.8 months), progression-free survival (6.4 versus 3.3 months) and response rate (31.6 versus 9.4%). Although more hematologic (neutropenia) and GI toxicities were observed, FOLFIRINOX was acceptable as a new standard regimen for the majority of patients under the age of 70 with a good Performans Status. To reduce the toxicity of FOLFIRINOX in elderly patients (\> 70 yo), pharmacogenetic monitoring of 5-FU and Irinotecan key metabolism enzymes (DPD and UGTA1) may be easily performed. The methodology of the study is to use the Bryant \& Day statistical method, allowing to consider simultaneously as principal objective, the response rate (efficacy) and the tolerance (preservation of autonomy daily living, Katz index): this design is particularly fitting in a study for elderly patients who represent half of the pancreatic carcinoma population.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Metastatic Cancer | — | UNRESOLVED | — |
| Toxicity | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-FU | Drug | Fluorouracil | ALIAS |
| Folinic acid | Drug | — | UNRESOLVED |
| Irinotecan | Drug | Irinotecan | ALIAS |
| Oxaliplatine | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- FOLFIRINOX
- description
- FOLFIRINOX (D1-D15, for maximum 12 cycles) = Oxaliplatine + Folinic acid + Irinotecan + 5-FU
- interventionNames
- Drug: Oxaliplatine
- Drug: Folinic acid
- Drug: Irinotecan
- Drug: 5-FU
Primary outcomes (1)
- measure
- Composite Safety and Early Efficacy Assessment in the First 34 Patients
- timeFrame
- From treatment initiation through Week 12
- description
- This outcome is a composite assessment combining safety and early efficacy signals in the first 34 enrolled patients. Safety is measured by the occurrence of grade ≥3 toxicities (NCI-CTCAE v4.0). Early efficacy is assessed by the presence or absence of tumor response according to predefined stopping rules. Both components contribute jointly to the decision-making criteria for continuation of the study. This description corresponds specifically to the data reported in the Results section.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven ductal pancreatic carcinoma * Metastatic disease * First-line treatment : No previous chemotherapy in metastatic stage but adjuvant treatment before relapse (secondary metastatic) is permitted, provide it has been administered more than 6 months before) * Age of 70 yo or above * Normal DPD enzyme level or partial defect (excluding total defect) * Adequate bone marrow reserve: as indicated by : neutrophils \>1500/mm3, platelets \>100,000/ mm3, Hb \>10.0g/dL. * Adequate Renal function as indicated by: MDRD creatinine clearance \> 50ml/min. * Adequate hepatic function as indicated by: serum bilirubin \< 1.5 times the upper limit of normal, AST and ALT \< 2.5 times the upper limit of normal, or \< 5 times the upper limit of normal if liver metastases are present. * Written informed consent must be obtained prior to protocol-specific procedures are being performed * Patient is affiliated to a social security category Exclusion Criteria: * Other than ductal pancreatic carcinoma: namely endocrin tumors, acinar cells carcinoma, cystadenocarcinoma or adenocarcinoma of the ampulla of vater * Non-metastatic but locally advanced pancreatic adenocarcinoma * Complete DPD deficiency * History of Cardiac failure or symptomatic coronary artery disease * Autonomy Daily Living score by Katz \<4 * Prior treatment with FOLFIRINOX (adjuvant) * Major comorbidity likely to be an obstacle to treatment * Active or uncontrolled infection such as HIV or chronic B or C hepatitis * Uncontrolled diabetes mellitus * Prior peripheral neuropathy, grade \> 2 * Inflammatory bowel disease localized on the colon or rectum; bowel obstruction or severe uncontrolled diarrhea * Previous or concomitant malignancies other than effectively treated carcinoma in situ of the cervix or non-melanoma skin cancer * Hereditary fructose intolerance * Persons deprived of liberty or under guardianship * Any social, geographical or psychological condition which would compromise the ability to fully comply with the trial procedures and treatments
References
Publications (0)
Data not yet available