Clinical trial · Interventional
FIrst Line Treatment of Metastatic Pancreatic Cancer: Sequential Nab-paclitaxel + Gemcitabine/FOLFIRI.3 VS Nab-paclitaxel + Gemcitabine
Phase II Randomised Multicenter Trial Evaluating a Sequential Treatment With Nab-paclitaxel+Gemcitabine /FOLFIRI.3 vs Nab-paclitaxel + Gemcitabine in First Line Metastatic Pancreatic Cancer
NCT02827201CI-TRIAL-00078651FIRGEMAXcompletedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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)
The main objective of this trial is to evaluate every 2 months alternating nab-paclitaxel/gemcitabine and FOLFIRI.3 versus nab-paclitaxel + gemcitabine, regarding the progression of disease at 6 months.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FOLFIRI.3 | Drug | FOLFIRI Regimen | ALIAS |
| nab-paclitaxel+ gemcitabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- nab-paclitaxel + gemcitabine/FOLFIRI.3
- description
- Alternance of : * 2 months with nab-paclitaxel (125 g/m² - 30 min in IV) + gemcitabine (1000 mg/m², 30 min in IV, 3 injections follow by 1 week free) * follow by 2 months with FOLFIRI.3 (irinotecan: 90 mg/m² at D1, acid folinic 400 mg/m², 5Fu continus: 2000 mg/m² IV 46 hours, and irinotecan at D3, 90 mg/m²) This alternance continus until progression
- interventionNames
- Drug: FOLFIRI.3
- Drug: nab-paclitaxel+ gemcitabine
- type
- ACTIVE_COMPARATOR
- label
- nab-paclitaxel + gemcitabine
- description
- nab-paclitaxel (125 g/m² - 30 min in IV) + gemcitabine (1000 mg/m² - 30 min in IV) 3 injections follow by 1 week free, until progression
- interventionNames
- Drug: nab-paclitaxel+ gemcitabine
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histological or cytological confirmation of pancreatic adenocarcinoma * Distant metastatic disease * Scan (or MRI if scanner contraindicated) completed within 3 weeks of the start of treatment * At least one lesion measurable by RECIST v1.1 criteria * Life expectancy\> 3 months * No previous chemotherapy (adjuvant chemotherapy with gemcitabine authorised if administered more than 6 months prior to inclusion) * No previous radiotherapy (unless at least one measurable target lesion outside the irradiation zone) * Pain must be monitored before inclusion * 18 years \< age \< 75 * Performance status: WHO \< 2 * ANC ≥ 1500/mm3, platelets ≥ 100 000/mm3, haemoglobin ≥ 9 g/dL * ASAT (SGOT), ALAT (SGPT) ≤ 2.5 x ULN or ≤ 5 x ULN if liver metastases found * Bilirubin ≤ 1.5 x ULN (patients drained by retrograde technique are includable), creatinine \< 120 μmol/L, or MDRD creatinine clearance \> 60 mL/min * Women of childbearing age must have a negative pregnancy test (β HCG) before starting treatment * Women of childbearing age as well as men (who have sexual intercourse with women of childbearing age) must agree to use effective contraception without interruption for the duration of treatment and 6 months after the administration of the last treatment dose * Patient affiliated to the social security scheme * Patient information and signature of informed consent Exclusion Criteria: * \- Other types of pancreatic tumours, especially endocrine or acinar cell tumours * Ampulloma * Presence of meningeal or cerebral metastases, bone metastases * Gilbert's syndrome * Presence of neuropathy\> grade 1 according to NCIC-CTC 4.0 * Contraindications specific to the studied treatments * History of chronic diarrhoea or inflammatory disease of the colon or rectum, or of unresolved occlusion or sub-occlusion for which symptomatic treatment is being administered * Other concomitant cancer or history of cancer during the 5 years, with the exception of a carcinoma in situ of the cervix or basal cell or squamous cell carcinoma, considered cured * Significant history of heart or respiratory disease, including any history of interstitial pneumonia * Patient already included in another clinical trial with an experimental molecule * Women who are breast-feeding * Persons deprived of liberty or under guardianship * Unable to submit to medical monitoring during the trial due to geographical, social or psychological reasons
References
Publications (1)
- RESULTRinaldi Y, Pointet AL, Khemissa Akouz F, Le Malicot K, Wahiba B, Louafi S, Gratet A, Miglianico L, Laharie H, Bouhier Leporrier K, Thirot Bidault A, Texereau P, Coriat R, Terrebonne E, Gouttebel MC, Malka D, Bachet JB, Lepage C, Taieb J; PRODIGE 37 Investigators/Collaborators. Gemcitabine plus nab-paclitaxel until progression or alternating with FOLFIRI.3, as first-line treatment for patients with metastatic pancreatic adenocarcinoma: The Federation Francophone de Cancerologie Digestive-PRODIGE 37 randomised phase II study (FIRGEMAX). Eur J Cancer. 2020 Sep;136:25-34. doi: 10.1016/j.ejca.2020.05.018. Epub 2020 Jul 2. PMID 32623182