Clinical trial · Interventional
Second Line Chemotherapy for Advanced Pancreatic Cancer
Folfiri as Second-Line Chemotherapy for Advanced Pancreatic Cancer. A GISCAD Phase II Study
NCT01543412CI-TRIAL-00006372SLAPcompletedPhase 2ClinicalTrials.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)
No validated second-line chemotherapy for the treatment of locally advanced/metastatic pancreatic cancer is actually available,after the failure of a gemcitabine(+/- Cisplatin or Oxaliplatin)-based regimen. Irinotecan seems to be a moderately active drug in the treatment of this disease Recently was reported some interesting results using a potentially non -cross resistant regimen (FOLFIRI) which could be useful even as second-line chemotherapy. An exploratory study in this setting seem warranted.
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 |
|---|---|---|---|
| Pancreatic Adenocarcinoma | Pancreatic Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FOLFIRI | Drug | FOLFIRI Regimen | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- FOLFIRI
- description
- Folfiri consist of Irinotecan 180 mg/m2 iv on day 1, Leucovorin(l-form) 200 mg/m2 iv on day 1and 2, 5-FU 400 mg/m2 iv bolus on day 1and 2, 5-FU 600 mg/m2 iv by ci for 22 hours on day 1 and 2, repeated every 2 wks The use of antiemetic prophylaxis was decided locally.
- interventionNames
- Drug: FOLFIRI
Primary outcomes (1)
- measure
- Overall Response Rate (RECIST Criteria)
- timeFrame
- 2 years
- description
- time from randomization date to date of death from any cause
Secondary outcomes (3)
- measure
- Safety and tolerability; Safety (CTC criteria - version 3.0)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Signed written informed consent prior to beginning protocol specific procedures * Previous chemotherapy with Gemcitabine plus or less Platinoids * Previous gemcitabine delivered as a radiosensitizer for locally advanced disease, followed or not by a gemcitabine plus or less platinoids as maintenance or disease progression is allowed. * Male or female less than 75 years of age * Diagnosis of histologically or cytologically confirmed adenocarcinoma of the pancreas * Locally advanced (non-resectable) or metastatic pancreatic cancer * Presence of at least one uni-dimensional indicator lesion measurable by CT scan or MRI in not an irradiated area * ECOG performance status 0 to 1 at study entry * Life expectancy: more than 3 months * Neutrophils more than 1.5 x 109L, platelets more than 100 x 109L, and hemoglobin more than 10 gdL * Bilirubin level either normal or less than 1.5 x ULN * ASAT and ALAT normal or less than 2.5 x ULN (normal or less than 5 x ULN if liver metastasis are present) * Serum creatinine less than 1.5 x ULN * Amylase normal or less than 1.5 ULN * Effective contraception for both male and female patients if the risk of conception exists * Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed with the patient before registration in the trial Exclusion Criteria: * Brain metastases * Previous treatment with irinotecan or fluoropyrimidines * Significant cardiovascular disease: clinically relevant coronary artery disease or a history of a myocardial infarction within the last 6 months * Significant gastrointestinal abnormalities * Gilbert's Syndrome * Any uncontrolled infections * Known HIV infection * Radiotherapy within 4 weeks prior to study entry * Any investigational agents 4 weeks prior to entry * Known grade 3 or 4 allergic reaction to any of the components of the treatment * Known drug abuse or alcohol abuse * Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent * Women who are pregnant or breastfeeding * Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix. * Legal incapacity or limited legal capacity
References
Publications (1)
- DERIVEDZaniboni A, Aitini E, Barni S, Ferrari D, Cascinu S, Catalano V, Valmadre G, Ferrara D, Veltri E, Codignola C, Labianca R. FOLFIRI as second-line chemotherapy for advanced pancreatic cancer: a GISCAD multicenter phase II study. Cancer Chemother Pharmacol. 2012 Jun;69(6):1641-5. doi: 10.1007/s00280-012-1875-1. Epub 2012 May 11. PMID 22576338