Essai de phase II : Folfiri.3 (CPT-11/acide folinique/5-FU) / gemzar en traitement sequentiel des cancers du pancréas métastatiques non pré-traités - firgem

• Conditions: The trial will evaluate a sequential chemotherapy in patient suffering from metastatic pancreatic carcinoma which had not been treated in the past.; MedDRA version: 8.1Level: LLTClassification code 10033610Term: Pancreatic carcinoma metastatic

• Registration Number: EUCTR2006-005703-34-FR
• Lead Sponsor: Ageo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03-27
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Pathologically proven pancreatic adenocarcinoma (on primitive or metastatic lesion)
- Age between 18 and 75 years
- Life expectancy >12 weeks
- Performance status OMS < 2
- Pain well controlled
- Neutrophiles =1500/mm3, platelets = 100000/mm3, Hb = 9g/dl, ASAT and ALAT < 5 UNL, serum bilirubin = 1,5 UNL
- Normal renal function test (serum creatinine concentration = 130 mmol/l ou creatine clearance = 60 ml/min)
- Signed informed consent

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- No prior chemotherapy (except adjuvante chemotherapy with gemcitabine realised more than 12 months before inclusion day)
- No prior radiation therapy (except if there is at least one mesurable target outside irradiation area)
- Known brain metastasis (no need of systematic CTscan)
- Pregnant or feeding woman
- Previous carcinoma within the last 5 years (except basal cell carcinoma and in situ carcinoma cervix)
- Concomitant antitumoral treatment
- Recent (within 30 days prior inclusion) participation in another investigational study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified