NCT01543412

Second Line Chemotherapy for Advanced Pancreatic Cancer

Folfiri as Second-Line Chemotherapy for Advanced Pancreatic Cancer. A GISCAD Phase II Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

• Pancreatic Adenocarcinoma

Interventions

Type	Name	Description
DRUG	FOLFIRI	Irinotecan 180 mg/m2 iv on day 1, Leucovorin(l-form) 200 mg/m2 iv on day 1,2 5-FU 400 mg/m2 iv bolus on day 1,2 5-FU 600 mg/m2 iv by ci for 22 hrs on day 1,2 repeated every 2 wks

Timeline

• Start date: 2010-01-01
• Primary completion: 2011-06-01
• Completion: 2011-12-01
• First posted: 2012-03-05
• Last updated: 2012-03-05

Locations

9 sites across 1 country: Italy