Randomized Phase II Study of FOLFOX Versus FOLFIRI.3 in Gemcitabine-refractory Pancreatic Cancer

Phase 2 Completed 61 enrolled Asan Medical Center

RandomizedParallel-groupOpen-labelTreatment

Summary

The investigators are to evaluate the efficacy and safety of FOLFOX or FOLFIRI.3 combination chemotherapy as second-line salvage chemotherapy in patients with advanced pancreatic carcinoma.

Timeline

Start: 2007-03
Primary completion: 2009-03
Completion: 2009-09

Publications

Results Yoo C, Hwang JY, Kim JE, Kim TW, Lee JS, Park DH, Lee SS, Seo DW, Lee SK, Kim MH, Han DJ, Kim SC, Lee JL. A randomised phase II study of modified FOLFIRI.3 vs modified FOLFOX as second-line therapy in patients with gemcitabine-refractory advanced pancreatic cancer. Br J Cancer. 2009 Nov 17;101(10):1658-63. doi: 10.1038/sj.bjc.6605374. Epub 2009 Oct 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Irinotecan	Small molecule	70 mg/m2	—
Subject	Oxaliplatin	Small molecule	85 mg/m2	—
Subject	fluorouracil	Small molecule	400 mg/m2	Intravenous
Subject	fluorouracil	Small molecule	2000 mg/m2	Intravenous
Background	Leucovorin	Small molecule	400 mg/m2	—

Randomized Phase II Study of FOLFOX Versus FOLFIRI.3 in Gemcitabine-refractory Pancreatic Cancer

Summary

Timeline

Publications

Drugs

Indications