A Study of the Safety and Effectiveness of Infliximab (Remicade) in Patients With Pancreatic Cancer Related Cachexia

Phase 2 Completed 73 enrolled Centocor, Inc.

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to evaluate the effectiveness and safety of infliximab, the active ingredient in Remicade, for the treatment of cachexia in pancreatic cancer patients who are receiving chemotherapy with gemcitabine.

Timeline

Start: 2003-04
Primary completion: —
Completion: 2006-02

Outcome

Missed primary endpoint

paper No statistically significant differences in LBM or secondary endpoints were observed among the groups. PMID 18257397 ↗

Publications

Results Wiedenmann B, Malfertheiner P, Friess H, Ritch P, Arseneau J, Mantovani G, Caprioni F, Van Cutsem E, Richel D, DeWitte M, Qi M, Robinson D Jr, Zhong B, De Boer C, Lu JD, Prabhakar U, Corringham R, Von Hoff D. A multicenter, phase II study of infliximab plus gemcitabine in pancreatic cancer cachexia. J Support Oncol. 2008 Jan;6(1):18-25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Infliximab	Monoclonal antibody	3 mg/kg	—
Subject	Infliximab	Monoclonal antibody	5 mg/kg	—
Background	Gemcitabine	Small molecule	1000 mg/m2	—