Trial Information

A Phase II, Multicenter, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Efficacy and Safety of Anti-TNF a Monoclonal Antibody (Infliximab) to Treat Cancer-Related Cachexia in Subjects With Pancreatic Cancer.

Cachexia is a condition that occurs in cancer patients and other chronically ill patients
and is characterized by rapid loss of fatty tissue and skeletal muscle. The key feature of
this condition is weight loss, but other symptoms, such as anorexia (loss of appetite),
fatigue, vomiting and anemia (low numbers of red blood cells) may also occur.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. In cycle 1 (8wks), patients will receive weekly infusions of
gemcitabine from wk 0 to 6 and infusions of infliximab or placebo at wks 0, 2, and 4. For
additional cycles, patients will receive an infusion of gemcitabine for the first 3wks and
infliximab or placebo at wk 0 of each 4 wk cycle for a maximum of 5 cycles. Patients with
stable disease may receive extended dosing if qualified.Safety evaluations will be performed
at specified intervals throughout the study and will consist of laboratory tests, vital
signs (such as blood pressure), physical examinations and the occurrence and severity of
adverse events as well as other study specific procedures. In cycle 1 (8wks), patients will
receive weekly infusions of gemcitabine from wk 0 to 6 and infusions of infliximab or
placebo at wks 0, 2, and 4. For additional cycles, patients will receive an infusion of
gemcitabine for the first 3wks and infliximab or placebo at wk 0 of each 4 wk cycle for a
maximum of 5 cycles.