A Study of the Safety and Effectiveness of Infliximab (Remicade) in Patients With Pancreatic Cancer Related Cachexia
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|ClinicalTrials.gov Identifier: NCT00060502|
Recruitment Status : Completed
First Posted : May 8, 2003
Last Update Posted : May 17, 2011
|Condition or disease||Intervention/treatment||Phase|
|Cachexia Pancreatic Neoplasms||Drug: Infliximab; Gemcitabine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||73 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||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.|
|Study Start Date :||April 2003|
|Actual Study Completion Date :||February 2006|
- Change in Lean Body Mass (LBM) from baseline to the end of first cycle, as measured by bioelectrical impedance analysis (BIA).
- Change in 6-minute walk test distance from baseline to the end of the first cycle; Safety, Karnofsky performance status; Survival.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00060502
|Study Director:||Centocor, Inc. Clinical Trial||Centocor, Inc.|