A Study of the Safety and Effectiveness of Infliximab (Remicade) in Patients With Pancreatic Cancer Related Cachexia
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.
1 other identifier
interventional
73
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2003
Typical duration for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2003
CompletedFirst Submitted
Initial submission to the registry
May 7, 2003
CompletedFirst Posted
Study publicly available on registry
May 8, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2006
CompletedMay 17, 2011
April 1, 2010
May 7, 2003
May 16, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Lean Body Mass (LBM) from baseline to the end of first cycle, as measured by bioelectrical impedance analysis (BIA).
Secondary Outcomes (1)
Change in 6-minute walk test distance from baseline to the end of the first cycle; Safety, Karnofsky performance status; Survival.
Interventions
Eligibility Criteria
You may qualify if:
- Patients must have documented diagnosis of pancreatic cancer that is newly diagnosed
- Patients must have documented loss of \>=10% body weight compared to weight prior to diagnosis, or \>=5% weight loss within 90 days prior to randomization
- Patients must have Karnofsky performance status of 70 to 100
- eligible according to country specific tuberculosis (TB) screening rules.
You may not qualify if:
- Patients must not have received any previous chemotherapy, biologic therapy or radiation therapy for pancreatic cancer
- Patients must not have a history or current evidence of active TB, skin test or screening evidence of latent TB, or history of treated TB, active or latent
- Patients must not have evidence or history of congestive heart failure
- Patients must not have any opportunistic infection within 6 months prior to screening
- Patients must not be pregnant, nursing or planning pregnancy
- Patients must not have ongoing use of tube feedings or TPN
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centocor, Inc.lead
Related Publications (1)
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.
PMID: 18257397RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Centocor, Inc. Clinical Trial
Centocor, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 7, 2003
First Posted
May 8, 2003
Study Start
April 1, 2003
Study Completion
February 1, 2006
Last Updated
May 17, 2011
Record last verified: 2010-04