Clinical trial · Interventional
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.
NCT00060502CI-TRIAL-00004859completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cachexia | — | UNRESOLVED | — |
| Pancreatic Neoplasms | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Infliximab; Gemcitabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Change in Lean Body Mass (LBM) from baseline to the end of first cycle, as measured by bioelectrical impedance analysis (BIA).
Secondary outcomes (1)
- measure
- Change in 6-minute walk test distance from baseline to the end of the first cycle; Safety, Karnofsky performance status; Survival.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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
References
Publications (1)
- RESULTWiedenmann 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 18257397