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

• Status: Completed
• Trial end date: 2006-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centocor, Inc.
• Treatments: Gemcitabine; Infliximab

Criteria

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