Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00060502
Status:
COMPLETED
Last Update Posted:
2011-05-17
First Post:
2003-05-07
Brief Title:
A Study of the Safety and Effectiveness of Infliximab Remicade in Patients With Pancreatic Cancer Related Cachexia
Sponsor:
Centocor Inc
Organization:
Centocor Inc
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
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 occurThe 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 qualifiedSafety 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None