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

This study has been completed.

Sponsored by: Centocor, Inc.
Information provided by: Centocor, Inc.
ClinicalTrials.gov Identifier: NCT00060502
  Purpose

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.


Condition Intervention Phase
Cachexia
Pancreatic Neoplasms
Drug: Infliximab; Gemcitabine
Phase II

MedlinePlus related topics:   Cancer    Pancreatic Cancer   

ChemIDplus related topics:   Gemcitabine hydrochloride    Gemcitabine    Infliximab   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
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.

Further study details as provided by Centocor, Inc.:

Primary Outcome Measures:
  • Change in Lean Body Mass (LBM) from baseline to the end of first cycle, as measured by bioelectrical impedance analysis (BIA).

Secondary Outcome Measures:
  • Change in 6-minute walk test distance from baseline to the end of the first cycle; Safety, Karnofsky performance status; Survival.

Estimated Enrollment:   90
Study Start Date:   April 2003
Study Completion Date:   February 2006

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 occur.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. 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, patiens 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 qualified.Safety 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, patiens 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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00060502

Sponsors and Collaborators
Centocor, Inc.

Investigators
Study Director:     Centocor, Inc. Clinical Trial     Centocor, Inc.    
  More Information

A Phase II, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Anti-TNFa Monoclonal Antibody (Infliximab) to Treat Cancer-related Cachexia in Subjects with Pancreatic Cancer  This link exits the ClinicalTrials.gov site
 

Publications of Results:

Study ID Numbers:   CR004798
First Received:   May 7, 2003
Last Updated:   March 24, 2008
ClinicalTrials.gov Identifier:   NCT00060502
Health Authority:   United States: Food and Drug Administration

Keywords provided by Centocor, Inc.:
infliximab  
anorexia  
cachexia  
Remicade.
pancreatic cancer
anemia

Study placed in the following topic categories:
Digestive System Neoplasms
Infliximab
Pancreatic Neoplasms
Anemia
Endocrine System Diseases
Cachexia
Emaciation
Antibodies, Monoclonal
Body Weight
Signs and Symptoms
Antibodies
Digestive System Diseases
Weight Loss
Anorexia
Body Weight Changes
Pancreatic Diseases
Gastrointestinal Neoplasms
Endocrinopathy
Gemcitabine
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Enzyme Inhibitors
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses
Antirheumatic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on September 05, 2008




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