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

This study has been completed.
Sponsor:
Information provided by:
Centocor, Inc.
ClinicalTrials.gov Identifier:
NCT00060502
First received: May 7, 2003
Last updated: May 16, 2011
Last verified: April 2010
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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.

Resource links provided by NLM:


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.

Enrollment: 73
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, 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 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, 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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00060502     History of Changes
Other Study ID Numbers: CR004798
Study First Received: May 7, 2003
Last Updated: May 16, 2011
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Pancreatic Neoplasms
Cachexia
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Infliximab
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Dermatologic Agents
Gastrointestinal Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 18, 2014