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| 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 |
| 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. |
| Estimated Enrollment: | 90 |
| Study Start Date: | April 2003 |
| Study Completion Date: | February 2006 |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Study ID Numbers: | CR004798 |
| Study First Received: | May 7, 2003 |
| Last Updated: | March 24, 2008 |
| ClinicalTrials.gov Identifier: | NCT00060502 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
infliximab anorexia cachexia |
Remicade. pancreatic cancer anemia |
|
Anti-Inflammatory Agents Antimetabolites Immunologic Factors Infliximab Pancreatic Neoplasms Cachexia Body Weight Antibodies, Monoclonal Signs and Symptoms Weight Loss Body Weight Changes Gemcitabine Endocrine Gland Neoplasms Immunoglobulins |
Digestive System Neoplasms Anemia Endocrine System Diseases Emaciation Antiviral Agents Immunosuppressive Agents Antibodies Digestive System Diseases Radiation-Sensitizing Agents Anorexia Gastrointestinal Neoplasms Pancreatic Diseases Endocrinopathy Antirheumatic Agents |
|
Anti-Inflammatory Agents Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Infliximab Antineoplastic Agents Pancreatic Neoplasms Physiological Effects of Drugs Cachexia Body Weight Signs and Symptoms Neoplasms by Site Therapeutic Uses |
Weight Loss Body Weight Changes Gemcitabine Dermatologic Agents Endocrine Gland Neoplasms Digestive System Neoplasms Gastrointestinal Agents Endocrine System Diseases Enzyme Inhibitors Emaciation Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Neoplasms Digestive System Diseases |