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Sponsored by: |
Eli Lilly and Company |
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Information provided by: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT00035035 |
Definition: This study will compare the drug GEMZAR to a combination of GEMZAR plus ALIMTA for the treatment of cancer of the pancreas. Patients may be able to participate in this study if they have cancer in their pancreas that cannot be removed by surgery OR that has spread to a new site in their body.
Condition | Intervention | Phase |
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Pancreatic Neoplasms Metastases, Neoplasm |
Drug: GEMZAR Drug: ALIMTA |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 3 Trial of ALIMTA (LY231514, Pemetrexed) Plus GEMZAR Versus GEMZAR in Patients With Unresectable or Metastatic Cancer of the Pancreas. |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | 5148, H3E-MC-JMES |
Study First Received: | May 2, 2002 |
Last Updated: | July 18, 2006 |
ClinicalTrials.gov Identifier: | NCT00035035 |
Health Authority: | United States: Food and Drug Administration |
Pancreas Cancer Unresectable or Metastatic Cancer of the Pancreas Alimta |
Digestive System Neoplasms Pancreatic Neoplasms Endocrine System Diseases Pancrelipase Pemetrexed Folic Acid Digestive System Diseases |
Neoplasm Metastasis Gastrointestinal Neoplasms Pancreatic Diseases Endocrinopathy Gemcitabine Endocrine Gland Neoplasms |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Gastrointestinal Agents Enzyme Inhibitors Folic Acid Antagonists |
Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Neoplasms Neoplastic Processes Pathologic Processes Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses |