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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 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Pancreas Cancer Unresectable or Metastatic Cancer of the Pancreas Alimta |
Antimetabolites Anti-Infective Agents Digestive System Neoplasms Immunologic Factors Pancreatic Neoplasms Folate Endocrine System Diseases Folinic Acid Folic Acid Antagonists Immunosuppressive Agents Antiviral Agents Pancrelipase |
Vitamin B9 Folic Acid Pemetrexed Digestive System Diseases Radiation-Sensitizing Agents 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 Pancreatic Neoplasms Physiological Effects of Drugs Pancrelipase Neoplastic Processes Neoplasms by Site Pathologic Processes Therapeutic Uses Neoplasm Metastasis Gemcitabine |
Endocrine Gland Neoplasms Digestive System Neoplasms Gastrointestinal Agents Endocrine System Diseases Enzyme Inhibitors Folic Acid Antagonists Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Pemetrexed Neoplasms Digestive System Diseases Radiation-Sensitizing Agents Pancreatic Diseases |