A Phase 3 Trial of ALIMTA (LY231514, Pemetrexed) Plus GEMZAR Versus GEMZAR in Patients With Unresectable or Metastatic Cancer of the Pancreas.
This study has been completed.
Sponsor:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00035035
First Posted: May 3, 2002
Last Update Posted: July 19, 2006
Information provided by:
Eli Lilly and Company
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Purpose
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 |
|---|---|---|
| Pancreatic Neoplasms Metastases, Neoplasm | Drug: GEMZAR Drug: ALIMTA | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| Official Title: | A Phase 3 Trial of ALIMTA (LY231514, Pemetrexed) Plus GEMZAR Versus GEMZAR in Patients With Unresectable or Metastatic Cancer of the Pancreas. |
Resource links provided by NLM:
MedlinePlus related topics:
Pancreatic Cancer
Drug Information available for:
Pancreatin
Pancrelipase
Gemcitabine
Gemcitabine hydrochloride
Pemetrexed
Pemetrexed disodium
U.S. FDA Resources
Further study details as provided by Eli Lilly and Company:
Eligibility
Information from the National Library of Medicine
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Pancreas cancer that cannot be removed by surgery OR that has spread to a new site in your body.
- You must have one tumor that can be physically measured or scanned by the doctor.
- You have not had any chemotherapy, immunotherapy, biologic therapy, or hormonal therapy for pancreas cancer, including 5-FU.
- You cannot have any radiation for 4 weeks before starting this study, and you cannot have radiation to the whole pelvis.
Exclusion Criteria:
- Treatment with any medication or device that has not been approved by regulatory agencies, like the FDA, at the time you enter the study.
- Documentation that the cancer has spread to your brain.
- Pregnant or breastfeeding.
- A second primary cancer.
- Unable to stop aspirin or non-steroidal anti-inflammatory agents (like ibuprofen) for 5-8 days.
Contacts and Locations
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00035035
Show 115 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
More Information
| ClinicalTrials.gov Identifier: | NCT00035035 History of Changes |
| Obsolete Identifiers: | NCT00049426 |
| Other Study ID Numbers: |
5148 H3E-MC-JMES |
| First Submitted: | May 2, 2002 |
| First Posted: | May 3, 2002 |
| Last Update Posted: | July 19, 2006 |
| Last Verified: | July 2006 |
Keywords provided by Eli Lilly and Company:
|
Pancreas Cancer Unresectable or Metastatic Cancer of the Pancreas Alimta |
Additional relevant MeSH terms:
|
Neoplasms Neoplasm Metastasis Pancreatic Neoplasms Neoplastic Processes Pathologic Processes Digestive System Neoplasms Neoplasms by Site Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Gemcitabine Pemetrexed Pancrelipase |
Pancreatin Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors Gastrointestinal Agents Antimetabolites, Antineoplastic Antimetabolites Antiviral Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |