A Phase 3 Trial of ALIMTA (LY231514, Pemetrexed) Plus GEMZAR Versus GEMZAR in Patients With Unresectable or Metastatic Cancer of the Pancreas.
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ClinicalTrials.gov Identifier: NCT00035035 |
Recruitment Status :
Completed
First Posted : May 3, 2002
Last Update Posted : July 19, 2006
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pancreatic Neoplasms Metastases, Neoplasm | Drug: GEMZAR Drug: ALIMTA | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
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. |


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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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

ClinicalTrials.gov Identifier: | NCT00035035 |
Obsolete Identifiers: | NCT00049426 |
Other Study ID Numbers: |
5148 H3E-MC-JMES |
First Posted: | May 3, 2002 Key Record Dates |
Last Update Posted: | July 19, 2006 |
Last Verified: | July 2006 |
Pancreas Cancer Unresectable or Metastatic Cancer of the Pancreas Alimta |
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 |
Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |