A Phase 3 Trial of ALIMTA (LY231514, Pemetrexed) Plus GEMZAR Versus GEMZAR in Patients With Unresectable or Metastatic Cancer of the Pancreas. - Tabular View

Tracking Information
First Received Date ^ICMJE	May 2, 2002
Last Updated Date	July 18, 2006
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00035035 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	A Phase 3 Trial of ALIMTA (LY231514, Pemetrexed) Plus GEMZAR Versus GEMZAR in Patients With Unresectable or Metastatic Cancer of the Pancreas.
Official Title ^ICMJE	A Phase 3 Trial of ALIMTA (LY231514, Pemetrexed) Plus GEMZAR Versus GEMZAR in Patients With Unresectable or Metastatic Cancer of the Pancreas.
Brief Summary	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.
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Pancreatic Neoplasms Metastases, Neoplasm
Intervention ^ICMJE	Drug: GEMZAR Drug: ALIMTA
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Argentina, Australia, Austria, Belgium, Colombia, France, Germany, Greece, Italy, Netherlands, Peru, Portugal, Spain, Sweden, Taiwan, United Kingdom, Venezuela

Administrative Information
NCT ID ^ICMJE	NCT00035035
Responsible Party
Study ID Numbers ^ICMJE	5148, H3E-MC-JMES
Study Sponsor ^ICMJE	Eli Lilly and Company
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Eli Lilly and Company
Verification Date	July 2006
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP