OSI-774 (Tarceva) Plus Gemcitabine in Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer. - Tabular View

Tracking Information
First Received Date ^ICMJE	June 21, 2002
Last Updated Date	January 25, 2006
Start Date ^ICMJE	October 2001
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00040183 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	OSI-774 (Tarceva) Plus Gemcitabine in Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer.
Official Title ^ICMJE	A Randomized Placebo Controlled Study of OSI-774 (Tarceva (TM)) Plus Gemcitabine in Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer
Brief Summary	The purpose of this study is to determine if OSI-774 will improve overall survival when combined with a standard dose of the chemotherapy drug gemcitabine, to individuals with pancreatic cancer.
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Condition ^ICMJE	Pancreatic Cancer
Intervention ^ICMJE	Drug: Tarceva (erlotinib HCl, OSI-774)
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	500
Completion Date	September 2004
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria: Histologically or cytologically confirmed diagnosis of adenocarcinoma of the pancreas;cancer which is unresectable, locally advanced or metastatic. Must have evidence of disease (clinical or radiological). Male or female, 18 years or older. Patients may have received prior radiation treatment for management of local disease providing that disease progression has been documented. All toxicities have resolved, and the last fraction of radiation treatment was completed at least 4 weeks prior to randomization. Patients may not have received prior chemotherapy, other then 5FU (+/- folic acid) or gemcitabine given concurrently with radiation treatment as a 'radiosensitiser.'
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, Belgium, Brazil, Canada, Chile, Germany, Greece, Israel, Italy, Mexico, New Zealand, Poland, Romania, Singapore, United Kingdom

Administrative Information
NCT ID ^ICMJE	NCT00040183
Responsible Party
Study ID Numbers ^ICMJE	OSI-774-PA3
Study Sponsor ^ICMJE	OSI Pharmaceuticals
Collaborators ^ICMJE	NCIC Clinical Trials Group
Investigators ^ICMJE
Information Provided By	OSI Pharmaceuticals
Verification Date	January 2006
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP