A Randomized Placebo Controlled Study of OSI-774 (Tarceva (TM)) Plus Gemcitabine in Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer
A Randomized Placebo Controlled Study of OSI-774 (Tarceva (TM)) Plus Gemcitabine in Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer
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.
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.'
Baltimore, Maryland 21231, United States
HRMC Waratah, New South Wales 2310, Australia
Porto Alegre, Rio Grande do Sul CEP 90020-090, Brazil
Pentincton, British Columbia V2A 3G6, Canada
Saulte Ste. Marie, Ontario P6B 1Y5, Canada
Ste-Foy, Quebec G1V 4G5, Canada
Petach Tiqva, 49100, Israel
Dudley, West Midlands DY8 5QX, United Kingdom