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

Completed · Phase 3

Conditions studied: Pancreatic Cancer

In brief

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.

Key facts

Study ID

NCT00040183

Run by

OSI Pharmaceuticals

People needed

569

Starts

2001-11-29

Expected to finish

2004-01-15

Last updated by the study team

2018-01-10

Who can join

Age: 18 and older, up to 120. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.'

Where it is running

• Highlands Oncology Group — Springdale, Arkansas, United States
• Alta Bates Comprehensive Cancer Center — Berkeley, California, United States
• Loma Linda University Cancer Institute — Loma Linda, California, United States
• Metropolitan Hematology/Oncology Medical Group, Inc. — Los Angeles, California, United States
• UCLA Medical Center — Los Angeles, California, United States
• Kaiser Permanente — San Diego, California, United States
• DeQuattro Community Cancer Center — Manchester, Connecticut, United States
• New Britain General Hospital — New Britain, Connecticut, United States
• Eastern Connecticut Oncology — Norwich, Connecticut, United States
• Carl and Dorothy Bennett Cancer Center — Stamford, Connecticut, United States
• Florida Cancer Specialists — Fort Myers, Florida, United States
• Oncology Hematology Group of South Florida — Miami, Florida, United States
• Ocala Oncology — Ocala, Florida, United States
• Tampa General Hospital — Tampa, Florida, United States
• Atlanta Cancer Center — Atlanta, Georgia, United States
• Onc/Hem Associates of Central Illinois — Peoria, Illinois, United States
• Hematology Oncology Associates of Illinois — Skokie, Illinois, United States
• Carle Cancer Center — Urbana, Illinois, United States
• University of Iowa Hospital & Clinics — Iowa City, Iowa, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• University of Kentucky — Lexington, Kentucky, United States
• Norton Healthcare, Inc. — Louisville, Kentucky, United States
• Mary Bird Perkins Cancer Center — Baton Rouge, Louisiana, United States
• J Gurtler, Hematology and Oncology — Metairie, Louisiana, United States
• Arizona Clinical Research Center — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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