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

• Status: Completed
• Trial end date: 2004-01-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: OSI Pharmaceuticals
• Collaborators: Canadian Cancer Trials Group; NCIC Clinical Trials Group
• Treatments: Erlotinib Hydrochloride; Gemcitabine

Criteria

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.'