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

Phase 3
Completed
Conditions
Pancreatic Cancer
Registration Number
NCT00040183
Lead Sponsor
OSI Pharmaceuticals
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

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
569
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.'

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (140)

Arizona Clinical Research Center

πŸ‡ΊπŸ‡Έ

Tucson, Arizona, United States

Highlands Oncology Group

πŸ‡ΊπŸ‡Έ

Springdale, Arkansas, United States

Alta Bates Comprehensive Cancer Center

πŸ‡ΊπŸ‡Έ

Berkeley, California, United States

Loma Linda University Cancer Institute

πŸ‡ΊπŸ‡Έ

Loma Linda, California, United States

Metropolitan Hematology/Oncology Medical Group, Inc.

πŸ‡ΊπŸ‡Έ

Los Angeles, California, United States

UCLA Medical Center

πŸ‡ΊπŸ‡Έ

Los Angeles, California, United States

Kaiser Permanente

πŸ‡ΊπŸ‡Έ

San Diego, California, United States

DeQuattro Community Cancer Center

πŸ‡ΊπŸ‡Έ

Manchester, Connecticut, United States

New Britain General Hospital

πŸ‡ΊπŸ‡Έ

New Britain, Connecticut, United States

Eastern Connecticut Oncology

πŸ‡ΊπŸ‡Έ

Norwich, Connecticut, United States

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Arizona Clinical Research Center
πŸ‡ΊπŸ‡ΈTucson, Arizona, United States

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