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OSI-774 (Tarceva) 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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00040183
Enrollment
569
Registered
2002-06-25
Start date
2001-11-29
Completion date
2004-01-15
Last updated
2018-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cancer

Keywords

Tarceva, EGFR, erlotinib, OSI-774

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.

Interventions

DRUGTarceva (erlotinib HCl, OSI-774)

Sponsors

Canadian Cancer Trials Group
CollaboratorNETWORK
OSI Pharmaceuticals
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No

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.'

Countries

Argentina, Australia, Belgium, Brazil, Canada, Chile, Germany, Greece, Israel, Italy, Mexico, New Zealand, Poland, Romania, Singapore, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026