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A Randomized Placebo Controlled Study of OSI-774 (Tarceva (TM)) Plus Gemcitabine in Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer

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Trial Conditions
  • Pancreatic Cancer
What is the purpose of this trial?

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.

Date & Status

Completed

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Both

Eligibility

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.'

Gender: Both
Trial Interventions
Drug
  • Tarceva (erlotinib HCl, OSI-774)
Other Information

Sponsor: OSI Pharmaceuticals
Phase: Phase 3
Trial ID: NCT00040183
Volunteers:  Not Accepting Healthy Volunteers

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