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

This study has been completed.

Sponsors and Collaborators: OSI Pharmaceuticals
National Cancer Institute of Canada
Information provided by: OSI Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00040183
  Purpose

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.


Condition Intervention Phase
Pancreatic Cancer
Drug: Tarceva (erlotinib HCl, OSI-774)
Phase III

MedlinePlus related topics:   Cancer    Pancreatic Cancer   

ChemIDplus related topics:   Gemcitabine hydrochloride    Gemcitabine    Erlotinib    Erlotinib hydrochloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:   A Randomized Placebo Controlled Study of OSI-774 (Tarceva (TM)) Plus Gemcitabine in Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer

Further study details as provided by OSI Pharmaceuticals:

Estimated Enrollment:   500
Study Start Date:   October 2001
Estimated Study Completion Date:   September 2004

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.'

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00040183

Show 140 study locations  Show 140 Study Locations

Sponsors and Collaborators
OSI Pharmaceuticals
National Cancer Institute of Canada
  More Information


Related Info  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   OSI-774-PA3
First Received:   June 21, 2002
Last Updated:   January 25, 2006
ClinicalTrials.gov Identifier:   NCT00040183
Health Authority:   United States: Food and Drug Administration

Keywords provided by OSI Pharmaceuticals:
Tarceva, EGFR, erlotinib, OSI-774  

Study placed in the following topic categories:
Erlotinib
Digestive System Diseases
Digestive System Neoplasms
Pancreatic Neoplasms
Endocrine System Diseases
Pancreatic Diseases
Gastrointestinal Neoplasms
Endocrinopathy
Gemcitabine
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Protein Kinase Inhibitors
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 10, 2008




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