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

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

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