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

This study has been completed.
Sponsor:
Collaborator:
NCIC Clinical Trials Group
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00040183
First received: June 21, 2002
Last updated: August 6, 2012
Last verified: August 2012
History of Changes
  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 3

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Enrollment: 569
Study Start Date: October 2001
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
NCIC Clinical Trials Group
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00040183     History of Changes
Other Study ID Numbers: PA.3
Study First Received: June 21, 2002
Last Updated: August 6, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
Tarceva, EGFR, erlotinib, OSI-774

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

ClinicalTrials.gov processed this record on May 21, 2013