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Study of Cetuximab in Combination With Tarceva in Patients With Solid Tumors
This study has been completed.
Sponsored by: Bristol-Myers Squibb
Information provided by: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00207077
  Purpose

The purpose of this study is to find a safe and effective dose of the combination of cetuximab (Erbitux) and Tarceva (erlotinib).


Condition Intervention Phase
Neoplasms
 Drug: Cetuximab + Erlotinib
 Phase I

MedlinePlus related topics: Cancer
Drug Information available for: Erlotinib Erlotinib hydrochloride Cetuximab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase I Study of Cetuximab in Combination With Erlotinib in Patients With Advanced Solid Malignancies

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Safety and efficacy of the combination of Tarceva and Erbitux

Secondary Outcome Measures:
  • Radiographic response

Estimated Enrollment: 33
Study Start Date: August 2005
Study Completion Date: May 2007
Arms Assigned Interventions
A: Experimental Drug: Cetuximab + Erlotinib
IV solution + tablet, IV+ oral, ERB 100 mg/m2, 200 mg/m2, 250 mg/m2 IV + Erl 150 mg tablet, ERB weekly/ Erl once daily, Until disease progression.

  Eligibility

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

Inclusion Criteria:

  • Measurable disease
  • Life expectancy of at least 3 months
  • Must have at least one prior chemotherapy containing a platinum

Exclusion Criteria:

  • Known or documented brain metastases
  • Prior cetuximab therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00207077

Locations
United States, Delaware
Christiana Care Health Services, Inc.
Newark, Delaware, United States, 19718
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

Study ID Numbers: CA225-101
Study First Received: September 12, 2005
Last Updated: July 10, 2008
ClinicalTrials.gov Identifier: NCT00207077  
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Advanced Solid Tumors

Study placed in the following topic categories:
Erlotinib
Cetuximab

Additional relevant MeSH terms:
Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
 Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009



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