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Study of Cetuximab in Combination With Tarceva in Patients With Solid Tumors

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00207077
First Posted: September 21, 2005
Last Update Posted: October 28, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Eli Lilly and Company
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of Cetuximab in Combination With Erlotinib in Patients With Advanced Solid Malignancies

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

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
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A 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.
Other Name: Erbitux

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00207077


Locations
United States, Delaware
Christiana Care Health Services, Inc.
Newark, Delaware, United States, 19718
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00207077     History of Changes
Other Study ID Numbers: CA225-101
First Submitted: September 12, 2005
First Posted: September 21, 2005
Last Update Posted: October 28, 2015
Last Verified: October 2015

Keywords provided by Eli Lilly and Company:
Advanced Solid Tumors

Additional relevant MeSH terms:
Cetuximab
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action