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NCT00207077 Clinical Trial

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

Neoplasms Clinical Trial

Official title:
A Phase I Study of Cetuximab in Combination With Erlotinib in Patients With Advanced Solid Malignancies

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00207077
Other study ID # CA225-101
Secondary ID
Status Completed
Phase Phase 1
First received September 12, 2005
Last updated October 26, 2015
Start date August 2005
Est. completion date May 2007

Study information
Verified date October 2015
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 33
Est. completion date May 2007
Est. primary completion date May 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States Christiana Care Health Services, Inc. Newark Delaware

Sponsors (1)
Lead Sponsor Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety and efficacy of the combination of Tarceva and Erbitux
Secondary Radiographic response
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