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

Phase 1

Completed

• Conditions: Neoplasms
• Interventions: Drug: Cetuximab + Erlotinib

• Registration Number: NCT00207077
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-21
• Primary Completion: 2007-05
• Study Completion: 2007-05
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-26
• Last Update Posted: 2015-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	Cetuximab + Erlotinib	-

Primary Outcome Measures

Name	Time	Method
Safety and efficacy of the combination of Tarceva and Erbitux

Secondary Outcome Measures

Name	Time	Method
Radiographic response

Trial Locations

Locations (1)

Christiana Care Health Services, Inc.; 🇺🇸 Newark, Delaware, United States