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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00207077

Enrollment

Registered

2005-09-21

Start date

2005-08-31

Completion date

2007-05-31

Last updated

2015-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasms

Keywords

Advanced Solid Tumors

Brief summary

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

Interventions

DRUGCetuximab + 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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Safety and efficacy of the combination of Tarceva and Erbitux	—

Secondary

Measure	Time frame
Radiographic response	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026