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

NCT ID: NCT00207077

Last Updated: 2015-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2007-05-31

Brief Summary

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

Detailed Description

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Conditions

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Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

Cetuximab + Erlotinib

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Erbitux

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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Christiana Care Health Services, Inc.

Newark, Delaware, United States

Site Status

Countries

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United States

Other Identifiers

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CA225-101

Identifier Type: -

Identifier Source: org_study_id

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