Maintenance of Tarceva (Erlotinib) in Patients With Locally Advanced Head and Neck Cancer

NCT ID: NCT00750555

Last Updated: 2019-02-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2009-12-31

Brief Summary

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Phase II Study of Maintenance Tarceva (Erlotinib) in patients with locally advanced Head and Neck Cancer after treatment with curative intent

Detailed Description

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Conditions

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Head and Neck Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type OTHER

Erlotinib

Intervention Type DRUG

150 mg per day orally until disease progression occurs, up to a maximum of 12 months

Interventions

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Erlotinib

150 mg per day orally until disease progression occurs, up to a maximum of 12 months

Intervention Type DRUG

Other Intervention Names

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Tarceva

Eligibility Criteria

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Inclusion Criteria

* Stage III, IV SCCHN
* Completed curative treatment

Exclusion Criteria

* Prior chemotherapy or radiotherapy
* Recurrent disease
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genentech, Inc.

INDUSTRY

Sponsor Role collaborator

Geisinger Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Amy Law, MD

Role: PRINCIPAL_INVESTIGATOR

Geisinger Clinic

Locations

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Geisinger Health System

Danville, Pennsylvania, United States

Site Status

Countries

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United States

Related Links

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http://www.geisinger.org

Click here for more information about Geisinger Health System

Other Identifiers

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OSI4178S

Identifier Type: -

Identifier Source: secondary_id

2008-0153

Identifier Type: -

Identifier Source: org_study_id

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