A Study of Management of Tarceva - Induced Rash in Patients With Non-Small Cell Lung Cancer.

NCT ID: NCT00531934

Last Updated: 2015-02-25

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

147 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2010-08-31

Brief Summary

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This 2 arm study will evaluate the management of Tarceva-induced skin rash in patients with non-small cell lung cancer who have failed first-line chemotherapy for advanced disease. Eligible patients will be randomized to receive a)doxycycline 100mg po daily or b)no preventative treatment; all patients will receive Tarceva 150mg/kg po daily. The anticipated time on study treatment is until disease progression or intolerable toxicity, and the target sample size is 100-500 individuals.

Detailed Description

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Conditions

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Non-Small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Doxycline

Intervention Type DRUG

100mg po daily

erlotinib [Tarceva]

Intervention Type DRUG

150mg po daily

2

Group Type ACTIVE_COMPARATOR

erlotinib [Tarceva]

Intervention Type DRUG

150mg po daily

Interventions

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Doxycline

100mg po daily

Intervention Type DRUG

erlotinib [Tarceva]

150mg po daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* adult patients, 18-75 years of age;
* confirmed non-small cell lung cancer;
* failure after first line chemotherapy for advanced disease, and scheduled for second line therapy with Tarceva.

Exclusion Criteria

* rash of any etiology at study entry;
* history of significant heart disease;
* any other malignancies (other than adequately treated squamous cell skin cancer, or in situ cancer of the cervix);
* history of allergic reactions to tetracyclines.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Antibes, , France

Site Status

Bordeaux, , France

Site Status

Bordeaux, , France

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Brest, , France

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Caen, , France

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Chalon-sur-Saône, , France

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Chartres, , France

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Draguignan, , France

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Gap, , France

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Gleizé, , France

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Limoges, , France

Site Status

Metz, , France

Site Status

Nîmes, , France

Site Status

Paris, , France

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Paris, , France

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Paris, , France

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Perpignan, , France

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Périgueux, , France

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Pierre-Bénite, , France

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Pontoise, , France

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Rennes, , France

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Rouen, , France

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Tours, , France

Site Status

Vannes, , France

Site Status

Countries

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France

Other Identifiers

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ML20829

Identifier Type: -

Identifier Source: org_study_id

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