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

Tracking Information

First Received Date ^ICMJE

September 18, 2007

Last Updated Date

November 17, 2009

Start Date ^ICMJE

October 2007

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Incidence of skin rash [ Time Frame: First 4 months of treatment ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Incidence of skin rash (folliculitis) of all grades during the first 4 months of treatment

Change History

Complete list of historical versions of study NCT00531934 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Response rate, rate of disease control, PFS, 1 year survival. [ Time Frame: Event driven ] [ Designated as safety issue: No ]
Specific skin toxicity assessment, AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Efficacy: Response rate (RECIST) in the 2 arms; rate of disease control; PFS and 1 year survival. Safety: Specific skin toxicity assessment; AEs and lab parameters.

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Randomized, Open Label Study to Evaluate the Effect of Doxycycline on Tarceva-induced Skin Rash in Patients With Non-small Cell Lung Cancer After Failure of First Line Chemotherapy

Brief Summary

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

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Non-small Cell Lung Cancer

Intervention ^ICMJE

Drug: erlotinib [Tarceva]
Drug: Doxycline

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

120

Estimated Completion Date

March 2010

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT ID ^ICMJE

NCT00531934

Responsible Party

Disclosures Group, Hoffmann-La Roche

Study ID Numbers ^ICMJE

ML20829

Study Sponsor ^ICMJE

Hoffmann-La Roche

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Clinical Trials

Hoffmann-La Roche

Information Provided By

Hoffmann-La Roche

Verification Date

November 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP