A Study of Management of Tarceva - Induced Rash in Patients With Non-Small Cell Lung Cancer.
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
1 other identifier
interventional
147
1 country
24
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 nonsmall-cell-lung-cancer
Started Oct 2007
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 18, 2007
CompletedFirst Posted
Study publicly available on registry
September 19, 2007
CompletedStudy Start
First participant enrolled
October 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedResults Posted
Study results publicly available
August 26, 2014
CompletedFebruary 25, 2015
February 1, 2015
2.8 years
September 18, 2007
June 23, 2014
February 5, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With at Least One Skin Rash (Folliculitis) of Any Grade During the First 4 Months of Treatment
Description of skin rash (folliculitis, including erythema, papulo-pustules, nodule, and crust) was according to Common Terminology Criteria for Adverse Events (CTCAE) version 3 scale. Medical pictures of the face (front and sides views) systematically, and of any region presenting with skin lesions were obtained. The pictures were reviewed by a centralized committee of evaluation.
Days 0, 14, 28 and Months 2, 3, and 4
Secondary Outcomes (31)
Number of Skin Rash (Folliculitis) Events During the First 4 Months of Treatment
Days 0, 14, 28 and Months 2, 3, and 4
Percentage of Participants With Skin Rash (Folliculitis) During the First 4 Months of Treatment By Type
Days 0, 14, 28 and Months 2, 3, and 4
Percentage of Participants With Skin Rash (Folliculitis) During the First 4 Months of Treatment By Maximal Intensity
Days 0, 14, 28 and Months 2, 3, and 4
Percentage of Participants With at Least One Skin Rash (Folliculitis) of Any Grade After the First 4 Months of Treatment
Months 7, 10, and 12
Number of Skin Rash (Folliculitis) Events After the First 4 Months of Treatment
Months 7, 10, and 12
- +26 more secondary outcomes
Study Arms (2)
1
EXPERIMENTAL2
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Unknown Facility
Antibes, 06600, France
Unknown Facility
Bordeaux, 33076, France
Unknown Facility
Bordeaux, 33300, France
Unknown Facility
Brest, 29200, France
Unknown Facility
Caen, 14076, France
Unknown Facility
Chalon-sur-Saône, 71100, France
Unknown Facility
Chartres, 28018, France
Unknown Facility
Draguignan, 83007, France
Unknown Facility
Gap, 05007, France
Unknown Facility
Gleizé, 69400, France
Unknown Facility
Limoges, 87042, France
Unknown Facility
Metz, 57038, France
Unknown Facility
Nîmes, 30900, France
Unknown Facility
Paris, 75116, France
Unknown Facility
Paris, 75674, France
Unknown Facility
Paris, 75679, France
Unknown Facility
Perpignan, 66000, France
Unknown Facility
Périgueux, 24000, France
Unknown Facility
Pierre-Bénite, 69495, France
Unknown Facility
Pontoise, 95300, France
Unknown Facility
Rennes, 35033, France
Unknown Facility
Rouen, 76000, France
Unknown Facility
Tours, 37044, France
Unknown Facility
Vannes, 56017, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann- LaRoche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 18, 2007
First Posted
September 19, 2007
Study Start
October 1, 2007
Primary Completion
August 1, 2010
Study Completion
August 1, 2010
Last Updated
February 25, 2015
Results First Posted
August 26, 2014
Record last verified: 2015-02