Clinical trial NCT00531934: A Study of Management of Tarceva - Induced Rash in Patients With Non-Small Cell Lung Cancer.
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-09-19
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With at Least One Skin Rash (Folliculitis) of Any Grade During the First 4 Months of Treatment
timeFrame: Days 0, 14, 28 and Months 2, 3, and 4
Secondary outcomes:
measure: Number of Skin Rash (Folliculitis) Events During the First 4 Months of Treatment
timeFrame: Days 0, 14, 28 and Months 2, 3, and 4
measure: Percentage of Participants With Skin Rash (Folliculitis) During the First 4 Months of Treatment By Type
timeFrame: Days 0, 14, 28 and Months 2, 3, and 4
measure: Percentage of Participants With Skin Rash (Folliculitis) During the First 4 Months of Treatment By Maximal Intensity
timeFrame: Days 0, 14, 28 and Months 2, 3, and 4
measure: Percentage of Participants With at Least One Skin Rash (Folliculitis) of Any Grade After the First 4 Months of Treatment
timeFrame: Months 7, 10, and 12
measure: Number of Skin Rash (Folliculitis) Events After the First 4 Months of Treatment
timeFrame: Months 7, 10, and 12
measure: Number of Participants With Skin Rash (Folliculitis) After the First 4 Months of Treatment By Type
timeFrame: Months 7, 10, and 12
measure: Number of Participants With Skin Rash (Folliculitis) After the First 4 Months of Treatment By Intensity
timeFrame: Months 7, 10, and 12
measure: Time Free From Skin Rash (Folliculitis) During the First 4 Months of Treatment - Number of Participants With an Event
timeFrame: Days 0, 14, 28 and Months 2, 3, and 4
measure: Time Free From Skin Rash (Folliculitis) During the First 4 Months of Treatment - Time to Event
timeFrame: Days 0, 14, 28 and Months 2, 3, and 4
measure: Percentage of Participants Estimated to be Event Free at 4 Months
timeFrame: Days 0, 14, 28 and Months 2, 3, and 4
measure: Time Free From Skin Rash (Folliculitis) During the Whole Treatment Period - Number of Participants With an Event
timeFrame: Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12
measure: Time Free From Skin Rash (Folliculitis) During the Whole Treatment Period - Time to Event
timeFrame: Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12
measure: Percentage of Participants Estimated to be Event Free at 12 Months
timeFrame: Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12
measure: Duration of Skin Rash (Folliculitis) During the First 4 Months of Treatment
timeFrame: Days 0, 14, 28 and Months 2, 3, and 4
measure: Duration of Skin Rash (Folliculitis) During the Whole Treatment Period
timeFrame: Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12
measure: Percentage of Participants With Other Skin Lesions of Any Grade During the First 4 Months of Treatment
timeFrame: Days 0, 14, 28 and Months 2, 3, and 4
measure: Percentage of Participants With Other Skin Lesions During the First 4 Months of Treatment By Type
timeFrame: Days 0, 14, 28 and Months 2, 3, and 4
measure: Percentage of Participants With Other Skin Lesions During the First 4 Months of Treatment By Maximal Intensity
timeFrame: Days 0, 14, 28 and Months 2, 3, and 4
measure: Percentage of Participants With Erlotinib Dose Reduction by Reason for Reduction
timeFrame: Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12
measure: Percentage of Participants With Doxycycline Dose Reduction by Reason for Reduction
timeFrame: Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12
measure: Percentage of Participants With Global Disease Control by Visit
timeFrame: Months 2, 4, 7, 10, and 12
measure: Percentage of Participants by Best Global Response Under Treatment
timeFrame: Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12
measure: Progression-Free Survival (PFS) - Percentage of Participants With an Event
timeFrame: Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12
measure: Progression-Free Survival (PFS) - Time to Event
timeFrame: Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12
measure: Percentage of Participants Estimated to be Progression Free at 4 and 12 Months
timeFrame: Months 4 and 12
measure: Overall Survival (OS) - Percentage of Participants With an Event
timeFrame: Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12
measure: Overall Survival (OS) - Time to Event
timeFrame: Days 0, 14, 28 and Months 2, 3, 4, 7, 10, and 12
measure: Percentage of Participants Estimated to be Alive at 4 and 12 Months
timeFrame: Months 4 and 12
measure: Dermatology Life Quality Index (DLQI) Global Score
timeFrame: Baseline, Days 14 and 28 and Months 2, 3, and 4
measure: Percentage of Participants by DLQI Global Score Classification of Disease Effect on Quality of Life
timeFrame: Baseline, Days 14 and 28 and Months 2, 3, and 4
measure: Quality of Life Score as Assessed by Visual Analog Scale (VAS)
timeFrame: Baseline, Days 14 and 28, and Months 2, 3, and 4
Other outcomes:
Locations:
city: Antibes
country: France
city: Bordeaux
country: France
city: Bordeaux
country: France
city: Brest
country: France
city: Caen
country: France
city: Chalon Sur Saone
country: France
city: Chartres
country: France
city: Draguignan
country: France
city: GAP
country: France
city: Gleize
country: France
city: Limoges
country: France
city: Metz
country: France
city: Nimes
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Perigueux
country: France
city: Perpignan
country: France
city: Pierre Benite
country: France
city: Pontoise
country: France
city: Rennes
country: France
city: Rouen
country: France
city: Tours
country: France
city: Vannes
country: France
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: