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

Sponsor
Hoffmann-La Roche
Study ID
NCT00531934
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

First listed
Sep 19, 2007
Start date
Oct 31, 2007
Status verified
Feb 2015
Primary completion
Aug 31, 2010
Completion
Aug 31, 2010

Study Design

Enrollment
147 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1
  • Active Comparator: 2

Primary Outcome Measure

Percentage of Participants With at Least One Skin Rash (Folliculitis) of Any Grade During the First 4 Months of Treatment [ Time Frame: Days 0, 14, 28 and Months 2, 3, and 4 ]

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