Trial information
A Study of Management of Tarceva - Induced Rash in Patients With Non-Small Cell Lung Cancer.
Status: Recruiting
Protocol number: ML20829
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific 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
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. Target sample size is
120.
Study phase: II
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: Non-Small Cell Lung Cancer
Intervention type: Drug
Intervention name: erlotinib [Tarceva]
Primary outcome: 1. Incidence of skin rash Time frame: First 4 months of treatment
Key secondary outcomes: 1. Response rate, rate of disease control, PFS, 1 year survival. Time frame: Event driven
2. Specific skin toxicity assessment, AEs, laboratory parameters. Time frame: Throughout study
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: Males or Females
Age limits: Min: 18 Years Max: 75 Years
Accepts healthy volunteers: No
Anticipated start date: November, 2007
Trial registration date: 09/17/2007
Date last updated: 11/21/2008
Link to trial result
This trial is being conducted at the following locations:
France
- Angers
- Antibes
- Bobigny
- Bordeaux
- Brest
- Caen
- Chalon Sur Saone
- Chartres
- Draguignan
- Gap
- Gleize
- Le Mans
- Levallois Perret
- Limoges
- Metz
- Nimes
- Paris
- Perigueux
- Perpignan
- Pierre Benite
- Pontoise
- Rennes
- Rouen
- Tours
- Vannes
