A Study of Management of Tarceva - Induced Rash in Patients With Non-Small Cell Lung Cancer.
Information source: Hoffmann-La Roche
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Non-Small Cell Lung Cancer
Intervention: erlotinib [Tarceva] (Drug); Doxycline (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Hoffmann-La Roche Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche, +1 973 235 5000
Overall contact:
Please reference Study ID Number: RLI_ML20829, Phone: 973-235-5000
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.
Clinical Details
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 design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Incidence of skin rash
Secondary outcome: Response rate, rate of disease control, PFS, 1 year survival.Specific skin toxicity assessment, AEs, laboratory parameters.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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.
Locations and Contacts
Please reference Study ID Number: RLI_ML20829, Phone: 973-235-5000
PARIS 75674, France; Recruiting
BOBIGNY 93009, France; Not yet recruiting
ANTIBES 06600, France; Recruiting
PONTOISE 95303, France; Recruiting
CAEN 14076, France; Recruiting
BORDEAUX 33300, France; Recruiting
DRAGUIGNAN 83007, France; Recruiting
RENNES 35033, France; Recruiting
PERIGUEUX 24000, France; Recruiting
METZ 57038, France; Recruiting
BREST 29200, France; Recruiting
PIERRE BENITE 69310, France; Recruiting
CHALON SUR SAONE 71100, France; Recruiting
ANGERS 49933, France; Not yet recruiting
LIMOGES 87042, France; Recruiting
PARIS 75248, France; Not yet recruiting
LE MANS 72000, France; Not yet recruiting
VANNES 56017, France; Recruiting
CHARTRES 28018, France; Recruiting
NIMES 30907, France; Recruiting
ROUEN 76000, France; Recruiting
BORDEAUX 33076, France; Recruiting
PERPIGNAN 66000, France; Recruiting
PARIS 75116, France; Recruiting
PARIS 75014, France; Recruiting
GAP 05000, France; Recruiting
TOURS 37044, France; Not yet recruiting
GLEIZE 69400, France; Recruiting
LEVALLOIS PERRET 92300, France; Not yet recruiting
Additional Information
Starting date: November 2007
Ending date: March 2010
Last updated: October 15, 2008
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