Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
AZ-VUB Hoffmann-La Roche |
---|---|
Information provided by: | AZ-VUB |
ClinicalTrials.gov Identifier: | NCT00339586 |
Current chemotherapy for advanced non-small cell lung cancer, not amenable for curative local treatment (surgery or chemoradiotherapy), has a modest life-prolonging effect and can improve quality of life. There is however no potential for long-term cure for these patients.
Chemotherapy also produces variable and often significant toxicity. Current retrospective evidence suggests that significant clinical responses can be obtained when patients whose cancer cells have an EGFR TKD mutation are treated with an EGFR TKI.
The ease of administration and toxicity profile of TKI compare favourably with that of chemotherapy, even single agents such as for example gemcitabine The present study will establish the clinical benefit rate of TKI as a first line treatment in patients with EGFR mutations and thus estimate the proportion of patients who might benefit for a prolonged period from a treatment with a modest toxicity profile.
Condition | Intervention | Phase |
---|---|---|
Lung Neoplasms Non-Small Cell Lung Cancer Adenocarcinoma, Bronchiolo-Alveolar |
Drug: Erlotinib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Prospective Evaluation of Small Molecule EGFR-1 Tyrosine Kinase Inhibition as a First-Line Treatment in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Harbouring a Mutant EGFR Gene |
Estimated Enrollment: | 40 |
Study Start Date: | January 2006 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Granulocyte count > 1.5 x 109/L and platelet count > 100 x 109/L Serum bilirubin must be < 1.5 upper limit of normal (ULN). If alkaline phosphatase is > 2.5 x ULN, SGOT (AST) and SGPT (ALT) must be < 1.5 x ULN.
Serum creatinine < 1.5 ULN or creatinine clearance > 60 ml/min.
If frozen samples are available, these will be collected by central data management.
Exclusion Criteria:
Contact: Jacques De Grève, MD PhD | 0032 2 477 64 15 | jacques.degreve@az.vub.ac.be |
Contact: Nicolas Fontaine, Mr | 0032 2 477 54 61 | nicolas.fontaine@az.vub.ac.be |
Belgium | |
AZ VUB | Recruiting |
Jette, Belgium, 1090 | |
Contact: Jacques De Grève, MD PhD 0032 2 477 64 15 jacques.degreve@az.vub.ac.be | |
Contact: Nicolas Fontaine, Mr 0032 2 477 54 61 nicolas.fontaine@az.vub.ac.be | |
Principal Investigator: Jacques De Grève, MD PhD |
Principal Investigator: | Jacques De Grève, MD PhD | AZ-VUB |
Study ID Numbers: | FIELT, VUB 05-002 |
Study First Received: | June 19, 2006 |
Last Updated: | June 19, 2006 |
ClinicalTrials.gov Identifier: | NCT00339586 History of Changes |
Health Authority: | Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment |
Non-small cell lung cancer tyrosine kinase inhibition first-line treatment mutant EGFR-gene |
Erlotinib Thoracic Neoplasms Respiratory Tract Diseases Adenocarcinoma, Bronchiolo-Alveolar Lung Neoplasms Lung Diseases |
Tyrosine Non-small Cell Lung Cancer Adenocarcinoma Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Adenocarcinoma, Bronchiolo-Alveolar Carcinoma Neoplasms Neoplasms by Site |
Respiratory Tract Diseases Lung Neoplasms Lung Diseases Adenocarcinoma Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |