Status:
UNKNOWN
Phase II Trial of Tarceva in Patients With Non-Small Cell Lung Cancer
Lead Sponsor:
Grupo Gallego de Cancer de Pulmon
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
Brief Summary
A open label non- randomized Phase II trial. It is anticipated that approximately 46 patients will be treated. STUDY OBJECTIVES Primary: Objective response rate Secondary: Progression free survival...
Detailed Description
Study Design: Phase II trial, open label, non-randomized and multicenter. Expected total enrollment: 46 Study start: January, 2006 Study completation: January, 2008
Eligibility Criteria
Inclusion
- Age 18 years.
- Patients must have histologically confirmed diagnosis of non-small cell lung cancer, which is not surgically resectable (stage IA- IIIB).
- Measurable disease.
- Written informed consent must be obtained prior to the inclusion into the trial.
- Karnofsky performance status of 80%.
- Patients must have been treated with no prior chemotherapy or radioterapy.
- Patients must have adequate bone marrow, liver and renal function.
- Bone Marrow: WBC \> 3000 x 103/mm3,
- Platelets \> 100 x 103/mm3,
- Hgb \> 10.0 gm/dl,
- ANC \>1500 x 103/mm3,
- Hepatic:Bilirubin \< 2 mg/dl (34 µmol/l); AST, ALT, and Alkaline Phosphatase \< 5 x normal,
- Renal:Creatinine \< 1.5 mg/dl (132 µmol/l).
Exclusion
- Female patients who are pregnant or lactating.
- Patients who have used other investigational agents within 21 days prior to study entry.
- Patients who have received prior treatment with erlotinib or other anti-EGFR agent.
- Significant comorbidity.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00466284
Start Date
January 1 2006
Last Update
April 27 2007
Active Locations (1)
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1
Grupo Gallego de Cancer de Pulmon
Santiago de Compostela, A CORUÑA, Spain, 15701