Status:
COMPLETED
Erlotinib (Tarceva) as a Single Agent or Intercalated With Combination Chemotherapy in Patients With EGFR Positive NSCLC
Lead Sponsor:
OSI Pharmaceuticals
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This will be the first prospective study where patients will be selected on the basis of two measures of the epidermal growth factor receptor (EGFR) pathway. The study will assess prospectively the ef...
Eligibility Criteria
Inclusion
- Age \>= 18
- Histologically or cytologically documented non-small cell lung cancer (NSCLC)
- Eastern Cooperative Oncology Group (ECOG)performance status (PS)0, 1, 2
- Radiologically measurable or evaluable disease No prior chemotherapy
- 1 or 2 epithelial growth factor receptor (EGFR) pathway markers positive at screening
- Tumor tissue block or fine needle aspirate
Exclusion
- Any concurrent anticancer therapy or radiation
- Other active malignancy
- Uncontrolled brain metastases
- GI abnormalities
- Severe abnormalities of the cornea
- Significant cardiac disease
- Active infection
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
143 Patients enrolled
Trial Details
Trial ID
NCT00294762
Start Date
January 1 2006
End Date
March 1 2009
Last Update
August 9 2012
Active Locations (43)
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1
Central Hematology Oncology Medical Group Inc.
Alhambra, California, United States, 91801
2
Comprehensive Blood and Cancer Center(Part of TORI network)
Bakersfield, California, United States, 93309
3
Bay Area Cancer Research Group
Concord, California, United States, 94520
4
Virginia K. Crosson Cancer Center
Fullerton, California, United States, 92835