Status:
COMPLETED
Erlotinib vs. Standard Chemotherapy in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) and Eastern Cooperative Oncology Group (ECOG)Performance Status (PS) 2
Lead Sponsor:
OSI Pharmaceuticals
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this noncomparative study is to obtain preliminary estimates of the efficacy of erlotinib and standard chemotherapy in patients with advanced, previously untreated nonsmall cell lung ca...
Eligibility Criteria
Inclusion
- Stage IIIB or IV Nonsmall cell lung cancer (NSCLC)
- No prior chemotherapy
- Eastern Cooperative Oncology Group (ECOG) Performance Status 2
- Clinically or radiologically measurable disease per RECIST criteria
Exclusion
- Gastro-intestinal abnormalities
- Any concurrent anticancer therapy
- Prior treatment with epidermal growth factor receptor (EGFR) inhibitors of any kind
- Other active malignancies
- Uncontrolled brain metastases
- Severe abnormalities of the cornea
- Significant cardiac disease
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT00085839
Start Date
February 1 2004
End Date
March 1 2007
Last Update
August 9 2012
Active Locations (19)
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1
California Cancer Care, Inc.
Greenbrae, California, United States, 94904
2
Sharp Clinical Oncology Research
San Diego, California, United States, 92123
3
Holy Cross Hospital
Fort Lauderdale, Florida, United States, 33308
4
University of Miami
Miami, Florida, United States, 33136