Status:
COMPLETED
A Study to Evaluate Tarceva in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
Lead Sponsor:
Genentech, Inc.
Conditions:
Lung Cancer
Non-small-cell Lung Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a Phase IIIb, multicenter, open-label trial of daily oral Tarceva in patients with advanced (inoperable Stage IIIb or IV) NSCLC who have progressed following standard chemotherapy treatment.
Eligibility Criteria
Inclusion
- Written (signed) informed consent(s)
- Inoperable and incurable, locally advanced, recurrent or metastatic NSCLC
- Relapse following standard chemotherapy (combination chemotherapy such as two-drug combination chemotherapy, or a single-agent chemotherapy agent for elderly or poor performance status patients)
- Age \>=18 years
- ECOG performance status of 0 to 3
- Recovered from the toxic effects of prior therapy
- Able to comply with study and follow-up procedures
- Able to take oral medication
- Use of an effective means of contraception (for patients with reproductive potential)
- Granulocyte count \>=1.0 x 10\^9/L
- Platelet count \>=75 x 10\^9/L
- Serum bilirubin \<1.5 x upper limit of normal (ULN)
- SGOT (AST) \<2 x ULN unless elevation is clearly due to liver metastases; then SGOT (AST) must be \<5 x ULN
- Serum creatinine \<=1.5 mg/dL
Exclusion
- Any unstable systemic disease (including active infection, unstable angina, congestive heart failure, myocardial infarction within the last 6 months, hepatic, renal, or metabolic disease)
- Prior therapy with any systemic HER1/EGFR small molecule inhibitor, including gefitinib (Iressa), erlotinib (Tarceva), or other investigational agents in this class
- History of another malignancy in the past 2 years unless the malignancy has been adequately treated and is associated with a 5-year anticipated survival of \>=90%
- Known central nervous system (CNS) metastases that have not yet been definitively treated with surgery and/or radiation or that are symptomatic or unstable
- Nursing mothers or pregnant females
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
End Date :
August 1 2005
Estimated Enrollment :
5000 Patients enrolled
Trial Details
Trial ID
NCT00091663
Start Date
August 1 2004
End Date
August 1 2005
Last Update
March 4 2014
Active Locations (92)
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1
Comprehensive Cancer Institute
Huntsville, Alabama, United States, 35801
2
Hematology-Oncology Specialist, Center for Cancer Care
Huntsville, Alabama, United States, 35801
3
Providence Alaska Medical Center
Anchorage, Alaska, United States, 99508
4
Palo Verde Hematology/Oncology, Ltd.
Glendale, Arizona, United States, 85204