Clinical trial NCT00085839: Erlotinib vs. Standard Chemotherapy in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) and Eastern Cooperative Oncology Group (ECOG)Performance Status (PS) 2
Official title: A Randomized Phase II Study of Single Agent Erlotinib [Tarceva (TM), OSI-774] Versus Standard Chemotherapy in Patients With Previously Untreated Advanced NSCLC and a Poor Performance Status
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer
Keywords: Tarceva
NSCLC
EGFR
ECOG Performance Status 2
erlotinib
Non-Small Cell Lung Cancer
OSI-774
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2004-06-17
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 cancer (NSCLC) and an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 2. The study will also evaluate the safety of single-agent erlotinib in this patient population.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Progression-free Survival
timeFrame: Until time of disease progression (maximum 5 months)
Secondary outcomes:
measure: Overall Survival
timeFrame: From first study treatment until time of death (maximum 26.8 months)
measure: Best Tumor Response
timeFrame: While receiving study treatment (maximum 60 weeks)
Other outcomes:
Locations:
city: Greenbrae
country: United States
facility: California Cancer Care, Inc.
state: California
city: San Diego
country: United States
facility: Sharp Clinical Oncology Research
state: California
city: Fort Lauderdale
country: United States
facility: Holy Cross Hospital
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Cancer Center
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Evanston
country: United States
facility: Evanston Northwestern Healthcare
state: Illinois
city: Peoria
country: United States
facility: Oncology/Hematology Associates of Central Illinois
state: Illinois
city: Louisville
country: United States
facility: Norton Healthcare, Inc.
state: Kentucky
city: Baltimore
country: United States
facility: Maryland Hematology/Oncology Associates
state: Maryland
city: Reno
country: United States
facility: VA Sierra Nevada Health Care System
state: Nevada
city: New York
country: United States
facility: Weill Medical College of Cornell University
state: New York
city: Bismarck
country: United States
facility: FEK Addo, PC
state: North Dakota
city: Canton
country: United States
facility: Gabrail Cancer Center
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: Charleston Hematology Oncology
state: South Carolina
city: Knoxville
country: United States
facility: East Tennessee Oncology/Hematology, PC
state: Tennessee
city: Nashville
country: United States
facility: Sarah Cannon Cancer Center
state: Tennessee
Study officials:
References:
citation: Lilenbaum R, Axelrod R, Thomas S, Dowlati A, Seigel L, Albert D, Witt K, Botkin D. Randomized phase II trial of erlotinib or standard chemotherapy in patients with advanced non-small-cell lung cancer and a performance status of 2. J Clin Oncol. 2008 Feb 20;26(6):863-9. doi: 10.1200/JCO.2007.13.2720.