Erlotinib vs. Standard Chemotherapy in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) and Eastern Cooperative Oncology Group (ECOG)Performance Status (PS) 2 - Full Text View

Sponsor:	OSI Pharmaceuticals
Information provided by:	OSI Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00085839

Purpose

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.

Condition	Intervention	Phase
Non-Small Cell Lung Cancer	Drug: Tarceva (Trademark) (erlotinib HCl, OSI-774) Drug: Combination carboplatin and paclitaxel	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Paclitaxel Carboplatin Erlotinib hydrochloride Erlotinib

U.S. FDA Resources

Further study details as provided by OSI Pharmaceuticals:

Primary Outcome Measures:

Progression-free Survival [ Time Frame: Until time of disease progression (maximum 5 months) ] [ Designated as safety issue: No ]
Median time until disease progression. Disease progression defined as radiological and/or symptomatic disease progression or death in absence of progression.

Secondary Outcome Measures:

Overall Survival [ Time Frame: From first study treatment until time of death (maximum 26.8 months) ] [ Designated as safety issue: No ]
Median number of months from first study treatment until time of death
Best Tumor Response [ Time Frame: While receiving study treatment (maximum 60 weeks) ] [ Designated as safety issue: No ]
Change in size of tumor: Complete Response (CR) = no measurable tumor; Partial Response (PR) = 30% decrease in size of measurable tumor; Stable Disease (SD) = measurable tumor size has not changed; Progressive Disease (PD) = measurable tumor 20% larger than at baseline.

Enrollment:	103
Study Start Date:	February 2004
Study Completion Date:	March 2007
Primary Completion Date:	March 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Erlotinib Erlotinib tablets administered orally, 150 mg/day (starting dose) or 100 mg/day (reduced dose), continuous therapy	Drug: Tarceva (Trademark) (erlotinib HCl, OSI-774) Erlotinib tablets administered orally, 150 mg/day (starting dose) or 100 mg/day (reduced dose), continuous therapy
Active Comparator: Standard Chemotherapy Paclitaxel 200 mg/m^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 - 30 minutes, both given on Day 1 every 21 days for 4 cycles	Drug: Combination carboplatin and paclitaxel Paclitaxel 200 mg/m^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 - 30 minutes, both given on Day 1 every 21 days for 4 cycles

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00085839

Locations

United States, California
California Cancer Care, Inc.
Greenbrae, California, United States, 94904
Sharp Clinical Oncology Research
San Diego, California, United States, 92123
United States, Florida
Holy Cross Hospital
Fort Lauderdale, Florida, United States, 33308
University of Miami
Miami, Florida, United States, 33136
Mount Sinai Cancer Center
Miami Beach, Florida, United States, 33140
United States, Illinois
Evanston Northwestern Healthcare
Evanston, Illinois, United States, 60201
Oncology/Hematology Associates of Central Illinois
Peoria, Illinois, United States, 61615
United States, Kentucky
Norton Healthcare, Inc.
Louisville, Kentucky, United States, 40202
United States, Maryland
Maryland Hematology/Oncology Associates
Baltimore, Maryland, United States, 21237
United States, Nevada
VA Sierra Nevada Health Care System
Reno, Nevada, United States, 89502
United States, New York
Weill Medical College of Cornell University
New York, New York, United States, 10021
United States, North Dakota
FEK Addo, PC
Bismarck, North Dakota, United States, 58503
United States, Ohio
Gabrail Cancer Center
Canton, Ohio, United States, 44718
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
Ohio State University
Columbus, Ohio, United States, 43210-1240
United States, Pennsylvania
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
Charleston Hematology Oncology
Charleston, South Carolina, United States, 29403
United States, Tennessee
East Tennessee Oncology/Hematology, PC
Knoxville, Tennessee, United States, 37920
Sarah Cannon Cancer Center
Nashville, Tennessee, United States, 37203

Sponsors and Collaborators

OSI Pharmaceuticals

More Information

Additional Information:

OSI Pharmaceuticals website This link exits the ClinicalTrials.gov site

Link to Prescribing Information This link exits the ClinicalTrials.gov site

Publications:

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.

Responsible Party:	Clinical Trials Registry, Astellas Pharma Global Development
ClinicalTrials.gov Identifier:	NCT00085839 History of Changes
Other Study ID Numbers:	OSI-774-201
Study First Received:	June 15, 2004
Results First Received:	March 28, 2011
Last Updated:	June 30, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by OSI Pharmaceuticals:

Tarceva
NSCLC
EGFR
ECOG Performance Status 2

erlotinib
Non-Small Cell Lung Cancer
OSI-774

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carboplatin
Paclitaxel

Erlotinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Protein Kinase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on February 13, 2012