Erlotinib (Tarceva) vs. Standard Chemotherapy (Paclitaxel and Carboplatin) in Patients With Advanced NSCLC and ECOG PS 2 - Full Text View

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

Purpose

The purpose of this study is to obtain preliminary estimates of the efficacy of erlotinib and standard chemotherapy in patients with advanced, previously untreated NSCLC and an ECOG PS of 2. The study will also evaluate the safety of single-agent erlotnib 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:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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:

Preliminary estimates of the magnitude and variability of the efficacy of erlotinib and standard chemotherapy in terms of median progression-free survival, Evaluate the safety [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Tumor response, Duration of response, Overall survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	102
Study Start Date:	February 2004
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Erlotinib tablets administered PO, 150 mg/day (starting dose) or 100 mg/day (reduced dose), continuous therapy	Drug: Tarceva (Trademark) (erlotinib HCl, OSI-774) Erlotinib tablets administered PO, 150 mg/day (starting dose) or 100 mg/day (reduced dose), continuous therapy
2: Active Comparator Paclitaxel 200 mg/m2 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/m2 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 NSCLC
No prior chemotherapy
ECOG Performance Status 2
Clinically or radiologically measurable disease per RECIST criteria

Exclusion Criteria:

Gastro-intestinal abnormalities
Any concurrent anticancer therapy
Prior treatment with 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
Sharp Clinical Oncology Research
San Diego, California, United States, 92123
California Cancer Care, Inc.
Greenbrae, California, United States, 94904
United States, Florida
Mount Sinai Cancer Center
Miami Beach, Florida, United States, 33140
University of Miami
Miami, Florida, United States, 33136
Holy Cross Hospital
Fort Lauderdale, Florida, United States, 33308
United States, Illinois
Oncology/Hematology Associates of Central Illinois
Peoria, Illinois, United States, 61615
Evanston Northwestern Healthcare
Evanston, Illinois, United States, 60201
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
Ohio State University
Columbus, Ohio, United States, 43210-1240
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
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

No publications provided

Responsible Party:	OSI Pharmaceuticals, Inc. ( Angela Davies, MD )
Study ID Numbers:	OSI-774-201, Tarceva Performance Status 2
Study First Received:	June 15, 2004
Last Updated:	November 3, 2009
ClinicalTrials.gov Identifier:	NCT00085839 History of Changes
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:

Erlotinib
Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Enzyme Inhibitors
Antimitotic Agents
Carboplatin
Protein Kinase Inhibitors
Pharmacologic Actions

Carcinoma
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Paclitaxel
Therapeutic Uses
Lung Diseases
Tubulin Modulators
Antineoplastic Agents, Phytogenic
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2009