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

Condition(s) targeted: Stage IIIB or IV Non-Small Cell Lung Cancer; ECOG Performance Status 2; No Prior Chemotherapy

Intervention: Tarceva (Trademark) (erlotinib HCl, OSI-774) (Drug); Combination carboplatin and paclitaxel (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: OSI Pharmaceuticals

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.

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 design: Interventional, Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Minimum age: 18 Years. Gender(s): Both.

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

Sharp Clinical Oncology Research, San Diego, California 92123, United States

California Cancer Care, Inc., Greenbrae, California 94904, United States

Mount Sinai Cancer Center, Miami Beach, Florida 33140, United States

University of Miami, Miami, Florida 33136, United States

Holy Cross Hospital, Fort Lauderdale, Florida 33308, United States

Oncology/Hematology Associates of Central Illinois, Peoria, Illinois 61615, United States

Evanston Northwestern Healthcare, Evanston, Illinois 60201, United States

Norton Healthcare, Inc., Louisville, Kentucky 40202, United States

Maryland Hematology/Oncology Associates, Baltimore, Maryland 21237, United States

VA Sierra Nevada Health Care System, Reno, Nevada 89502, United States

Weill Medical College of Cornell University, New York, New York 10021, United States

FEK Addo, PC, Bismarck, North Dakota 58503, United States

Gabrail Cancer Center, Canton, Ohio 44718, United States

Ohio State University, Columbus, Ohio 43210-1240, United States

University Hospitals of Cleveland, Cleveland, Ohio 44106, United States

Thomas Jefferson University Hospital, Philadelphia, Pennsylvania 19107, United States

Charleston Hematology Oncology, Charleston, South Carolina 29403, United States

East Tennessee Oncology/Hematology, PC, Knoxville, Tennessee 37920, United States

Sarah Cannon Cancer Center, Nashville, Tennessee 37203, United States

Starting date: February 2004
Last updated: April 13, 2007