Erlotinib vs. Standard Chemotherapy in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) and Eastern Cooperative Oncology Group (ECOG)Performance Status (PS) 2
- Conditions
- Non-Small Cell Lung Cancer
- Interventions
- Registration Number
- NCT00085839
- Lead Sponsor
- OSI Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 103
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Erlotinib Tarceva (Trademark) (erlotinib HCl, OSI-774) Erlotinib tablets administered orally, 150 mg/day (starting dose) or 100 mg/day (reduced dose), continuous therapy Standard Chemotherapy 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
- Primary Outcome Measures
Name Time Method Progression-free Survival Until time of disease progression (maximum 5 months) Median time until disease progression. Disease progression defined as radiological and/or symptomatic disease progression or death in absence of progression.
- Secondary Outcome Measures
Name Time Method Overall Survival From first study treatment until time of death (maximum 26.8 months) Median number of months from first study treatment until time of death
Best Tumor Response While receiving study treatment (maximum 60 weeks) 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.
Trial Locations
- Locations (19)
East Tennessee Oncology/Hematology, PC
🇺🇸Knoxville, Tennessee, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
Thomas Jefferson University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Evanston Northwestern Healthcare
🇺🇸Evanston, Illinois, United States
Mount Sinai Cancer Center
🇺🇸Miami Beach, Florida, United States
Holy Cross Hospital
🇺🇸Fort Lauderdale, Florida, United States
Gabrail Cancer Center
🇺🇸Canton, Ohio, United States
Maryland Hematology/Oncology Associates
🇺🇸Baltimore, Maryland, United States
University Hospitals of Cleveland
🇺🇸Cleveland, Ohio, United States
Oncology/Hematology Associates of Central Illinois
🇺🇸Peoria, Illinois, United States
FEK Addo, PC
🇺🇸Bismarck, North Dakota, United States
Sharp Clinical Oncology Research
🇺🇸San Diego, California, United States
California Cancer Care, Inc.
🇺🇸Greenbrae, California, United States
VA Sierra Nevada Health Care System
🇺🇸Reno, Nevada, United States
Weill Medical College of Cornell University
🇺🇸New York, New York, United States
University of Miami
🇺🇸Miami, Florida, United States
Charleston Hematology Oncology
🇺🇸Charleston, South Carolina, United States
Norton Healthcare, Inc.
🇺🇸Louisville, Kentucky, United States
Sarah Cannon Cancer Center
🇺🇸Nashville, Tennessee, United States