The purpose of this study is to determine if OSI-774 will improve overall survival of patients with incurable stage IIIB/IV non-small cell lung cancer compared to standard of care. OSI-774 is a new type of drug under evaluation called an epidermal growth factor receptor (EGFR). OSI-774 is an investigational drug that has not yet been approved by the U.S. Food and Drug Administration (FDA).
A Randomized Placebo Controlled Study of OSI-744 (Erlotinib HCl, Tarceva[TM]) in Patients With Incurable Stage IIIB/IV Non-Small Cell Lung Cancer Who Have Failed Standard Therapy for Advanced or Metastatic Disease
Non-Small-Cell Lung Carcinoma
Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
October 2001; Study completion: January 2003
Eligibility & Criteria
- Ages Eligible for Study: 18 Years and above
- Genders Eligible for Study: Both
- Clinical diagnosis of stage IIIB or IV non-small cell lung cancer.
- Must have evidence of disease (clinical or radiological).
- Have failed 1 but no more than 2 prior chemotherapy regimens, have recovered from any side effects and have not had any chemotherapy for at least 21 days.
- If the patient has had surgery, the surgery was at least 2 weeks ago.
- Patients whose cancer has spread to their brain or central nervous system are eligible, providing that they have been on stable dose of steroids for at least 4 weeks and are free of symptoms.
- If the patient received radiation therapy, treatment was at least 4 weeks ago.
Australian Locations:Australian Capital Territory
- Canberra Hospital- Australia, Woden, Australian Capital Territory, 2605, Australia
New South Wales
- Newcastle Mater Misericordiae Hospital, Waratah, New South Wales, 2289, Australia
- Prince of Wales Hospital, Randwick, New South Wales, 2031, Australia
- Southern Medical Day Care Center, Wollongong, New South Wales, 2500, Australia
- Royal Adelaide Hospital, South Australia, 5000, Australia
- The Royal Melbourne Hospital, Parkville, Victoria, 3050, Australia
- Western Hospital, Footscray, Victoria, 3011, Australia
- Austin & Repatriation Medical Centre, Victoria, 3084, Australia
- Peter MacCallum Cancer Institute, Victoria, 3002, Australia
- Sir Charles Gairdner Hospital, Nedlands, Western Australia, 6009, Australia
Contact OSI Pharmaceuticals
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