OSI-774 (Tarceva) in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

Condition(s) targeted: Carcinoma, Non-Small-Cell Lung

Intervention: Tarceva (erlotinib HCl, OSI-774 ) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: OSI Pharmaceuticals

Official(s) and/or principal investigator(s):
Frances Shepherd, M.D., Study Chair

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).

Official title: 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

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Hospital Interzonal de Agudos Evita, Buenos Aires B1824, Argentina

Hospital Churruca Visca, Buenos Aires C1427, Argentina

Hospital Britanico, Buenos Aires 1280, Argentina

Instituto Oncologico Angel Roffo, Capital Federal CP1417, Argentina

Instituto Alexander fleming, Buenos Aires C1426ANZ, Argentina

Hospital Italiano, Capital Federal, Argentina

Royal Adelaide Hospital, South Australia 5000, Australia

Peter MacCallum Cancer Institute, Victoria 3002, Australia

Austin & Repatriation Medical Centre, Victoria 3084, Australia

Institution: Clinica Las Condes, Santiago, Chile

Pamela Youde Nethersole Easter Hospital, Hong Kong, China

Queen Mary Hospital, Hong Kong, China

Thoraxklinik Heidelberg, Heidelberg 69126, Germany

Zentrum fur pheulmologie und Thoraxchirurgie, Grosshansdorf 22927, Germany

Lungenklinik Hermer, Hermer 58675, Germany

Asklepios Fachkiniken, Gauting 82131, Germany

Lungenklinik Heckeshorn, Berlin 14109, Germany

Sotiria Hospital, Athens 115 27, Greece

Kaplan Medical Center, Rehovot, Israel

Haemek Medical Center, Afula 18101, Israel

RAMBAM Medical Center, Haifa, Israel

Rabin Medical Center Beilinson Campus, Petach-Tiqva 49100, Israel

Rabin Medical Center Golda Campus, Petach-Tiqva 49372, Israel

Sheba Medical Center Oncology Day Care, Tel Hashomer 52621, Israel

Sourasky Medical Center Oncology Institute, Tel Aviv 64239, Israel

Assaf Harofeh Medical Center, Zerifin 70300, Israel

Hospital Central Sur de Alta Especialidad, PEMEX, Mexico City, Mexico

Centro Estatal de Cancerologia de Durango, Durango, Mexico

Greenlane Hospital - New Zealand, Auckland 3, New Zealand

Oncology Institute Bucharest, Bucharest, Romania

Clinical County Hospital, Sibiu 2400, Romania

Oncology Institute Ion Chiricuta, Cluj Napoca 3400, Romania

Spitalul Universitar, Iasi 6600, Romania

National Cancer Centre - Singapore, Singapore 169610, Singapore

National University Hospital, Singapore 119074, Singapore

Johannesburg Hospital, Parktown 2193, South Africa

Rosebank Clinic Oncology Unit, Rosebank, South Africa

Oncotherapy Dept, National Hospital, Bloemfontein 9301, South Africa

Eastern Cape Oncology Centre, Port Elizabeth 6000, South Africa

Mary Potter Oncology Centre, Pretoria, South Africa

University of Pretoria, Pretoria, South Africa

Sandton Oncology Centre, Parklands 2121, South Africa

Sahlgrenska University Hospital, Lund, Sweden

Lund University Hospital, Lund, Sweden

Chiangmai University, Chiangmai 50002, Thailand

Div. of Med Onc. The National Cancer Institute of Thailand, Bangkok 10400, Thailand

Cross Cancer Institute, Edmonton, Alberta T6G 1Z2, Canada

Tom Baker Cancer Centre, Calgary, Alberta T2N 4N2, Canada

Canberra Hospital- Australia, Woden, Australian Capital Territory 2605, Australia

Nucleo de Oncologia da Bahia, Salvador, Bahia 40170-070, Brazil

Pramongkutklao Hospital, Phayathai, Bangkok 10400, Thailand

Cancer Centre for the Southern Interior, Kelowna, British Columbia V1Y 5L3, Canada

BCCA - Vancouver Island, Victoria, British Columbia V8R 6V5, Canada

Instituto Nacional de Cancerologia, Rio de Janeiro, CEP 20230-130, Brazil

Instituto do Cancer do Ceara, Fortaleza, CEP 60430-230, Brazil

Centro Medico Confidence, Buenos Aires, CP 1642, Argentina

Instituto Nacional de Cancerologia, Mexico City, CP 14000, Mexico

Durban Oncology Centre, Westbridge, Durban 4091, South Africa

University of Chicago Medical Center, Chicago, Illinois 60637, United States

CancerCare Manitoba (CCMB), Winnipeg, Manitoba R3E 0V9, Canada

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

Dr.H. Bliss Murphy Cancer Centre, St. John's, Newfoundland and Labrador A1B 3V6, Canada

QEII Health Sciences Centre, Halifax, Nova Scotia B3H 2Y9, Canada

Hotel Dieu Health Sciences Hospital, St. Catherines, Ontario L2R 5K3, Canada

Group Health Centre, Sault St. Marie, Ontario P6A 2C4, Canada

The Royal Victoria Hospital, Barrie, Ontario L4M 6M2, Canada

Southlake Regional Health Centre, Newmarket, Ontario L3Y 2P9, Canada

Toronto East General Hospital, Toronto, Ontario M4C 3E7, Canada

Princess Margaret Hospital, Toronto, Ontario M5G 2M9, Canada

Toronto-Sunnybrook Reg.Canc.Center, Toronto, Ontario M4N 3M5, Canada

Peterborough Regional Health Centre, Peterborough, Ontario K9H 7B6, Canada

Northeastern Ontario Regional Cancer Centre, Sudbury, Ontario P3E 5J1, Canada

Mount Sinai Hospital, Toronto, Ontario M5G 1X5, Canada

Hamilton Regional Cancer Centre, Hamilton, Ontario L9V 5C2, Canada

Kingston Regional Cancer Centre, Kingston, Ontario K7L 5P9, Canada

Ottawa Regional Cancer Centre, Ottawa, Ontario K1H 1C4, Canada

Credit Valley Hospital, Missisauga, Ontario L5M 2N1, Canada

Humbar River Regional Hospital, Weston, Ontario M9N 1N8, Canada

Die Wilgers Hospital, Lynnwood, Pretoria, South Africa

Hopital Laval, Ste Foy, Quebec G1V 4G5, Canada

Hopital Notre-Dame du CHUM, Montreal, Quebec H2L 4M1, Canada

Hopital Du Sacre - Coeur De Montreal, Montreal, Quebec H4J 1C5, Canada

McGill University, Montreal, Quebec H2W 1S6, Canada

Hospital Sao Lucas da PUCRS, Porto Alegre, RS CEP 90610-000, Brazil

Irmandade Santa Casa de Miseicordia de Porto, Porto Alegre, RS CEP 90020-090, Brazil

Instituto do Cancer Arnaldo Vieira de Carvalho, Sao Paulo, SP 01224-010, Brazil

Faculdade de Medicina do ABC, Santo Andre, SP CEP 09060-650, Brazil

Escola Paulista de Medicina, Sao Paulo, SP CEP 040039-032, Brazil

Allan Blair Cancer Centre, Regina, Saskatchewan S4T 7T1, Canada

The Royal Melbourne Hospital, Parkville, Victoria 3050, Australia

Western Hospital, Footscray, Victoria 3011, Australia

University of Washington, Seattle, Washington 98109, United States

Wellington Hospital, Riddiford Street, Wellington, New Zealand

Sir Charles Gairdner Hospital, Nedlands, Western Australia 6009, Australia

Hospital Vera Cruz S/A, Belo Horizonte, mg CEP 30190-130, Brazil

Starting date: October 2001
Ending date: January 2003
Last updated: December 16, 2005