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Erlotinib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Erlotinib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Erlotinib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer Clinical research trials and Erlotinib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Erlotinib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer. Erlotinib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Erlotinib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer clinical trial. Participants oftentimes recieve the most expert healthcare available for their Erlotinib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "E" Clinical Trials Conditions > Erlotinib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer  Erlotinib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Erlotinib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
For Condition: stage 3B non-small cell lung cancer,recurrent non-small cell lung cancer,stage 4 non-small cell lung cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute of Canada ,
Synopsis: RATIONALE: Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor. It is not yet known whether erlotinib is effective in treating advanced or metastatic non-small cell lung cancer. PURPOSE: Randomized phase III trial to determine the effectiveness of erlotinib in treating patients who have stage IIIB or stage IV non-small cell lung cancer that has not responded to previous treatment.
Details: OBJECTIVES: - Compare the effect of erlotinib vs placebo on the overall and progression-free survival of patients with incurable stage IIIB or IV non-small cell lung cancer that is refractory to standard therapy. - Compare the response rates and response duration in patients treated with these regimens. - Compare the nature, severity, and frequency of toxic effects in patients treated with these regimens. - Compare the quality of life of patients treated with these regimens. - Correlate the expression of tissue epidermal growth factor receptor levels at diagnosis with outcomes and response in patients treated with erlotinib. - Correlate trough levels of this drug with clinical response and/or adverse events in these patients. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to participating center, ECOG performance status (0-1 vs 2-3), best response to prior therapy (complete or partial response vs stable disease vs progressive disease), number of prior regimens (1 vs 2), and prior exposure to platinum (yes vs no). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive oral erlotinib once daily. - Arm II: Patients receive oral placebo once daily. Treatment in both arms continues until disease progression or unacceptable toxicity. Quality of life is assessed at baseline, every 4 weeks during treatment, 4 weeks after the completion of treatment, and then every 12 weeks thereafter. Patients are followed at 4 weeks and then every 12 weeks thereafter. PROJECTED ACCRUAL: A total of 330 patients (220 in arm I and 110 in arm II) will be accrued for this study within 20 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed incurable stage IIIB or IV non-small cell lung cancer - Refractory to at least 1, but no more than 2, prior combination chemotherapy regimens - Elderly (70 years of age and over) patients may have received 1 or 2 prior single-agent regimens - Measurable lesions (if present) that are the sole site of disease must be outside a prior radiotherapy field, unless disease progression has been documented at that site - CNS metastases allowed if asymptomatic and receiving stable dose of corticosteroids for at least the past 4 weeks PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-3 Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Bilirubin less than 1.5 times upper limit of normal (ULN) - ALT less than 2 times ULN (5 times ULN if clearly due to liver metastases) Renal: - Creatinine less than 1.5 times ULN Cardiovascular: - No uncontrolled hypertension - No unstable angina - No congestive heart failure - No myocardial infarction within the past year - No cardiac ventricular arrhythmias requiring medication Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - HIV negative - No prior allergic reactions to compounds of similar chemical or biologic composition to erlotinib - No untreated ocular inflammation or infection - No clinically significant ophthalmologic abnormalities, including: - Severe dry eye syndrome - Keratoconjunctivitis sicca - Sjogren's syndrome - Severe exposure keratopathy - No disorders that might increase risk for epithelium-related complications (e.g., bullous keratopathy, aniridia, severe chemical burns, or neutrophilic keratitis) - No clinically significant gastrointestinal abnormalities including uncontrolled inflammatory disease (e.g., Crohn's or ulcerative colitis) - No other serious underlying medical condition that would preclude study - No psychological or geographical condition that would preclude study - No serious active infection - No history of breast cancer or melanoma at any time - No other prior malignancy within the past 5 years except carcinoma in situ or basal or squamous cell skin cancer - Other prior malignancies allowed if cured by surgery alone and continuously disease free for at least 5 years PRIOR CONCURRENT THERAPY: Biologic therapy: - No concurrent anticancer biologic or immunotherapy Chemotherapy: - See Disease Characteristics - At least 21 days since prior chemotherapy (14 days for vinorelbine or other vinca alkaloids or gemcitabine) and recovered - No concurrent palliative cytotoxic chemotherapy Endocrine therapy: - See Disease Characteristics Radiotherapy: - See Disease Characteristics - At least 7 days since prior radiotherapy and recovered - No concurrent anticancer full dose radiotherapy - Concurrent low-dose, non-myelosuppressive, palliative radiotherapy allowed Surgery: - At least 2 weeks since prior major surgery - No concurrent ophthalmic surgery Other: - No prior epidermal growth factor receptor inhibitor therapy of any kind - No other concurrent anticancer cytotoxic therapy - No concurrent non-anticancer investigational drugs during study and for at least 30 days after final dose of study drug
Total Enrollment:
Location and Contact Information:
Overall Study Official:
FrancesShepherd, Study Chair, Princess Margaret Hospital
Hospital Britanico
Buenos Aires, , 1280
Argentina
Royal Melbourne Hospital
Parkville, Victoria, 3050
Australia
Peter MacCallum Cancer Institute
East Melbourne, Victoria, 3002
Australia
Eastern Cape Oncology Centre
Port Elizabeth, , 6059
South Africa
University of Washington Medical Center
Seattle, Washington, 98109-1023
United States
Ottawa Regional Cancer Centre
Ottawa, Ontario, K1H 1C4
Canada
Ramathiabodi Hospital
Bangkok, , 10400
Thailand
Peterborough Oncology Clinic
Peterborough, Ontario, K9H 7B6
Canada
Northeastern Ontario Regional Cancer Centre, Sudbury
Sudbury, Ontario, P3E 5J1
Canada
Hopital Du Sacre-Coeur de Montreal
Montreal, Quebec, H4J 1C5
Canada
Hospital Italiano
Buenos Aires, , CP1181ACH
Argentina
Instituto de Cancer Arnaldo Vieira de Carvalho
Sao Paulo, , 01224-010
Brazil
Assaf Harofeh Medical Center
Zerifin, , 70300
Israel
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Australia
Hospital Sao Lucas da Pucros
Porto Alegre, , 90610-000
Brazil
Nucleo de Oncologia da Bahia
Bahia, , 40170-070
Brazil
Instituto de Cancer de Ceara
Ceara, , 60430-230
Brazil
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1
Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Canada
District General Hospital of Chest Disease of Athens
ATHENS, , 11527
Greece
University of Chicago Cancer Research Center
Chicago, Illinois, 60637
United States
Southlake Regional Health Centre
Newmarket, Ontario, L3Y 2P9
Canada
Lund University Hospital
Lund, , S-22185
Sweden
Sydney Children's Hospital
Randwick, New South Wales, 2031
Australia
L'Hopital Laval
Ste Foy, Quebec, G1V 4G5
Canada
Wilgers Oncology Centre
Pretona, , 0001
South Africa
McGill University
Montreal, Quebec, H2W 1S6
Canada
Kingston Regional Cancer Centre
Kingston, Ontario, K7L 5P9
Canada
Escola Paulista de Medicina
Sao Paulo, , CEP-1509
Brazil
Rambam Medical Center
Haifa, , 31096
Israel
British Columbia Cancer Agency - Vancouver Island Cancer Centre
Victoria, British Columbia, V8R 6V5
Canada
Thoraxklinik Rohrbach
Heidelberg, , D-69126
Germany
Medical Oncology Centre of Rosebank
Johannesburg, , 2193
South Africa
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, M4N 3M5
Canada
Austin and Repatriation Medical Centre
Heidelberg West, Victoria, 3081
Australia
Newfoundland Cancer Treatment and Research Foundation
St. Johns, Newfoundland and Labrador, A1B 3V6
Canada
Nova Scotia Cancer Centre
Halifax, Nova Scotia, B3H 1V7
Canada
Hospital Vera Cruz S/A Instituto de Oncologia
Belo Horizonte, Minas Gerais, 30190-130
Brazil
Confidence Medical Center
San Isidro, , 1642
Argentina
University of Witwatersrand Faculty of Health Sciences
Johannesburg, , 2193
South Africa
Tel-Aviv Sourasky Medical Center
Tel Aviv, , 64239
Israel
Centro Estatal de Cancerologia
Dviango, , 34000
Mexico
Canberra Hospital
Garran, , 2605
Australia
Hospital Interzonal De Augudos Euita
Lanus, , 1824
Argentina
Queen Mary Hospital
Hong Kong, ,
China
Mary Potter Oncology Centre
Brooklyn Square, , 1577
South Africa
Green Lane Hospital
Auckland, , 3
New Zealand
National Cancer Centre - Singapore
Singapore, , 169610
Singapore
Sandton Oncology Centre
Johannesburg, , 2121
South Africa
Wellington Cancer Centre
Wellington, , 6039
New Zealand
Institutul Oncologic-Universitatea de Medicina
Cluj Napoca, , 3400
Romania
Instituto de Oncologia Angel H. Roffo
Buenos Aires, , 1417
Argentina
Durban Oncology Centre
Westridge, , 4091
South Africa
Rabin Medical Center
Petah-Tikva, , 49372
Israel
Hospital Santa Rita Irtmandade Santa Casa De Porto Alegre
Porto Alegre, , 91330-490
Brazil
Hospital Churruca
Buenos Aires, , 1437
Argentina
Toronto General Hospital
Toronto, Ontario, M5G 2C4
Canada
Royal Victoria Hospital, Barrie
Barrie, Ontario, L4M 6M2
Canada
Pretoria Academic Hospital
Pretoria, , 0001
South Africa
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9
Canada
Clinica Las Condes
Santiago, ,
Chile
Sir Charles Gairdner Hospital, Perth
Perth, Western Australia, 6009
Australia
Southern Medical Day Care Centre
Wollongong, New South Wales, 2500
Australia
Hospital Central Sur de Alta
Mexico City, Distrito Federal, 04091
Mexico
Kaplan Hospital
Rehovot, , 76100
Israel
Credit Valley Hospital
Mississauga, Ontario, L5M 2N1
Canada
British Columbia Cancer Agency - Centre for the Southern Interior
Kelowna, British Columbia, V1Y 5L3
Canada
Mount Sinai Hospital - Toronto
Toronto, Ontario, M5G 1X5
Canada
Humber River Regional Hospital
Weston, Ontario, M9N 1N8
Canada
Lungenklink Heckeshom
Berlin, , 14109
Germany
Instituto Nac de Cancerologia
Tlalpan, Distrito Federal, 22
Mexico
Lungenklinik Hemer
Hemer, , D-58675
Germany
Toronto East General Hospital
Toronto, Ontario, M4C 3E7
Canada
National Hospital
Bloemfontein, , 9300
South Africa
Asklepios Fachkliniken Munchen - Gauting
Munich, , DOH-82131
Germany
Algoma District Medical Group
Sault Sainte Marie, Ontario, P6B 1Y5
Canada
Tom Baker Cancer Center - Calgary
Calgary, Alberta, T2N 4N2
Canada
Chiangmai University
Chiangmai, , 50200
Thailand
Instituto Nacional de Cancer
Rio de Janeiro, , 20230-130
Brazil
Hopital Notre- Dame du CHUM
Montreal, Quebec, H4L 2M1
Canada
National University Hospital
Singapore, , 119074
Singapore
Cancer Care Ontario-Hamilton Regional Cancer Centre
Hamilton, Ontario, L8V 5C2
Canada
Phramongkutklao Hospital
Bangkok, , 10400
Thailand
Sahlgrenska University Hospital
Gothenburg (Goteborg), , S-413 45
Sweden
Hotel Dieu Health Sciences Hospital - Niagara
St. Catharines, Ontario, L2R 5K3
Canada
Additional Information:
Study ID Numbers: CDR0000069019; CAN-NCIC-BR21,OSI-CAN-NCIC-BR21
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00026325
Other Recurrent Non-Small Cell Lung Cancer Studies:
1. Suramin, Paclitaxel, and Carboplatin in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
2. Bortezomib With or Without Docetaxel in Treating Patients With Relapsed or Refractory Advanced Non-Small Cell Lung Cancer
3. Carboxyamidotriazole in Treating Patients With Stage III or Stage IV Non-small Cell Lung Cancer
4. Phase I/II Study of Cetuximab, Gemcitabine, and Carboplatin in Patients With Chemotherapy-Naive Stage IV Non-Small Cell Lung Cancer
5. Combination Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
Related Studies:
Other recurrent non-small cell lung cancer Clinical Trials
Other Ontario Clinical Trials
Other Newmarket Clinical Trials
Erlotinib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
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