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Gefitinib in Treating Patients With Non-Small Cell Lung Cancer That Has Been Surgically Removed Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Gefitinib in Treating Patients With Non-Small Cell Lung Cancer That Has Been Surgically Removed conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Gefitinib in Treating Patients With Non-Small Cell Lung Cancer That Has Been Surgically Removed Clinical research trials and Gefitinib in Treating Patients With Non-Small Cell Lung Cancer That Has Been Surgically Removed medical trials happen in hundreds of localities 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 measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Gefitinib in Treating Patients With Non-Small Cell Lung Cancer That Has Been Surgically Removed. Gefitinib in Treating Patients With Non-Small Cell Lung Cancer That Has Been Surgically Removed Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Gefitinib in Treating Patients With Non-Small Cell Lung Cancer That Has Been Surgically Removed clinical trial. Participants frequently obtain the most expert healthcare available for their Gefitinib in Treating Patients With Non-Small Cell Lung Cancer That Has Been Surgically Removed condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "G" Clinical Trials Conditions > Gefitinib in Treating Patients With Non-Small Cell Lung Cancer That Has Been Surgically Removed  Gefitinib in Treating Patients With Non-Small Cell Lung Cancer That Has Been Surgically Removed
Gefitinib in Treating Patients With Non-Small Cell Lung Cancer That Has Been Surgically Removed
For Condition: Non-small cell lung cancer
Status: Recruiting
Sponsor(s): National Cancer Institute of Canada , National Cancer Institute (NCI),Eastern Cooperative Oncology Group,Southwest Oncology Group
Synopsis: RATIONALE: Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of the tumor. It is not yet known if gefitinib is effective in delaying the recurrence of non-small cell lung cancer. PURPOSE: Randomizedphase III trial to study the effectiveness of gefitinib in treating patients who have undergone surgery for stage IB, stage II, or stage IIIA non-small cell lung cancer.
Details: OBJECTIVES: - Compare the overall survival of patients with completely resected primary stage IB, II, or IIIA non-small cell lung cancer treated with gefitinib vs placebo. - Compare the disease-free survival of patients treated with these regimens. - Determine the prognostic significance of epidermal growth factor receptor expression, phosphorylation, and mutations in the primary tumor in predicting relative impact of gefitinib on survival of these patients. - Determine the toxicity of gefitinib in these patients. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to disease stage (IB vs II vs IIIA), histological subtype (squamous cell vs others), postoperative radiotherapy (yes vs no), prior adjuvant platinum-based chemotherapy (yes vs no), and gender. Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive oral gefitinib daily. - Arm II: Patients receive oral placebo daily. Treatment in both arms continues for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 6 months, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 1,242 patients (621 per treatment arm) will be accrued for this study within 3.5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed primary non-small cell lung cancer (NSCLC) - Bronchoalveolar carcinoma presenting as discrete solitary radiological mass or nodule allowed - Stage IB, II, or IIIA disease - Completely resected by lobectomy, sleeve resection, bilobectomy, or pneumonectomy within the past 16 weeks (26 weeks for patients who received adjuvant platinum-based chemotherapy) - Mediastinal lymph node resection or lymph node sampling attempted with no evidence of metastatic involvement - No combination of small cell and non-small cell carcinoma or pulmonary carcinoid tumor - No more than 1 discrete area of apparent primary cancer (even within the same lobe) PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - WBC at least 3,000/mm^3 - Absolute granulocyte count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin normal - AST/ALT no greater than 2.5 times upper limit of normal (ULN) - Alkaline phosphatase no greater than 2.5 times ULN Renal - Creatinine no greater than 1.5 times ULN Cardiovascular - No uncontrolled congestive heart failure - No angina - No arrhythmias Other - No active uncontrolled infection - No clinically significant or untreated ophthalmologic conditions (e.g., Sjögren's syndrome) - No clinically significant or untreated gastrointestinal conditions (e.g., Crohn's disease or ulcerative colitis) - No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or carcinoma in situ of the cervix - No other concurrent malignancy - No prior allergic reaction to compounds of similar chemical or biological composition to gefitinib - No history of psychiatric or neurologic disorder that would preclude study compliance - No active pathological condition that would preclude study participation - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 3 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy - No prior or concurrent neoadjuvant or adjuvant immunotherapy for NSCLC Chemotherapy - See Disease Characteristics - At least 3 weeks since prior adjuvant platinum-based chemotherapy for NSCLC and recovered - No prior non-platinum-based chemotherapy - No other prior or concurrent neoadjuvant or adjuvant chemotherapy for NSCLC Endocrine therapy - Not specified Radiotherapy - Prior preoperative limited-field, low-dose external beam radiotherapy (less than 1,000 cGy) or endobronchial brachytherapy allowed - At least 3 weeks since prior radiotherapy and recovered - No prior full-dose preoperative radiotherapy with curative intent Surgery - See Disease Characteristics - Recovered from prior oncologic or other major surgery Other - Prior laser therapy for short-term control of hemoptysis or lobar obstruction allowed - No other concurrent anticancer therapy - No concurrent drugs that induce CYP3A4 enzymes (e.g., phenytoin, carbamazepine, barbiturates, rifampin, or Hypericum perforatum [St. John's wort])
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PeterRoberts, Study Chair, University of California Davis Cancer Center
L'Hotel Dieu de Levis *Recruiting*
Levis, Quebec, G6V 3Z1
Canada
Recruiting Felix Couture 418-691-5225
Kingston Regional Cancer Centre *Recruiting*
Kingston, Ontario, K7L 5P9
Canada
Recruiting Kenneth Reid 613-548-2383
New York Weill Cornell Cancer Center at Cornell University *Recruiting*
New York City, New York, 10021
United States
Recruiting Nasser Altorki 212-746-4528
Ottawa Regional Cancer Centre *Recruiting*
Ottawa, Ontario, K1H 1C4
Canada
Recruiting Glenwood Goss 613-737-7700 ext. 56758
Westmead Hospital *Recruiting*
Westmead, New South Wales, 2145
Australia
Recruiting Richard Kefford 61-2-9845-6033
Veterans Affairs Medical Center - Chicago (Westside Hospital) *Recruiting*
Chicago, Illinois, 60612
United States
Recruiting Thomas Lad 312-996-2046
Veterans Affairs Medical Center - Biloxi *Recruiting*
Biloxi, Mississippi, 39531-2410
United States
Recruiting Robert Veith 504-568-5151
Iowa Lutheran Hospital *Recruiting*
Des Moines, Iowa, 50316-2301
United States
Recruiting Roscoe Morton 515-663-5612
Hopital Charles Lemoyne *Recruiting*
Greenfield Park, Quebec, J4V 2H1
Canada
Recruiting Pierre Desjardins 450-466-5065
Hotel Dieu Health Sciences Hospital - Niagara *Recruiting*
St. Catharines, Ontario, L2R 5K3
Canada
Recruiting Brian Findlay 905-682-6451
CCOP - St. Vincent Hospital Cancer Center, Green Bay *Recruiting*
Green Bay, Wisconsin, 54307-3453
United States
Recruiting Gerald Bayer 920-433-8889
Trillium Health Centre *Recruiting*
Mississauga, Ontario, L5B 1B8
Canada
Recruiting John Gapski 905-848-7160
Mercy Cancer Center at Mercy Medical Center-Des Moines *Recruiting*
Des Moines, Iowa, 50314
United States
Recruiting Roscoe Morton 515-247-3121
University of California Davis Cancer Center *Recruiting*
Sacramento, California, 95817-2280
United States
Recruiting Peter Roberts 916-734-3861
James P. Wilmot Cancer Center at University of Rochester Medical Center *Recruiting*
Rochester, New York, 14642
United States
Recruiting Richard Fisher 585-275-0842
MBCCOP - University of New Mexico HSC *Recruiting*
Albuquerque, New Mexico, 87131
United States
Recruiting Cynthia Cathcart 505-272-5688
Instituto de Enfermedades Neoplasicas *Recruiting*
Lima, , 34
Peru
Recruiting Carlos Vallejos-Sologuren 51-14-499-137
Medical City Dallas Hospital *Recruiting*
Dallas, Texas, 75230
United States
Recruiting Mark Capistrano 972-566-5588
University of Tennessee Cancer Institute *Recruiting*
Memphis, Tennessee, 38103
United States
Recruiting Mohammad Jahanzeb 901-722-0532
Hollings Cancer Center at Medical University of South Carolina *Recruiting*
Charleston, South Carolina, 29425
United States
Recruiting Carolyn Reed 843-792-3362
Penn State Cancer Institute at Milton S. Hershey Medical Center *Recruiting*
Hershey, Pennsylvania, 17033-0850
United States
Recruiting Witold Rybka 717-531-1050
Cross Cancer Institute *Recruiting*
Edmonton, Alberta, T6G 1Z2
Canada
Recruiting Timothy Winton 780-407-3624
Prince Edward Island Cancer Center at Queen Elizabeth Hospital *Recruiting*
Charlottetown, Prince Edward Island, C1A 8T5
Canada
Recruiting Philip Champion 902-894-2027
MBCCOP - Hawaii *Recruiting*
Honolulu, Hawaii, 96813
United States
Recruiting Brian Issell 808-586-3013
Durham Regional Cancer Centre at Lakeridge Health Oshawa *Recruiting*
Oshawa, Ontario, L1G 2B9
Canada
Recruiting Rafal Wierzbicki 905-576-8711 ext. 4044
Saint John Regional Hospital *Recruiting*
Saint John, New Brunswick, E2L 4L2
Canada
Recruiting Margot Burnell 506-648-6884
John Stoddard Cancer Center at Iowa Methodist Medical Center *Recruiting*
Des Moines, Iowa, 50309
United States
Recruiting Roscoe Morton 515-241-4245
Midlands Cancer Center at Midlands Community Hospital *Recruiting*
Papillion, Nebraska, 68128-4157
United States
Recruiting James Mailliard 402-593-3000
MBCCOP - Massey Cancer Center *Recruiting*
Richmond, Virginia, 23298-0037
United States
Recruiting John Roberts 804-828-0450
Toronto Sunnybrook Regional Cancer Centre *Recruiting*
Toronto, Ontario, M4N 3M5
Canada
Recruiting Yee Ung 416-480-4951
Harrington Cancer Center *Recruiting*
Amarillo, Texas, 79106
United States
Recruiting James Clarkson 806-359-4673
Princess Margaret Hospital *Recruiting*
Toronto, Ontario, M5G 2M9
Canada
Recruiting Gail Darling 416-340-3121
MetroHealth Medical Center *Recruiting*
Cleveland, Ohio, 44109
United States
Recruiting Edward Mansour 216-778-4394
Northwestern Ontario Regional Cancer Care *Recruiting*
Thunder Bay, Ontario, P7B 6V4
Canada
Recruiting Adrien Chan 807-684-7200
Veterans Affairs Medical Center - Charleston *Recruiting*
Charleston, South Carolina, 29401-5799
United States
Recruiting Andrew Turrisi 843-792-273
Northeastern Ontario Regional Cancer Centre - Sudbury *Recruiting*
Sudbury, Ontario, P3E 5J1
Canada
Recruiting Jonathan Noble 705-522-6237 ext. 2320
Allan Blair Cancer Centre *Recruiting*
Regina, Saskatchewan, S4T 7T1
Canada
Recruiting Haji Chalchal 306-766-2691
Fletcher Allen Health Care - University Health Center Campus *Recruiting*
Burlington, Vermont, 05401
United States
Recruiting Steven Grunberg 802-847-8400
San Juan City Hospital *Recruiting*
San Juan, , 00936-7344
Puerto Rico
Recruiting Luis Baez-Diaz 787-641-3693
St. Joseph's Health Centre - Toronto *Recruiting*
Toronto, Ontario, M6R 1B5
Canada
Recruiting John Blondal 416-530-6586
Robert H. Lurie Comprehensive Cancer Center at Northwestern University *Recruiting*
Chicago, Illinois, 60611-3013
United States
Recruiting Gregory Masters 312-908-5250
Additional Information:
Study ID Numbers: CDR0000258118; SWOG-CAN-NCIC-BR19,CAN-NCIC-BR19,CTSU,ECOG-CAN-NCIC-BR19
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00049543
Other Non-Small Cell Lung Cancer Studies:
1. Phase II Study of Taxotere in Combination with Exisulind in Non-Small Cell Lung Cancer (NSCLC) Patients
2. Evaluation of efficacy, safety and tolerability of Targretin capsules in patients with advanced or metastatic non-small cell lung cancer
3. Helical Computed Tomography Compared With Chest X-Ray in Screening Individuals at High Risk for Lung Cancer
4. Computed Tomography for Early Detection of Cancer in Women Who Are at Risk for Lung Cancer
5. Oral Investigational Drug Vs. Approved Intravenous Treatment In Pretreated, Advanced Non-Small Cell Lung Cancer (NSCLC).
Related Studies:
Other Non-small cell lung cancer Clinical Trials
Other New South Wales Clinical Trials
Other Westmead Clinical Trials
Gefitinib in Treating Patients With Non-Small Cell Lung Cancer That Has Been Surgically Removed
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