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A Phase II Study of CI-1033 in Treating Patients with Stage IIIB or Stage IV Non-Small Cell Lung Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on A Phase II Study of CI-1033 in Treating Patients with Stage IIIB or Stage IV Non-Small Cell Lung Cancer conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. A Phase II Study of CI-1033 in Treating Patients with Stage IIIB or Stage IV Non-Small Cell Lung Cancer Clinical research trials and A Phase II Study of CI-1033 in Treating Patients with Stage IIIB or Stage IV Non-Small Cell Lung Cancer healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including A Phase II Study of CI-1033 in Treating Patients with Stage IIIB or Stage IV Non-Small Cell Lung Cancer. A Phase II Study of CI-1033 in Treating Patients with Stage IIIB or Stage IV Non-Small Cell Lung Cancer Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a A Phase II Study of CI-1033 in Treating Patients with Stage IIIB or Stage IV Non-Small Cell Lung Cancer clinical trial. Test subjects typically receive the most effective healthcare possible for their A Phase II Study of CI-1033 in Treating Patients with Stage IIIB or Stage IV Non-Small Cell Lung Cancer condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Phase II Study of CI-1033 in Treating Patients with Stage IIIB or Stage IV Non-Small Cell Lung Cancer  A Phase II Study of CI-1033 in Treating Patients with Stage IIIB or Stage IV Non-Small Cell Lung Cancer
A Phase II Study of CI-1033 in Treating Patients with Stage IIIB or Stage IV Non-Small Cell Lung Cancer
For Condition: stage 4 non-small cell lung cancer,Carcinoma, Non-Small Cell Lung,stage 3B non-small cell lung cancer
Status: No longer recruiting
Sponsor(s): Pfizer ,
Synopsis: CI-1033 is an experimental drug that acts as an inhibitor of erbB receptors, which may be involved in tumor growth. The primary objective of this study is to assess the antitumor activity of CI-1033 in patients with progressive or recurrent, locally advanced (Stage IIIb) or metastatic (Stage IV) non-small cell lung cancer. Patients may not have received more than 2 prior cytotoxic chemotherapy regimens and may not have received any prior treatment with other agents that target erbB receptors, such as Iressa (gifitinib). CI-1033 is administered orally. Patients are required to have blood tests periodically while receiving treatment and will be closely monitored throughout the study for possible side effects and response to treatment.
Details:
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: - At least 18 years of age - Histologically or cytologically documented diagnosis of non-small cell lung cancer (NSCLC) - Progressive or recurrent, locally advanced or metastatic NSCLC - Failed or relapsed after receiving a platinum-containing regimen as therapy for advanced NSCLC - At least one measurable target lesion as defined by RECIST that has not been irradiated - Eastern Cooperative Group Performance Status of 0 or 1, determined within 2 weeks prior to randomization - Estimated life expectancy of greater than or equal to 12 weeks - No prior exposure to agents that target the erbB receptor family - Adequate liver, renal, or bone marrow function determined within 2 weeks prior to enrollment [total bilirubin<1.5x the upper limit of normal (ULN), serum ALT or AST<2.5xULN (<5xULN for patients with documented liver metastases), creatinine clearance>30 ml/min, absolute neutrophil count (ANC)>1500/uL or platelets>100,000/uL] - No cytotoxic chemotherapy within 3 weeks prior to baseline disease assessments (6 weeks for nitrosoureas or mitomycin) - No more than 2 prior chemotherapy regimens for treatment of NSCLC, including first-line platinum-containing regimen - No immunotherapy or other biologic therapy within 2 weeks prior to baseline disease assessment - No prior irradiation to areas encompassing greater than 30% of marrow-bearing bone - Must have recovered from the acute effects of prior radiation therapy or surgery - No treatment with any other investigational therapy within 4 weeks prior to baseline disease assessments - No history of any cancer other than the present condition (except nonmelanoma skin cancer or carcinoma in situ of the cervix) within the last 5 years - No patients with untreated brain metastases - No known malabsorption syndrome or other condition that may impair absorption of study medication - No other comorbidity or condition of sufficient severity to limit full compliance with the protocol, or that would significantly complicate interpretation of the safety profile of the study drug - No patients having reproductive potential who are not using an effective method of birth control or who are pregnant or breastfeeding or have a positive pregnancy test during baseline
Total Enrollment: 144
Location and Contact Information:
Ospedale Bellaria
Bologna, , 40139
Italy
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
St Mungo Institute, Glasgow Royal Infirmary
Glasgow, , G4 0SF
United Kingdom
Oncology Specialists, S.C. Lutheran General Cancer Care Center
Park Ridge, Illinois, 60068
United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States
St. Joseph Mercy Hospital
Ann Arbor, Michigan, 48106
United States
Marshfield Clinic
Marshfield, Wisconsin, 54449
United States
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Canada
Asklepios Fachklinik Fuer Lungenkrankheiten
Gauting, , 82131
Germany
Jewish General Hospital
Montreal, Quebec, H3T 1E2
Canada
Ohio State University
Columbus, Ohio, 43210
United States
Guy's Hospital
London, , SE1 9RT
United Kingdom
Mater Misericordiae Hospital
Dublin, ,
Ireland
Norton Healthcare Pavilion, Louisville Oncology
Louisville, Kentucky, 40202
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263
United States
Abteilung Onkologie/ Innere Medizin
Heidelberg, , D-96126
Germany
Institut Català d'Oncologia
Barcelona, , 08907
Spain
H Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
United States
VU Medisch Centrum
Amsterdam, , 1081 HV
Netherlands
The University of Chicago
Chicago, Illinois, 60637
United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Sarah Cannon Cancer Center
Nashville, Tennessee, 37203
United States
Cork University Hospital
Cork, ,
Ireland
Vanderbilt University
Nashville, Tennessee, 37232
United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
United States
Azienda Ospedaliera S. Luigi Gonzaga
Orbassano, Torino, 10043
Italy
University of Alabama
Birmingham, Alabama, 35294
United States
Krankenhaus Grosshansdorf, Zentrum fur Pneumologie
Grosshansdorf, , 22927
Germany
University of Michigan Medical Center
Ann Arbor, Michigan, 48109-0922
United States
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, 60612
United States
Columbia-Presbyterian Medical Center
New York City, New York, 10032
United States
Duke Comprehensive Cancer Center, Duke University
Durham, North Carolina, 27710
United States
Additional Information:
Study ID Numbers: A4161003;
Study Start Date: January 2003
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00050830
Other Stage 3b Non-Small Cell Lung Cancer Studies:
1. Study of EKB-569 in Subjects with Advanced Non-Small Cell Lung Cancer
2. A Phase II Study of CI-1033 in Treating Patients with Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Related Studies:
Other stage 3B non-small cell lung cancer Clinical Trials
Other Pennsylvania Clinical Trials
Other Philadelphia Clinical Trials
A Phase II Study of CI-1033 in Treating Patients with Stage IIIB or Stage IV Non-Small Cell Lung Cancer
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