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Trastuzumab in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer That Overexpresses HER2 Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Trastuzumab in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer That Overexpresses HER2 conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Trastuzumab in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer That Overexpresses HER2 Clinical research trials and Trastuzumab in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer That Overexpresses HER2 healthcare trials happen in many 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 drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Trastuzumab in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer That Overexpresses HER2. Trastuzumab in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer That Overexpresses HER2 Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Trastuzumab in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer That Overexpresses HER2 clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Trastuzumab in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer That Overexpresses HER2 condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "T" Clinical Trials Conditions > Trastuzumab in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer That Overexpresses HER2  Trastuzumab in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer That Overexpresses HER2
Trastuzumab in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer That Overexpresses HER2
For Condition: recurrent non-small cell lung cancer,stage 4 non-small cell lung cancer,stage 3B non-small cell lung cancer
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , Cancer and Leukemia Group B
Synopsis: RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase II trial to study the effectiveness of trastuzumab in treating patients who have stage IIIB or stage IV non-small cell lung cancer that overexpresses HER2.
Details: OBJECTIVES: OBJECTIVES: I. Determine the activity of trastuzumab (Herceptin) in patients with stage IIIB or IV HER2-overexpressing non-small cell lung cancer. II. Determine the duration of response in patients treated with this regimen. III. Determine the toxicity of this treatment regimen in this patient population. IV. Assess levels of circulating HER2 and correlate with HER2 expression in this patient population. PROTOCOL OUTLINE: Patients are stratified according to prior treatment (yes vs no). Patients receive trastuzumab (Herceptin) IV over 30-90 minutes on day 1. Treatment continues once a week in the absence of disease progression or unacceptable toxicity. Patients are followed every 8 weeks until disease progression or death. PROJECTED ACCRUAL: Approximately 84 patients (42 per stratum) will be accrued for this study within 17.5 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed stage IIIB or IV non-small cell lung cancer; Supraclavicular node involvement allowed; Malignant pleural effusion allowed (cytological confirmation not required if pleural fluid bloody or exudative) - No stage IIIB patients eligible for CLB protocols comprising combined chemotherapy and chest radiotherapy - Recurrent disease allowed - HER2 overexpression (2-3+) - At least 1 unidimensionally measurable lesion; At least 20 mm by conventional techniques OR At least 10 mm by spiral CT scan The following are not considered measurable: Bone lesions; Leptomeningeal disease; Ascites; Pleural/pericardial effusion; Abdominal masses not confirmed and followed by imaging; Cystic lesions - No CNS metastases --Prior/Concurrent Therapy-- - Biologic therapy: No prior murine antibodies - Chemotherapy: See Disease Characteristics; No prior anthracyclines; No more than 1 prior chemotherapy regimen for lung cancer; At least 4 weeks since prior chemotherapy; No concurrent chemotherapy - Endocrine therapy: No concurrent steroids except for adrenal failure or dexamethasone as an antiemetic; No concurrent hormonal therapy except for nondisease-related conditions (e.g., insulin for diabetes) - Radiotherapy: See Disease Characteristics; At least 6 months since prior radiotherapy; No concurrent palliative radiotherapy - Surgery: At least 4 weeks since prior major surgery --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-2 - Life expectancy: Not specified - Hematopoietic: Granulocyte count at least 1,500/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) - Renal: Creatinine no greater than 1.5 times ULN - Cardiovascular: LVEF at least 45% (by echocardiogram or MUGA) - Other: Not pregnant or nursing; Fertile patients must use effective contraception; HIV negative; No concurrent immunologic disease (e.g., autoimmune disease); No history of allergy to murine products
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GeraldClamon, Study Chair, Cancer and Leukemia Group B
Veterans Affairs Medical Center - Birmingham
Birmingham, Alabama, 35233-1996
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1082
United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94143-0128
United States
Holden Comprehensive Cancer Center at The University of Iowa
Iowa City, Iowa, 52242-1009
United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756-0002
United States
Green Mountain Oncology Group
Bennington, Vermont, 05201
United States
State University of New York - Upstate Medical University
Syracuse, New York, 13210
United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, 65201
United States
CCOP - Christiana Care Health Services
Wilmington, Delaware, 19899
United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203
United States
Veterans Affairs Medical Center - Memphis
Memphis, Tennessee, 38104
United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, 55417
United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
CCOP - Mount Sinai Medical Center
Miami, Florida, 33140
United States
Hematology Oncology Associates of the Quad Cities
Bettendorf, Iowa, 52722
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Mount Sinai Medical Center, NY
New York City, New York, 10029
United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, 13217
United States
Veterans Affairs Medical Center - White River Junction
White River Junction, Vermont, 05009
United States
Veterans Affairs Medical Center - Togus
Togus, Maine, 04330
United States
Rhode Island Hospital
Providence, Rhode Island, 02903
United States
CCOP - Southeast Cancer Control Consortium
Winston Salem, North Carolina, 27104-4241
United States
New York Presbyterian Hospital - Cornell Campus
New York City, New York, 10021
United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
United States
Veterans Affairs Medical Center - Durham
Durham, North Carolina, 27705
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
University of Tennessee, Memphis Cancer Center
Memphis, Tennessee, 38103
United States
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, 13210
United States
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, 14215
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
United States
Schneider Children's Hospital at North Shore
Manhasset, New York, 11030
United States
University of California San Diego Cancer Center
La Jolla, California, 92093-0658
United States
Lombardi Cancer Center
Washington D.C., District of Columbia, 20007
United States
Veterans Affairs Medical Center - San Francisco
San Francisco, California, 94121
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-3330
United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Veterans Affairs Medical Center - Richmond
Richmond, Virginia, 23249
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
Barnes-Jewish Hospital
St. Louis, Missouri, 63110
United States
MBCCOP - Massey Cancer Center
Richmond, Virginia, 23298-0037
United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655
United States
CCOP - North Shore University Hospital
Manhasset, New York, 11030
United States
Vermont Cancer Center
Burlington, Vermont, 05401-3498
United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, 60612
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Additional Information:
Study ID Numbers: CDR0000067555; CLB-39810
Study Start Date: February 2000
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004883
Other Stage 3b Non-Small Cell Lung Cancer Studies:
1. Vaccine Therapy in Treating Patients With Stage IIIB or Stage IV Bronchoalveolar Lung Cancer
2. Combination Chemotherapy in Treating Patients With Advanced Non-Small Cell Lung Cancer
3. Vaccine Therapy With or Without Low-Dose Cyclophosphamide in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
4. Polyglutamate Paclitaxel Compared With Gemcitabine or Vinorelbine in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
5. SGN-15 And Docetaxel in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
Related Studies:
Other stage 3B non-small cell lung cancer Clinical Trials
Other North Carolina Clinical Trials
Other Winston Salem Clinical Trials
Trastuzumab in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer That Overexpresses HER2
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