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Phase I/II Study of Cetuximab, Gemcitabine, and Carboplatin in Patients With Chemotherapy-Naive Stage IV Non-Small Cell Lung Cancer 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 Phase I/II Study of Cetuximab, Gemcitabine, and Carboplatin in Patients With Chemotherapy-Naive Stage IV Non-Small Cell Lung Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Phase I/II Study of Cetuximab, Gemcitabine, and Carboplatin in Patients With Chemotherapy-Naive Stage IV Non-Small Cell Lung Cancer Clinical research trials and Phase I/II Study of Cetuximab, Gemcitabine, and Carboplatin in Patients With Chemotherapy-Naive Stage IV Non-Small Cell Lung Cancer 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 Phase I/II Study of Cetuximab, Gemcitabine, and Carboplatin in Patients With Chemotherapy-Naive Stage IV Non-Small Cell Lung Cancer. Phase I/II Study of Cetuximab, Gemcitabine, and Carboplatin in Patients With Chemotherapy-Naive Stage IV Non-Small Cell Lung Cancer 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 Phase I/II Study of Cetuximab, Gemcitabine, and Carboplatin in Patients With Chemotherapy-Naive Stage IV Non-Small Cell Lung Cancer clinical trial. Participants frequently obtain the most expert healthcare available for their Phase I/II Study of Cetuximab, Gemcitabine, and Carboplatin in Patients With Chemotherapy-Naive Stage IV Non-Small Cell Lung Cancer 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 > "P" Clinical Trials Conditions > Phase I/II Study of Cetuximab, Gemcitabine, and Carboplatin in Patients With Chemotherapy-Naive Stage IV Non-Small Cell Lung Cancer  Phase I/II Study of Cetuximab, Gemcitabine, and Carboplatin in Patients With Chemotherapy-Naive Stage IV Non-Small Cell Lung Cancer
Phase I/II Study of Cetuximab, Gemcitabine, and Carboplatin in Patients With Chemotherapy-Naive Stage IV Non-Small Cell Lung Cancer
For Condition: stage 4 non-small cell lung cancer,recurrent non-small cell lung cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , UAB Comprehensive Cancer Center
Synopsis: Patient Abstract available in the near future.
Details: OBJECTIVES: I. Determine the safety and toxicity of cetuximab when administered in combination with gemcitabine and carboplatin in patients with chemotherapy-naive stage IV non-small cell lung cancer. II. Determine the response rate and time to progression in patients treated with this regimen. PROTOCOL OUTLINE: This is a multicenter study. Patients receive cetuximab IV over 60-120 minutes on days 1, 8, and 15, and gemcitabine IV over 30 minutes on days 1 and 8 followed by carboplatin IV over 30 minutes on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients who experience unacceptable toxicity to gemcitabine or carboplatin may continue to receive cetuximab alone. Patients are followed at 4 weeks and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 5-7 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed non-small cell lung cancer that is not amenable to potentially curative surgery; Stage IV - Epidermal growth factor receptor expression (1+ or more) by immunohistochemistry - Measurable disease - Chemotherapy-naive - Histologically confirmed recurrent disease allowed after radiotherapy - Meningeal or CNS involvement allowed --Prior/Concurrent Therapy-- - Biologic therapy: No prior cetuximab - Chemotherapy: See Disease Characteristics; No other concurrent chemotherapy - Endocrine therapy: Not specified - Radiotherapy: See Disease Characteristics; At least 4 weeks since prior wide-field radiotherapy (local radiotherapy for management of tumor-related symptoms allowed); No concurrent radiotherapy - Surgery: See Disease Characteristics; At least 30 days since prior major thoracic or abdominal surgery and recovered - Other: At least 30 days since prior investigational agents; At least 4 weeks since any prior therapy and recovered --Patient Characteristics-- - Age: 18 and over - Performance status: Karnofsky 80-100% - Life expectancy: Not specified - Hematopoietic: Absolute neutrophil count at least 1,500/mm3; WBC at least 3,000/mm3; Platelet count at least 100,000/mm3; Hemoglobin at least 9 g/dL - Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN); AST and ALT no greater than 2.5 times ULN; Alkaline phosphatase no greater than 2.5 times ULN - Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min - Cardiovascular: No uncontrolled angina; No arrhythmias; No congestive heart failure - Neurologic: No uncontrolled seizure disorder; No active neurological disease; No neuropathy of grade 2 or greater - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; No other malignancy within the past 3 years except basal cell skin cancer or carcinoma in situ of the cervix
Total Enrollment:
Location and Contact Information:
Overall Study Official:
FranciscoRobert, Study Chair, UAB Comprehensive Cancer Center
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294-3300
United States
Additional Information:
Study ID Numbers: CDR0000069063; UAB-9909,UAB-F010524006,NCI-G01-2030,IMCL-CP02-9925
Study Start Date: October 2001
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00027755
Other Stage 4 Non-Small Cell Lung Cancer Studies:
1. Hospitalization Rates of Patients With Non-Small Cell Lung Cancer Treated With Gemcitabine and Either Cisplatin or Carboplatin
2. Suramin, Paclitaxel, and Carboplatin in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
3. Phase I/II Study of Cetuximab, Gemcitabine, and Carboplatin in Patients With Chemotherapy-Naive Stage IV Non-Small Cell Lung Cancer
4. Suramin and Either Docetaxel or Gemcitabine in Treating Patients With Stage IIIB or Stage IV Platinum-Refractory Non-Small Cell Lung Cancer
5. Paclitaxel and Irinotecan in Treating Patients With Advanced Non-small Cell Lung Cancer
Related Studies:
Other stage 4 non-small cell lung cancer Clinical Trials
Other Alabama Clinical Trials
Other Birmingham Clinical Trials
Phase I/II Study of Cetuximab, Gemcitabine, and Carboplatin in Patients With Chemotherapy-Naive Stage IV Non-Small Cell Lung Cancer
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