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Genetic Changes in Patients With Non-Small Cell Lung Cancer Who Are Receiving Vinorelbine and Gemcitabine Before Surgery 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 Genetic Changes in Patients With Non-Small Cell Lung Cancer Who Are Receiving Vinorelbine and Gemcitabine Before Surgery conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Genetic Changes in Patients With Non-Small Cell Lung Cancer Who Are Receiving Vinorelbine and Gemcitabine Before Surgery Clinical research trials and Genetic Changes in Patients With Non-Small Cell Lung Cancer Who Are Receiving Vinorelbine and Gemcitabine Before Surgery 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 Genetic Changes in Patients With Non-Small Cell Lung Cancer Who Are Receiving Vinorelbine and Gemcitabine Before Surgery. Genetic Changes in Patients With Non-Small Cell Lung Cancer Who Are Receiving Vinorelbine and Gemcitabine Before Surgery 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 Genetic Changes in Patients With Non-Small Cell Lung Cancer Who Are Receiving Vinorelbine and Gemcitabine Before Surgery clinical trial. Test subjects typically receive the most effective healthcare possible for their Genetic Changes in Patients With Non-Small Cell Lung Cancer Who Are Receiving Vinorelbine and Gemcitabine Before Surgery 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 > "G" Clinical Trials Conditions > Genetic Changes in Patients With Non-Small Cell Lung Cancer Who Are Receiving Vinorelbine and Gemcitabine Before Surgery  Genetic Changes in Patients With Non-Small Cell Lung Cancer Who Are Receiving Vinorelbine and Gemcitabine Before Surgery
Genetic Changes in Patients With Non-Small Cell Lung Cancer Who Are Receiving Vinorelbine and Gemcitabine Before Surgery
For Condition: stage 3B non-small cell lung cancer,stage 2 non-small cell lung cancer,stage 3A non-small cell lung cancer,stage 1 non-small cell lung cancer
Status: No longer recruiting
Sponsor(s): Roswell Park Cancer Institute , National Cancer Institute (NCI)
Synopsis: RATIONALE: Determination of genetic changes in patients with non-small cell lung cancer may help predict the outcome of treatment. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug, and giving them before surgery, may shrink the tumor so that it can be removed during surgery. PURPOSE: Phase II trial to study genetic changes and the effectiveness of combining vinorelbine with gemcitabine before surgery in treating patients who have stage IB, stage II, or stage III non-small cell lung cancer.
Details: OBJECTIVES: - Determine the frequency of expression of epithelial markers CK19, CK20, MUC1, and MUC5 (by reverse transcriptase-polymerase chain reaction) in lymph node tissue and blood samples of patients with resectable stage IB-III non-small cell lung cancer treated with neoadjuvant vinorelbine and gemcitabine followed by surgery. - Determine the expression of the multidrug resistance-associated protein gene before and after treatment with this regimen in these patients. - Determine the global expression profile of genes (by microarray technology) in tumor tissue of patients treated with this regimen. - Determine the frequency of loss of heterozygosity at several loci on chromosomes 3p, 9p, and 11p before and after treatment with this regimen in these patients. - Determine the percent positivity of cells that stain for MCM2 and CDC6 (prereplicative complex) by immunohistochemistry before and after treatment with this regimen in these patients. - Determine the feasibility of this regimen in these patients. - Determine the pathological response rates in patients treated with this regimen. - Determine the side effects of this regimen in these patients. - Determine the disease-free and overall survival of patients treated with this regimen. - Determine the autologous immune response in patients treated with this regimen. OUTLINE: Patients receive vinorelbine IV over 6-10 minutes and gemcitabine IV over 30 minutes on days 1, 8, 22, and 29 in the absence of disease progression or unacceptable toxicity. Patients with no disease progression by scans or bronchoscopy undergo surgical resection between days 57-70 (weeks 8-10). Loss of heterozygosity (LOH) at loci on chromosomes 3p, 9p, and 11p is assessed in blood specimens, tumor tissue, and noncancerous tissue before and after chemotherapy. Specimens are also examined for molecular markers of occult metastasis using reverse transcriptase-polymerase chain reaction. Multidrug resistance-associated protein gene expression is also determined using microarray technology. Patients are followed every 3 months for 2 years, every 6 months for 5 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed non-small cell carcinoma of the lung - May be confirmed at the initial bronchoscopy and mediastinoscopy - Stage IB (T2, N0, M0) - Stage IIA (T1, N1, M0) - Stage IIB (T2-3, N0-1, M0) - Stage IIIA (T1-3, N1-2, M0) - stage IIIB (2 lesions in 1 lobe [T4]) - No N3 lymph nodes (contralateral mediastinal/hilar and supraclavicular/scaline) OR T4 primary tumor (malignant pleural effusion or mediastinal invasion) by clinical staging criteria (seen on CT or PET scan and proven by mediastinoscopy) - No metastatic disease (except N1 or N2 disease) or malignant pleural effusion* detected on preoperative evaluation - No exudative effusions (even if cytologically negative) - Pleural fluid is considered exudative if the following apply: - Ratio of pleural fluid protein to serum protein is greater than 0.5 - Ratio of pleural fluid lactic dehydrogenase (LDH) to serum LDH is at least 0.6 - Pleural fluid LDH is greater than 200 IU/L - No multiple areas of fluorodeoxyglucose (FDG) uptake** outside the area of the primary tumor in the lung NOTE: *Effusions visible only on CT scan and not large enough for safe thoracentesis are allowed NOTE: **If only 1 area shows an increase in FDG uptake, the area of concern requires further evaluation (e.g., biopsy) to exclude metastatic disease - Bidimensionally measurable or evaluable disease* NOTE: *Lesions apparent on chest CT scan (e.g., ill-defined masses associated with post obstructive changes and mediastinal or hilar adenopathy measurable in 1 dimension) are considered evaluable PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Not specified Life expectancy - Not specified Hematopoietic - WBC at least 3,000/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 9 g/dL Hepatic - Bilirubin no greater than 1.5 mg/dL - AST or ALT no greater than 1.5 times upper limit of normal Renal - Creatinine no greater than 1.5 mg/dL Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - Deemed medically fit for surgical resection - No other active malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of the cervix - No psychological, sociological, or geographical condition that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy - Concurrent participation in the RPCI vaccine study (postoperative vaccination with autologous tumor-associated antigen-pulsed dendritic cells) is allowed Chemotherapy - No prior chemotherapy for lung cancer - No concurrent participation in another study involving other chemotherapy agents Endocrine therapy - Not specified Radiotherapy - No prior radiotherapy for lung cancer - No concurrent participation in another study involving radiotherapy Surgery - No prior surgery for lung cancer - More than 3 months since other prior major surgery (e.g., coronary artery bypass graft) Other - No other prior therapy for lung cancer - No other concurrent antineoplastic agents - Concurrent participation in observational studies requiring bloodwork, radiographs, pulmonary function tests, or quality of life studies is allowed
Total Enrollment:
Location and Contact Information:
Overall Study Official:
NithyaRamnath, Study Chair, Roswell Park Cancer Institute
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
Additional Information:
Study ID Numbers: CDR0000270753; RPCI-RP-00-01
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00057798
Other Stage 3a Non-Small Cell Lung Cancer Studies:
1. Positron Emission Tomography for Detecting Non-small Cell Lung Cancer
2. Detection of Early Metastases in Patients With Stage I Non-small Cell Lung Cancer
3. Chemotherapy Plus Radiation Therapy in Treating Patients With Stage I, Stage II, or Stage III Non-small Cell Lung Cancer That Cannot Be Surgically Removed
4. Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer
5. Megestrol in Treating Patients Who Are Undergoing Radiation Therapy for Lung Cancer
Related Studies:
Other stage 3A non-small cell lung cancer Clinical Trials
Other New York Clinical Trials
Other Buffalo Clinical Trials
Genetic Changes in Patients With Non-Small Cell Lung Cancer Who Are Receiving Vinorelbine and Gemcitabine Before Surgery
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