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Home > "T" Clinical Trials Conditions > Tarceva Surgery for Resectable Stage IIIA(N2) Non-Small-Cell Lung Cancer  Tarceva Surgery for Resectable Stage IIIA(N2) Non-Small-Cell Lung Cancer
Tarceva Surgery for Resectable Stage IIIA(N2) Non-Small-Cell Lung Cancer
For Condition: Non-small cell lung cancer
Status: Recruiting
Sponsor(s): M.D. Anderson Cancer Center ,
Synopsis: The goal of this clinical research study is to learn about the safety and effectiveness of OSI-774 when combined with standard chemotherapy (carboplatin and paclitaxel) before surgery in the treatment of non-small cell lung cancer.
Details: This is a phase II, single institution open label randomized trial of induction carboplatin and paclitaxel plus/minus daily oral OSI-774 in patients with resectable IIIA/N2 NSCLC. Patients will be required to have pathologically demonstrated N2 disease via mediastinoscopy. Forty patients will be treated with 3 courses of chemotherapy followed by surgery. Ten of these patients will be randomized to chemotherapy alone and 30 patients to chemotherapy plus OSI-774. The 10 patients will serve as a chemotherapy alone control for molecular endpoint analysis. OSI-774 will be stopped the night before surgery. At the time of surgery, pathologic response will be determined. Following surgery, all 40 patients will be treated with consolidation radiation therapy as a single modality. This will be followed by maintenance OSI-774 for patients from both arms of the study. OSI-774 will be continued as maintenance to a maximum of 2 years following surgery. Tissue for molecular studies will be obtained pretreatment either at the time of diagnostic biopsy or mediastinoscopy. Post-treatment tissue will be obtained at the time of surgery. This tissue will be assayed for defined molecular endpoints using immunohistochemistry, immunoprecipitation and mRNA expression analysis. Blood, urine, hair follicles, and skin samples will also be collected from patients who consent to provide these.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: - Must have signed consent for LAB03-0383 - Pathologic documentation of NSCLC - Stage IIIA, mediastinoscopy positive N2, potentially resectable disease - Measurable disease - Zubrod performance status of 0 or 1 - Calculated post-resectional FEV1 of > 40% - No prior chemotherapy or radiation for NSCLC - No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the patient has been disease-free for at least five years. - WBC>4000/ul, ANC>1500/ul, platelets > 100,000/ul - Serum creatinine < 1.5 ULN or calculated creatinine > 50 cc/min - Total serum bilirubin <1.5 x ULN and SGPT or SGOT < 2 X ULN - No post-obstructive pneumonia or other serious infection or other serious underlying medical condition that would impair ability of patient to receive protocol treatment, including prior allergic reactions to drugs containing cremophor. - Pregnant or nursing women may not participate
Total Enrollment: 40
Location and Contact Information:
MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030
United States
Recruiting Ralph Zinner 713-792-6363
Additional Information:
Study ID Numbers: ID02-327;
Study Start Date: June 2003
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00063258
Other Non-Small Cell Lung Cancer Studies:
1. Combination Chemotherapy Plus Thalidomide in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
2. Combination Chemotherapy in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer
3. Selenium in Preventing Tumor Growth in Patients With Previously Resected Stage I Non-small Cell Lung Cancer
4. Gefitinib in Treating Patients With Non-Small Cell Lung Cancer That Has Been Surgically Removed
5. Chest X-ray or Chest CT Scan in Patients at High Risk of Developing Lung Cancer
Related Studies:
Other Non-small cell lung cancer Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Tarceva Surgery for Resectable Stage IIIA(N2) Non-Small-Cell Lung Cancer
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