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Neoadjuvant Chemoradiotherapy With or Without Gefitinib in Treating Patients With Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Neoadjuvant Chemoradiotherapy With or Without Gefitinib in Treating Patients With Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Neoadjuvant Chemoradiotherapy With or Without Gefitinib in Treating Patients With Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer Clinical research trials and Neoadjuvant Chemoradiotherapy With or Without Gefitinib in Treating Patients With Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Neoadjuvant Chemoradiotherapy With or Without Gefitinib in Treating Patients With Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer. Neoadjuvant Chemoradiotherapy With or Without Gefitinib in Treating Patients With Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Neoadjuvant Chemoradiotherapy With or Without Gefitinib in Treating Patients With Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer clinical trial. Human subjects often get the best healthcare possible for their Neoadjuvant Chemoradiotherapy With or Without Gefitinib in Treating Patients With Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "N" Clinical Trials Conditions > Neoadjuvant Chemoradiotherapy With or Without Gefitinib in Treating Patients With Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer  Neoadjuvant Chemoradiotherapy With or Without Gefitinib in Treating Patients With Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer
Neoadjuvant Chemoradiotherapy With or Without Gefitinib in Treating Patients With Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer
For Condition: stage 3A non-small cell lung cancer,stage 3B non-small cell lung cancer
Status: Recruiting
Sponsor(s): UAB Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of the tumor. Combining chemotherapy and radiation therapy with gefitinib before surgery may shrink the tumor so that it can be removed during surgery. PURPOSE: Phase I/II trial to compare the effectiveness of neoadjuvantchemoradiotherapy with or without gefitinib in treating patients who are undergoing surgery for stage III non-small cell lung cancer.
Details: OBJECTIVES: - Determine the tolerability and toxicity of gefitinib in combination with chest radiotherapy in patients with stage IIIA or stage IIIB non-small cell lung cancer. - Compare the pathologic response (complete response and rate of downstaging) in patients treated with neoadjuvant chemoradiotherapy with vs without gefitinib. - Compare the feasibility and toxicity profile of these regimens in these patients. - Compare the resection rates, time to progression, and overall survival of patients treated with these regimens. - Correlate the percent decline in the fludeoxyglucose F 18 standardized uptake value as measured by position emission tomography with pathologic response at resection, time to progression, and overall survival in patients treated with these regimens. OUTLINE: - This is an open-label, nonrandomized study. - Induction: Patients receive cisplatin IV over 60 minutes on day 1 and gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks for a total of 2 courses in the absence of disease progression or unacceptable toxicity. - Within 3-4 weeks after the completion of induction therapy, patients undergo radiotherapy once daily 5 days a week for 5 weeks and receive oral gefitinib once daily concurrently. A cohort of 3-6 patients receives consolidation chemoradiotherapy. If 2 of 6 patients experience dose-limiting toxicity, gefitinib is deleted from consolidation therapy in phase II arm II. - Surgery: Patients without disease progression after consolidation therapy undergo thoracotomy within 3-5 weeks after consolidation. - Maintenance: Beginning 2-4 weeks after surgery, patients receive oral gefitinib once daily for 6 months in the absence of disease progression. - This is a randomized study. Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive induction and consolidation therapy (with the exception of gefitinib) as in phase I. Patients also receive docetaxel IV over 60 minutes concurrently with radiotherapy during consolidation. Patients undergo surgery as in phase I. - Arm II: Patients receive therapy (including gefinitib) as in phase I. Patients also receive docetaxel IV over 60 minutes concurrently with radiotherapy during consolidation. Patients are followed every 6-8 weeks for the first 12 months and then every 4-6 months thereafter. PROJECTED ACCRUAL: A total of 43-80 patients (3-6 patients for phase I and 40-74 patients [20-37 per treatment arm] for phase II) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 19 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed non-small cell lung cancer - Stage IIIA (T1-3, N2) - Positive (pathological) ipsilateral mediastinal node - Selective stage IIIB meeting all of the following criteria: - No pleural/pericardial effusion or superior vena cava syndrome - T4 due to invasion of carina, trachea, or mediastinal structures - Mediastinal N3 nodes (without supraclavicular or cervical adenopathy) - Proof of N2 or N3 status requires surgical staging of the mediastinum (mediastinoscopy, mediastinotomy, or exploration) - Expression of epidermal growth factor receptor (at least 1+) by immunohistochemistry - Measurable disease by contrast CT scan allowed - No bronchoalveolar cell carcinoma - No prior diagnosis of lung cancer PATIENT CHARACTERISTICS: Age - 19 and over Performance status - ECOG 0-1 (0-2 if albumin is at least 0.85 times lower limit of normal and weight loss within 3 months before diagnosis is no greater than 10%) Life expectancy - Not specified Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 150,000/mm^3 - Hemoglobin at least 10 g/dL Hepatic - Bilirubin normal - AST and ALT no greater than 2.5 times upper limit of normal (ULN) - Alkaline phosphatase no greater than 2 times ULN - Alkaline phosphatase between 1.5-2 times ULN requires a negative bone scan for metastatic bone disease Renal - Creatinine no greater than 1.4 mg/dL OR - Creatinine clearance at least 60 mL/min Cardiac - No myocardial infarction within the past 3 months - No active angina - No unstable heart rhythms - No congestive heart failure Pulmonary - Postresection predicted FEV - % greater than 35% - Predicted FEV_1% is defined as FEV_1% times percent perfusion to uninvolved lung from quantitative lung V/Q scan report Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for at least 6 weeks after study treatment - No other uncontrolled medical illness - No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix - No grade 2 or greater peripheral neuropathy - No concurrent ocular inflammation or infection - No prior severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 - No known severe hypersensitivity reaction to gefinitib or any of its excipients - No prior severe allergic reaction to platinum-containing compounds or mannitol PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent growth factors (e.g., filgrastim [G-CSF] or sargramostim [GM-CSF]) during chemotherapy Chemotherapy - No prior chemotherapy for lung cancer Endocrine therapy - Not specified Radiotherapy - No prior radiotherapy for lung cancer Surgery - Recovered from prior major surgery - No concurrent opthalmic surgery Other - More than 30 days since prior unapproved or investigational drugs - No concurrent use of the following drugs: - Phenytoin - Carbamazepine - Barbiturates - Rifampin - Phenobarbital - Hypericum perforatum (St. John's Wort) - Warfarin - No concurrent retinoids
Total Enrollment:
Location and Contact Information:
Overall Study Official:
FranciscoRobert, Study Chair, UAB Comprehensive Cancer Center
University of Alabama at Birmingham Comprehensive Cancer Center *Recruiting*
Birmingham, Alabama, 35294-3300
United States
Recruiting Francisco Robert 205-934-5077
Additional Information:
Study ID Numbers: CDR0000304674; UAB-F020730006,ZENECA-ZD1839US-0207,AVENTIS-GIA-12139,UAB-0162
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00062270
Other Stage 3a Non-Small Cell Lung Cancer Studies:
1. Combination Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
2. Combination Chemotherapy in Treating Patients With Advanced Non-Small Cell Lung Cancer
3. Radiation Therapy in Treating Patients With Non-small Cell Lung Cancer
4. Soblidotin in Treating Patients With Progressive Locally Advanced or Metastatic Non-Small Cell Lung Cancer
5. Combination Chemotherapy, Surgery, and Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer
Related Studies:
Other stage 3A non-small cell lung cancer Clinical Trials
Other Alabama Clinical Trials
Other Birmingham Clinical Trials
Neoadjuvant Chemoradiotherapy With or Without Gefitinib in Treating Patients With Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer
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