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Cetuximab, Paclitaxel, Carboplatin, and Radiation Therapy in Treating Patients With Unresectable Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Cetuximab, Paclitaxel, Carboplatin, and Radiation Therapy in Treating Patients With Unresectable Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Cetuximab, Paclitaxel, Carboplatin, and Radiation Therapy in Treating Patients With Unresectable Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer Clinical research trials and Cetuximab, Paclitaxel, Carboplatin, and Radiation Therapy in Treating Patients With Unresectable Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Cetuximab, Paclitaxel, Carboplatin, and Radiation Therapy in Treating Patients With Unresectable Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer. Cetuximab, Paclitaxel, Carboplatin, and Radiation Therapy in Treating Patients With Unresectable Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Cetuximab, Paclitaxel, Carboplatin, and Radiation Therapy in Treating Patients With Unresectable Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer clinical trial. Human subjects often receive the most effective healthcare possible for their Cetuximab, Paclitaxel, Carboplatin, and Radiation Therapy in Treating Patients With Unresectable Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Cetuximab, Paclitaxel, Carboplatin, and Radiation Therapy in Treating Patients With Unresectable Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer  Cetuximab, Paclitaxel, Carboplatin, and Radiation Therapy in Treating Patients With Unresectable Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer
Cetuximab, Paclitaxel, Carboplatin, and Radiation Therapy in Treating Patients With Unresectable Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer
For Condition: bronchoalveolar cell lung cancer,stage 3A non-small cell lung cancer,squamous cell lung cancer,adenocarcinoma of the lung,large cell lung cancer,stage 3B non-small cell lung cancer
Status: Recruiting
Sponsor(s): Radiation Therapy Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Monoclonal antibodies, such as cetuximab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in 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. Combining cetuximab with combination chemotherapy and radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining cetuximab with paclitaxel, carboplatin, and radiation therapy in treating patients who have unresectablestage IIIA or stage IIIB non-small cell lung cancer.
Details: OBJECTIVES: Primary - Determine the feasibility of cetuximab when administered concurrently with paclitaxel, carboplatin, and radiotherapy, in terms of safety and compliance, in patients with unresectable stage IIIA or IIIB non-small cell lung cancer. Secondary - Determine the response rate (complete and partial) in patients treated with this regimen. - Determine the overall survival (1- and 2-year survival rate and median survival) of patients treated with this regimen. - Determine the time to disease progression (at 1 and 2 years) in patients treated with this regimen. - Correlate epidermal growth factor receptor expression with the toxicity of this regimen and response, overall survival, and progression in these patients. OUTLINE: This is a multicenter study. - Cetuximab loading dose (week 1): Patients receive a loading dose of cetuximab IV over 2 hours on day 1. - Concurrent cetuximab and chemoradiotherapy (weeks 2-8): Patients receive cetuximab IV over 1 hour, paclitaxel IV over 1 hour, and carboplatin IV over 30 minutes on days 8, 15, 22, 29, 36, 43, and 50. Patients undergo radiotherapy once daily on days 8-12, 15-19, 22-26, 29-33, 36-40, 43-47, and 50-53. - Consolidation therapy (weeks 9-17): Patients receive cetuximab IV over 1 hour on days 57, 64, 71, 78, 85, 92, 99, 106, and 113. Patients also receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on days 78 and 99. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed at 30 days, every 3 months for 2 years, and then every 4 months for 2 years. PROJECTED ACCRUAL: A total of 84 patients will be accrued for this study within 1 year.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) of 1 of the following subtypes: - Squamous cell carcinoma - Adenocarcinoma (including bronchoalveolar cell) - Large cell anaplastic carcinoma (including giant and clear cell carcinomas) - Poorly differentiated/not otherwise specified NSCLC - Stage IIIA (T1-2, N2, M0 or T3, N1-2, M0) or IIIB (T4, any N, M0 or any T, N2-3, M0) - If the largest mediastinal node is < 2.0 cm in diameter and this is the basis for stage III disease, then at least 1 of the nodes must be cytologically or histologically positive - Unresectable disease - No totally resected tumors - Tumors adjacent to a vertebral body allowed provided all gross disease can be encompassed in the radiation boost field and the boost volume is limited to < 50% of the ipsilateral lung volume - Measurable disease - Transudate, cytologically negative, non-bloody pleural effusions allowed provided the tumor can be encompassed within a reasonable field of radiotherapy - Pleural effusions seen on a chest CT scan are allowed provided they are not visible on a chest x-ray and are too small to tap - No asymptomatic or symptomatic brain metastases PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Zubrod 0-1 Life expectancy - Not specified Hematopoietic - Absolute neutrophil count 1,500/mm^3 - Platelet count 100,000/mm^3 - Hemoglobin 9 g/dL (transfusion independent) Hepatic - Bilirubin 1.5 mg/dL - SGOT or SGPT 3 times upper limit of normal (ULN) - Alkaline phosphatase 2.5 times ULN Renal - Creatinine 2.0 mg/dL Cardiovascular - No significant history of cardiac disease - No uncontrolled hypertension - No unstable angina - No uncompensated congestive heart failure - No myocardial infarction within the past year - No cardiac ventricular arrhythmias requiring medication - LVEF normal by MUGA or echocardiogram Pulmonary - No history of interstitial pneumonitis - No history of severe chronic obstructive pulmonary disease requiring 3 or more hospitalizations within the past year - FEV_1 1,200 cc - No active pulmonary infection unresponsive to conventional antibiotics Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 4 weeks after study therapy - Glucose 2 times ULN - No more than 5% weight loss within the past 3 months - No known allergy to murine proteins or Cremophor EL - No neuropathy grade 2 or greater - No other malignancy within the past 2 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or other in situ cancers PRIOR CONCURRENT THERAPY: Biologic therapy - No prior drugs that target the epidermal growth factor receptor pathway - No prior chimerized monoclonal antibody therapy - No other concurrent immunotherapy - No concurrent colony-stimulating factors (i.e., filgrastim [G-CSF] and sargramostim [GM-CSF]) - Concurrent epoetin alfa allowed Chemotherapy - No prior systemic chemotherapy - No other concurrent chemotherapy Endocrine therapy - No concurrent hormonal therapy except hormones for non-disease-related conditions (e.g., insulin for diabetes) or steroids for acute symptom management, adrenal failure, septic shock, or as antiemetics Radiotherapy - No prior thoracic or neck radiotherapy - No concurrent intensity-modulated radiotherapy Surgery - Recovered from prior exploratory thoracotomy - No prior surgical resection of the present cancer Other - No other concurrent anticancer therapy - No amifostine during or for 3 months after study radiotherapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GeorgeBlumenschein, Study Chair, M.D. Anderson Cancer Center
Arlington Cancer Center *Recruiting*
Arlington, Texas, 76012
United States
Recruiting Charles Lee 817-261-4906
Additional Information:
Study ID Numbers: CDR0000352163; RTOG-0324
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00081302
Other Bronchoalveolar Cell Lung Cancer Studies:
1. Vinorelbine Followed by Docetaxel in Treating Patients With Advanced Non-Small Cell Lung Cancer
2. Chemotherapy, Tirapazamine, and Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer
3. Chemotherapy, Amifostine, and Radiation Therapy in Treating Patients With Non-small Cell Lung Cancer
4. Cetuximab, Paclitaxel, Carboplatin, and Radiation Therapy in Treating Patients With Unresectable Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer
5. Positron Emission Tomography for Detecting Non-small Cell Lung Cancer
Related Studies:
Other bronchoalveolar cell lung cancer Clinical Trials
Other Texas Clinical Trials
Other Arlington Clinical Trials
Cetuximab, Paclitaxel, Carboplatin, and Radiation Therapy in Treating Patients With Unresectable Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer
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