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Chemotherapy and Radiation Therapy With or Without Epoetin alfa in Treating Patients With Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Chemotherapy and Radiation Therapy With or Without Epoetin alfa in Treating Patients With Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Chemotherapy and Radiation Therapy With or Without Epoetin alfa in Treating Patients With Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer Clinical research trials and Chemotherapy and Radiation Therapy With or Without Epoetin alfa in Treating Patients With Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer healthcare trials occur in a lot of of places throughout 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 potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Chemotherapy and Radiation Therapy With or Without Epoetin alfa in Treating Patients With Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer. Chemotherapy and Radiation Therapy With or Without Epoetin alfa in Treating Patients With Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Chemotherapy and Radiation Therapy With or Without Epoetin alfa in Treating Patients With Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer clinical trial. Participants typically obtain the most effective healthcare available for their Chemotherapy and Radiation Therapy With or Without Epoetin alfa in Treating Patients With Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Chemotherapy and Radiation Therapy With or Without Epoetin alfa in Treating Patients With Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer  Chemotherapy and Radiation Therapy With or Without Epoetin alfa in Treating Patients With Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer
Chemotherapy and Radiation Therapy With or Without Epoetin alfa in Treating Patients With Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer
For Condition: stage 3B non-small cell lung cancer,large cell lung cancer,stage 3A non-small cell lung cancer,adenocarcinoma of the lung,bronchoalveolar cell lung cancer,squamous cell lung cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Comprehensive Cancer Center of Wake Forest University
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. Epoetin alfa may stimulate red blood cell production and prevent or treat anemia in patients who are undergoing radiation therapy and chemotherapy. It is not yet known if chemotherapy combined with radiation therapy is more effective with or without epoetin alfa in treating non-small cell lung cancer. PURPOSE: Randomized phase III trial to determine the effectiveness of chemotherapy combined with radiation therapy with or without epoetin alfa in treating patients who have stage IIIA or stage IIIB non-small cell lung cancer.
Details: OBJECTIVES: I. Determine the efficacy of epoetin alfa in maintaining hemoglobin levels in patients with stage IIIA or IIIB non-small cell lung cancer when treated with chemoradiotherapy. II. Compare the time to local and systemic progression in patients receiving chemoradiotherapy with or without epoetin alfa. III. Compare tumor response rate and overall survival in patients treated with these regimens. IV. Compare the toxicity of these regimens in these patients. V. Compare quality of life in patients treated with these regimens. VI. Compare the number of transfusions in patients treated with these regimens. PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are stratified according to Karnofsky performance status (90-100% vs 60-80%), weight loss (no more than 5% vs 6-10%), and baseline hemoglobin (women 11.0-12.4 g/dL and men 11.0-13.4 g/dL vs women 12.5-15.0 g/dL and men 13.5-15.0 g/dL). Patients are randomized to 1 of 2 treatment arms. Arm I: Beginning 7-10 days before the start of chemoradiotherapy, patients receive epoetin alfa subcutaneously once weekly for 8 weeks. Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes once weekly for 7 weeks. Patients undergo radiotherapy 5 days a week for 7 weeks for a total of 33 treatments. Treatment continues in the absence of disease progression or unacceptable toxicity. Arm II: Patients receive paclitaxel, carboplatin, and radiotherapy as in arm I. Quality of life is assessed at baseline, at completion of chemoradiotherapy, every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years. Patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 202-232 patients (101-116 per treatment arm) will be accrued for this study within 1.7-2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Histologically or cytologically confirmed stage IIIA or IIIB non-small cell lung cancer (NSCLC) - Squamous cell carcinoma - Adenocarcinoma (including bronchoalveolar cell) - Large cell anaplastic carcinoma (including giant and clear cell carcinomas) --Prior/Concurrent Therapy-- Biologic therapy: - At least 30 days since prior transfusion - No prior epoetin alfa or experimental forms of epoetin alfa Chemotherapy: No prior chemotherapy for NSCLC Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy for NSCLC Surgery: At least 2 weeks since prior thoracotomy Other: - No concurrent therapy for iron, folate, or B12 deficiency - No other concurrent anti-cancer therapy --Patient Characteristics-- Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: - Granulocyte count at least 1,500/mm3 - Platelet count at least 100,000/mm3 - Hemoglobin 11.0-15 g/dL - If hemoglobin is 11.0-11.9 g/dL then the following lab values are required: *Iron greater than 60 mcg/mL *Transferrin saturation greater than 20% *Ferritin at least 100 mg/mL *Iron binding capacity less than 400 mcg/dL *RBC folate normal *B12 normal Hepatic: - Bilirubin less than 1.5 mg/dL - AST less than 2 times upper limit of normal Renal: Creatinine clearance at least 20 mL/min Cardiovascular: No uncontrolled hypertension Pulmonary: FEV1 at least 0.8 L Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No known hypersensitivity to mammalian cell-derived products or human albumin - No other concurrent or prior malignancy within the past 2 years except non- melanoma skin cancers
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ArthurBlackstock, Study Chair, Comprehensive Cancer Center of Wake Forest University
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1082
United States
Additional Information:
Study ID Numbers: CDR0000069148; CCCWFU-BG01-193,NCI-P01-0200,CCCWFU-62299
Study Start Date: January 2002
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00028938
Other Adenocarcinoma Of The Lung Studies:
1. Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Advanced, Metastatic, or Recurrent Non-Small Cell Lung Cancer
2. Soblidotin in Treating Patients With Progressive Locally Advanced or Metastatic Non-Small Cell Lung Cancer
3. Chemotherapy, Tirapazamine, and Radiation Therapy in Treating Patients With 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. Celecoxib and Erlotinib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
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Chemotherapy and Radiation Therapy With or Without Epoetin alfa in Treating Patients With Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer
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