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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 Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor 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 devoted 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 take place in many of cities 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 evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, 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 for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated 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. Test subjects oftentimes recieve the best healthcare possible 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. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare 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 > "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 Squamous Cell Lung Cancer Studies:
1. Celecoxib and Docetaxel in Treating Patients With Non-Small Cell Lung Cancer
2. Paclitaxel, Carboplatin, and Radiation Therapy With or Without Adjuvant Paclitaxel and Carboplatin in Treating Patients With Stage II or Stage III Unresectable Non-Small Cell Lung Cancer
3. Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer
4. Radiation Therapy in Treating Patients With Non-small Cell Lung Cancer
5. A Phase II Study of CI-1033 in Treating Patients with Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Related Studies:
Other squamous cell lung cancer Clinical Trials
Other North Carolina Clinical Trials
Other Winston Salem Clinical Trials
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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