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Chemotherapy, Amifostine, and Radiation Therapy in Treating Patients With Non-small Cell Lung Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Chemotherapy, Amifostine, and Radiation Therapy in Treating Patients With Non-small Cell Lung Cancer conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Chemotherapy, Amifostine, and Radiation Therapy in Treating Patients With Non-small Cell Lung Cancer Clinical research trials and Chemotherapy, Amifostine, and Radiation Therapy in Treating Patients With Non-small Cell Lung Cancer health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Chemotherapy, Amifostine, and Radiation Therapy in Treating Patients With Non-small Cell Lung Cancer. Chemotherapy, Amifostine, and Radiation Therapy in Treating Patients With Non-small Cell Lung Cancer Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Chemotherapy, Amifostine, and Radiation Therapy in Treating Patients With Non-small Cell Lung Cancer clinical trial. Participants oftentimes recieve the most expert healthcare available for their Chemotherapy, Amifostine, and Radiation Therapy in Treating Patients With Non-small Cell Lung Cancer condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Chemotherapy, Amifostine, and Radiation Therapy in Treating Patients With Non-small Cell Lung Cancer  Chemotherapy, Amifostine, and Radiation Therapy in Treating Patients With Non-small Cell Lung Cancer
Chemotherapy, Amifostine, and Radiation Therapy in Treating Patients With Non-small Cell Lung Cancer
For Condition: stage 3A non-small cell lung cancer,squamous cell lung cancer,adenocarcinoma of the lung,large cell lung cancer,Drug Toxicity,stage 2 non-small cell lung cancer,stage 3B non-small cell lung cancer
Status: Completed
Sponsor(s): Kimmel Cancer Center (KCC) ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as amifostine, may protect normal cells from the side effects of chemotherapy. Radiation therapy uses high-energy x-rays to damage tumor cells. PURPOSE: Phase II trial to study the effectiveness of paclitaxel, carboplatin, amifostine, and radiation therapy in treating patients who have unresectable locally advanced or partially resected non-small cell lung cancer.
Details: OBJECTIVES: I. Determine the toxic effects and antitumor efficacy of paclitaxel plus carboplatin in patients with unresectable, intrathoracic non-small cell lung cancer (NSCLC). II. Integrate concurrent thoracic radiation therapy and weekly low dose paclitaxel into treatment of this patient population. III. Investigate a primary chemoradiotherapy treatment approach in a population of patients selected on the basis of performance status regardless of degree of weight loss. IV. Determine the effect of amifostine on the incidence of treatment nonhematologic toxic effects, specifically esophagitis, pneumonitis, and radiation dermatitis, in these patients. PROTOCOL OUTLINE: This is an open label study. Patients receive induction therapy comprising paclitaxel IV over 3 hours followed by carboplatin IV over 1 hour on days 1 and 21. Patients then undergo radiotherapy beginning on day 42 (or no later than day 63) daily 5 days a week for 7 weeks. Patients also receive amifostine IV over 15 minutes followed by paclitaxel IV over 3 hours weekly (day 1 each week) concurrently for the duration of radiotherapy. On 2 other days of the week, patients receive amifostine alone preceding thoracic radiotherapy. Patients are followed every 3 months for 1 year and then every 6 months until disease progression or death. PROJECTED ACCRUAL: Approximately 15-35 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Educational/Counseling/Training
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven non-small cell lung cancer; Adenocarcinoma; Squamous cell carcinoma; Large cell carcinoma; Undifferentiated carcinoma - Stages II-IIIB; Medically inoperable stage II and IIIA; Unresectable stage IIIA and IIIB - Partial resection of stage IIIA or IIIB disease with histologically proven mediastinal lymph node involvement with microscopic or measurable disease - Ineligible for RTOG 9410 or RTOG 9304 - Men with elevated PSA no greater than 10 and no clinical evidence of prostate carcinoma are eligible - No pleural effusion large enough to be visible by plain chest radiograph, unless proven to be benign - Limited metastatic disease (no liver metastases) defined as: No more than 3 lung nodules outside the primary tumor suspected to be metastatic OR No more than 3 sites of suspected metastatic disease seen on bone scan or skeletal films OR 1-3 brain metastases, with plans for whole brain irradiation, with or without surgery or radiosurgery OR Single adrenal metastases not exceeding 3 cm in size --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No prior chemotherapy - Endocrine therapy: Not specified - Radiotherapy: No prior thoracic radiotherapy - Surgery: See Disease Characteristics --Patient Characteristics-- - Age: Adult - Performance status: ECOG 0-1 OR Karnofsky 70-100% - Life expectancy: Not specified - Hematopoietic: Absolute neutrophil count greater than 2,000/mm3; Platelet count greater than 100,000/mm3; Hemoglobin greater than 8 g/dL - Hepatic: Transaminases less than 1.5 times normal; Bilirubin less than 2.0 mg/dL - Renal: Creatinine less than 1.8 mg/dL - Other: No concurrent severe medical problems; Calorie intake of at least 1500 kcal/day; No history of active malignancy within one year except: Basal cell carcinoma of the skin; Squamous cell carcinoma of the skin; Superficial transitional cell carcinoma of the urothelium; Cervical intraepithelial neoplasia Stage I cancer of the endometrium; Stage I cancer of the upper aerodigestive tract
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MariaWerner-Wasik, Study Chair, Kimmel Cancer Center (KCC)
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107-5541
United States
Additional Information:
Study ID Numbers: CDR0000065792; TJUH-969139,NCI-V97-1343,ALZA-97-019-ii
Study Start Date: July 1997
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003089
Other Stage 3a Non-Small Cell Lung Cancer Studies:
1. Combination Chemotherapy and Radiation Therapy in Treating Patients With Stage II or Stage III Non-small Cell Lung Cancer That Cannot Be Removed By Surgery
2. Combination Chemotherapy and Radiation Therapy Followed By Surgery in Treating Patients With Stage IIB or Stage IIIA Non-Small Cell Lung Cancer
3. Chemotherapy Plus Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer
4. Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer That Can Not Be Surgically Removed
5. Marimastat in Treating Patients With Stage III Non-small Cell Lung Cancer
Related Studies:
Other stage 3A non-small cell lung cancer Clinical Trials
Other Pennsylvania Clinical Trials
Other Philadelphia Clinical Trials
Chemotherapy, Amifostine, and Radiation Therapy in Treating Patients With Non-small Cell Lung Cancer
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