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Radiation Therapy Plus Topotecan in Treating Patients With 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 Radiation Therapy Plus Topotecan in Treating Patients With Non-small Cell Lung Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Radiation Therapy Plus Topotecan in Treating Patients With Non-small Cell Lung Cancer Clinical research trials and Radiation Therapy Plus Topotecan in Treating Patients With 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 Radiation Therapy Plus Topotecan in Treating Patients With Non-small Cell Lung Cancer. Radiation Therapy Plus Topotecan in Treating Patients With 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 Radiation Therapy Plus Topotecan in Treating Patients With Non-small Cell Lung Cancer clinical trial. Participants typically obtain the most effective healthcare available for their Radiation Therapy Plus Topotecan in Treating Patients With 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 > "R" Clinical Trials Conditions > Radiation Therapy Plus Topotecan in Treating Patients With Non-small Cell Lung Cancer  Radiation Therapy Plus Topotecan in Treating Patients With Non-small Cell Lung Cancer
Radiation Therapy Plus Topotecan in Treating Patients With Non-small Cell Lung Cancer
For Condition: stage 3B non-small cell lung cancer,recurrent non-small cell lung cancer,stage 3A non-small cell lung cancer,stage 4 non-small cell lung cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Kaplan Cancer Center
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy and radiation therapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of radiation therapy plus topotecan in treating patients who have non-small cell lung cancer.
Details: OBJECTIVES: I. Determine the maximum tolerated dose of topotecan and chest irradiation in patients with non-small cell lung cancer. II. Determine the qualitative and quantitative toxic effects of this regimen in these patients. III. Determine the degree of antitumor activity of this regimen in these patients. PROTOCOL OUTLINE: This is a dose escalation study of topotecan and thoracic radiotherapy. Beginning on day 1, patients receive topotecan IV continuously for 3-6 weeks and thoracic radiotherapy 5 days a week for 2, 3, or 6 weeks. Cohorts of 4-6 patients receive escalating doses of topotecan and thoracic radiotherapy until the maximum tolerated dose (MTD) of each therapy is determined. The MTD is defined as the dose preceding that at which 2 of 4 or 6 patients experience dose-limiting toxicity. Six additional patients are treated at the MTD. Patients who fail to achieve complete remission (CR) and continue to have measurable disease at 4-6 weeks after completion of radiotherapy receive topotecan IV continuously on days 1-21 at 1 dose level preceding the MTD as determined by the ongoing Protocol NYU-9123. Treatment continues every 4 weeks in the absence of unacceptable toxicity. PROJECTED ACCRUAL: Approximately 10-20 patients will be accrued within 8-12 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven non-small cell lung cancer - Eligible for chest irradiation with 3,000 to 6,000 cGy (based upon standard radiotherapy indications) - Measurable or evaluable disease; Measurable disease defined as bidimensionally measurable lesion on physical exam or radiograph (CT or MRI acceptable) --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No more than 1 prior chemotherapy regimen allowed; At least 4 weeks since prior chemotherapy and recovered - Endocrine therapy: Not specified - Radiotherapy: No prior radiotherapy - Surgery: Not specified - Other: Recovered from toxic effects of any prior therapy --Patient Characteristics-- - Age: 18 and over - Performance status: 0-2 - Life expectancy: At least 12 weeks - Hematopoietic: WBC at least 4,000/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than 1.5 mg/dL; AST less than 3 times normal; Alkaline phosphatase less than 3 times normal - Renal: Creatinine no greater than 1.5 mg/dL - Other: Not pregnant or nursing
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HowardHochster, Study Chair, Kaplan Cancer Center
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York City, New York, 10016
United States
Additional Information:
Study ID Numbers: CDR0000078480; NYU-9301,NCI-T93-0015D
Study Start Date: September 1993
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002537
Other Stage 3a Non-Small Cell Lung Cancer Studies:
1. A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Phase III Study of Tariquidar + Vinorelbine as First-Line Therapy in Non-Small Cell Lung Cancer (NSCLC)
2. Ro 50-3821 in Treating Anemia in Patients Receiving Antineoplastic Therapy for Stage IIIB or Stage IV Non-Small Cell Lung Cancer
3. CCI-779 in Treating Patients With Stage IIIB (With Pleural Effusion) or Stage IV Non-Small Cell Lung Cancer
4. Carboplatin and Paclitaxel in Treating Older Patients With Metastatic or Recurrent Unresectable Non-small Cell Lung Cancer
5. Standard Therapy Given With or Without Combination Chemotherapy in Treating Patients With Non-small Cell Lung Cancer
Related Studies:
Other stage 3A non-small cell lung cancer Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Radiation Therapy Plus Topotecan in Treating Patients With Non-small Cell Lung Cancer
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