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Paclitaxel Plus Radiation Therapy in Treating Patients With Untreated Stage III 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 Paclitaxel Plus Radiation Therapy in Treating Patients With Untreated Stage III Non-small Cell Lung Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Paclitaxel Plus Radiation Therapy in Treating Patients With Untreated Stage III Non-small Cell Lung Cancer Clinical research trials and Paclitaxel Plus Radiation Therapy in Treating Patients With Untreated Stage III 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 Paclitaxel Plus Radiation Therapy in Treating Patients With Untreated Stage III Non-small Cell Lung Cancer. Paclitaxel Plus Radiation Therapy in Treating Patients With Untreated Stage III 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 Paclitaxel Plus Radiation Therapy in Treating Patients With Untreated Stage III Non-small Cell Lung Cancer clinical trial. Human subjects often receive the most effective healthcare possible for their Paclitaxel Plus Radiation Therapy in Treating Patients With Untreated Stage III 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 > "P" Clinical Trials Conditions > Paclitaxel Plus Radiation Therapy in Treating Patients With Untreated Stage III Non-small Cell Lung Cancer  Paclitaxel Plus Radiation Therapy in Treating Patients With Untreated Stage III Non-small Cell Lung Cancer
Paclitaxel Plus Radiation Therapy in Treating Patients With Untreated Stage III Non-small Cell Lung Cancer
For Condition: stage 3B non-small cell lung cancer,stage 3A non-small cell lung cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Vanderbilt-Ingram Cancer Center
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of chemotherapy with paclitaxel in combination with radiation therapy to the chest in patients with previously untreated stage III non-small cell lung cancer that cannot be surgically removed.
Details: OBJECTIVES: I. Determine the toxicity and maximum tolerated dose of paclitaxel when combined with standard thoracic radiotherapy in patients with locally advanced non-small cell lung cancer. II. Determine the plasma levels of paclitaxel in these patients. III. Determine the effect of this regimen on the tumor cell cycle distribution in these patients. PROTOCOL OUTLINE: This is a dose escalation study of paclitaxel. Patients undergo standard thoracic radiotherapy 5 days a week for 7 weeks and paclitaxel IV continuously beginning 48 hours before initiating radiotherapy and continuing until the last day of radiotherapy in the absence of disease progression or unacceptable toxicity. Cohorts of 3-5 patients receive escalating doses of paclitaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 5 patients experience dose-limiting toxicity. Patients are followed monthly for 2 years. PROJECTED ACCRUAL: A total of 3 to 5 patients per dose level will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven previously untreated non-small cell lung cancer that is not amenable to potentially curative surgery due to the following: Direct invasion of the mediastinum, heart, great vessels, trachea, esophagus, vertebral body, or carina by tumor (T4) Cytologically positive scalene or supraclavicular nodes; Mediastinal or contralateral hilar nodes 3 cm or greater on CT, with or without pathological confirmation; Pathologically positive mediastinal or contralateral hilar nodes on mediastinoscopy or Chamberlain procedure (N2 or N3); Medically inoperable stage IIIA disease (e.g., resection would result in insufficient pulmonary volume) allowed - No distant metastases - No pleural effusion (regardless of fluid cytology) - Evaluable disease --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No prior chemotherapy - Endocrine therapy: Not specified - Radiotherapy: No prior thoracic irradiation - Surgery: See Disease Characteristics - Other: No concurrent medications known to alter cardiac conduction or cause bradycardia (e.g., digoxin, beta blockers, or calcium channel blockers) --Patient Characteristics-- - Age: 18 and over - Performance status: 0-2 - Hematopoietic: WBC normal; Platelet count normal - Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN); Transaminases no greater than 2 times ULN; Alkaline phosphatase no greater than 2 times ULN - Renal: Creatinine less than 2.0 mg/dL - Cardiovascular: No significant coronary artery disease, e.g.: Documented myocardial infarction; Angina, arrhythmia, or congestive heart failure requiring medication - Pulmonary: FEV1 greater than 1 liter; pO2 greater than 55 mm Hg on room air; pCO2 less than 45 mm Hg on room air - Other: No prior severe hypersensitivity reaction to products containing Cremaphor EL; No clinical evidence of pre-existing polyneuropathy; Not pregnant; Negative pregnancy test
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DavidCarbone, Study Chair, Vanderbilt-Ingram Cancer Center
Sarah Cannon-Minnie Pearl Cancer Center
Nashville, Tennessee, 37203
United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104
United States
Vanderbilt Cancer Center
Nashville, Tennessee, 37232-6838
United States
Additional Information:
Study ID Numbers: CDR0000078258; VU-VCC-LUN-65,NCI-T92-0246D,UPCC-3597
Study Start Date: July 1993
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002519
Other Stage 3a Non-Small Cell Lung Cancer Studies:
1. Megestrol in Treating Patients Who Are Undergoing Radiation Therapy for Lung Cancer
2. Combination Chemotherapy as Induction Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer
3. Combination Chemotherapy Plus Radiation Therapy With or Without Gefitinib in Treating Patients With Unresectable Stage III Non-Small Cell Lung Cancer
4. Radiation Therapy in Treating Patients With Non-small Cell Lung Cancer
5. Combination Chemotherapy, Gefitinib, and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer
Related Studies:
Other stage 3A non-small cell lung cancer Clinical Trials
Other Tennessee Clinical Trials
Other Nashville Clinical Trials
Paclitaxel Plus Radiation Therapy in Treating Patients With Untreated Stage III Non-small Cell Lung Cancer
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