Chemotherapy, Amifostine, and Radiation Therapy in Treating Patients With Non-small Cell Lung Cancer
- Conditions
- Drug/Agent Toxicity by Tissue/OrganLung Cancer
- Registration Number
- NCT00003089
- Brief Summary
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.
- Detailed Description
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.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States