Chemotherapy, Amifostine, and Radiation Therapy in Treating Patients With Non-small Cell Lung Cancer
|ClinicalTrials.gov Identifier: NCT00003089|
Recruitment Status : Completed
First Posted : February 19, 2004
Last Update Posted : July 10, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Drug/Agent Toxicity by Tissue/Organ Lung Cancer||Drug: amifostine trihydrate Drug: carboplatin Drug: paclitaxel Radiation: radiation therapy||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||A Phase II Trial of Induction Paclitaxel Plus Carboplatin Followed by Thoracic Radiation Therapy With Concurrent Weekly Low-Dose Paclitaxel and Twice Weekly Amifostine for Patients With Unresectable Locally Advanced or Partially Resected Non-Small Cell Lung Cancer|
|Study Start Date :||July 1997|
|Actual Study Completion Date :||February 2004|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003089
|United States, Pennsylvania|
|Kimmel Cancer Center of Thomas Jefferson University - Philadelphia|
|Philadelphia, Pennsylvania, United States, 19107-5541|
|Study Chair:||Maria Werner-Wasik, MD||Sidney Kimmel Cancer Center at Thomas Jefferson University|