Ph II Adjuvant Carboplatin/Docetaxel in Curatively Resected Stage I-IIIA NSCLC
RATIONALE: Drugs used in chemotherapy, such as carboplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving carboplatin together with docetaxel after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well giving carboplatin together with docetaxel works in treating patients with stage I, stage II, or stage III non-small cell lung cancer.
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||Phase II Trial Exploring the Feasibility of Adjuvant Carboplatin/Docetaxel in Curatively Resected Stage I-IIIA Non-Small Cell Lung Cancer|
- Feasibility of administering of carboplatin/docetaxel as adjuvant therapy in resected stage I-IIIA NSCLC [ Time Frame: 12 weeks ]
- Number of subjects with toxicity [ Time Frame: 12 weeks ]Assess the number of subjects experiencing toxicities(per the CTCAE criteria) after receiving carboplatin/docetaxel in the adjuvant setting
|Actual Study Start Date:||May 2004|
|Study Completion Date:||July 2011|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
Single Arm Trial
adjuvant carboplatin plus docetaxel carboplatin area under curve (AUC) = 6 IV on day 1 every 3 weeks for 4 cycles docetaxel 75 mg/m² IV on day 1 every 3 weeks for 4 cycles
Carboplatin will be given intravenously,once,every 3 weeks. The carboplatin area under curve (AUC) dose will be calculated using the Calvert Equation 19 as follows: Carboplatin dose (mg) = 6x (GFR + 25)
Other Name: paraplatinDrug: docetaxel
75 mg/m² intravenously, once, every 3 weeks
Other Name: Taxotere
- Evaluate the feasibility of adjuvant carboplatin and docetaxel in patients with resected stage I, II, or IIIA non-small cell lung cancer.
- Determine the toxicity of this regimen in these patients.
- Determine the survival patterns of patients treated with this regimen.
- Assess the patterns of recurrence in patients treated with this regimen.
OUTLINE: Patients receive carboplatin IV on day 1 and docetaxel IV on day 1. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00280735
|United States, North Carolina|
|University of North Carolina Lineberger Comprehensive Cancer Center|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Mark A. Socinski, MD||UNC Lineberger Comprehensive Cancer Center|