Carboplatin Combined With Paclitaxel in Treating Patients With Advanced Thymoma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of carboplatin combined with paclitaxel in treating patients who have advanced thymoma.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study Of Carboplatin Plus Paclitaxel Treatment Of Advanced Thymoma Or Thymic Carcinoma|
- Best Overall Response by RECIST Criteria (Version 1.0) [ Time Frame: Assessed every 2 cycles (6 weeks) ] [ Designated as safety issue: No ]Number of eligible, treated participants in each response category by RECIST criteria
- Duration of Response [ Time Frame: assessed every 3 months for 2 years, then every 6 months for 3 years, then annually thereafter ] [ Designated as safety issue: No ]Time from first satisfaction of response criteria to onset of disease progression, assessed using RECIST criteria
|Study Start Date:||February 2001|
|Study Completion Date:||August 2012|
|Primary Completion Date:||November 2008 (Final data collection date for primary outcome measure)|
Experimental: Paclitaxel plus Carboplatin
Paclitaxel 225 mg/m2 IV over 3 hours and Carboplatin AUC 6.0 IV over 30 minutes on day 1 of a 21-day cycle
Dosed to AUC of 6.0, given IV over 30 minutes day 1 of a 21-day cycle, for up to 6 cycles
Other Names:Drug: paclitaxel
225 mg/m2 given by intravenous (IV) infusion over 3 hours on day 1 of a 21-day cycle, for up to 6 cycles
- Determine the objective response rate in patients with advanced thymoma or thymic carcinoma treated with carboplatin and paclitaxel.
- Determine the duration of response in these patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
OUTLINE: Patients receive paclitaxel by intravenous (IV) infusion over 3 hours followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression. Patients achieving complete or partial remission or stable disease receive 4 additional courses of therapy for a maximum of 6 courses. Further treatment may be given at the discretion of the treating physician.
Patients were followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 35-68 patients were to be accrued for this study within 3.8-4.6 years.