Conditions: Thymoma Thymic Carcinoma
Keywords: thymoma thymic carcinoma
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 46
Healthy volunteers: no

Brief summary:
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.

Detailed description:
OBJECTIVES:

* 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.

Arms:
arm 1: 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

Interventions: intervention 1: carboplatin intervention 2: paclitaxel
Intervention descriptions: intervention 1: Dosed to AUC of 6.0, given IV over 30 minutes day 1 of a 21-day cycle, for up to 6 cycles intervention 2: 225 mg/m2 given by intravenous (IV) infusion over 3 hours on day 1 of a 21-day cycle, for up to 6 cycles

Protocol document: