Carboplatin Combined With Paclitaxel in Treating Patients With Advanced Thymoma

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.

Inclusion criteria

• Histologically confirmed invasive, recurrent, or metastatic thymoma or thymic carcinoma not amenable to potentially curative therapy by surgery
• Extensive disease (distant disease, pleural disease, pulmonary with or without mediastinal disease, or recurrent progressive disease in site of prior radiotherapy)
• Advanced limited disease allowed if ineligible for primary radiotherapy or surgery
• Measurable disease
• Age 18 and over
• ECOG Performance Status 0-1
• Granulocyte count at least 1,500 cells/mm^3
• Platelet count at least 100,000 cells/mm^3
• Bilirubin no greater than 1.5 mg/dL
• Creatinine no greater than 2.0 mg/dL
• Concurrent corticosteroids for myasthenia gravis or other chronic conditions allowed

Exclusion criteria

• Acute concurrent complications such as infection or post-surgical complications
• Other prior malignancy within the past 5 years unless curatively treated with no evidence of recurrence
• Pregnant or nursing. A negative pregnancy test was required, and fertile patients must use effective contraception
• Prior chemotherapy for metastatic disease. Prior preoperative or adjuvant chemotherapy allowed if disease-free survival prior to recurrence was more than 1 year