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