Paclitaxel and Cisplatin for Thymic Neoplasm

A Phase II Study of Paclitaxel and Cisplatin in Previously Untreated, Unresectable Invasive Thymoma or Thymic Carcinoma

To assess the efficacy and safety of the regimen in previously untreated, unresectable invasive thymoma or thymic carcinoma

Inclusion Criteria:

• histologically or cytologically confirmed invasive thymoma or thymic carcinoma
• unresectable tumor: by either local invasion, distant metastasis, or recurred (assessed by investigator)
• no previous systemic treatment for invasive thymoma or thymic carcinoma
• at least one measurable lesion by RECIST criteria
• 18 years old or older
• ECOG performance status 0, 1, 2
• adequate lab. findings neutrophil ≥ 1.5 x 10^9/L platelet ≥ 75 x 10^9/L hemoglobin ≥ 9.0 g/dL bilirubin ≤ 1.5 x upper normal limit AST, ALT ≤ 2.5 x upper normal limit Alkaline phosphatase ≤ 2.5 x upper normal limit (if liver metastasis, ≤ 5 x upper normal limit) serum creatinine ≤ 1.0 x upper normal limit if serum creatinine > 1.0 x upper normal limit, creatinine clearance ≥ 60 mL/min
• patient who agree to written, informed consent

Exclusion Criteria:

• other malignancy (exception: non-melanoma skin cancer, cervical carcinoma in situ, cancer without evidence more than 5 years since curative resection)
• active bacterial infection
• history of clinical trial with investigational drug within 30 days
• radiotherapy to thoracic or mediastinal area (other area radiotherapy is permitted)
• pregnant, or lactating women
• patient with organ transplantation
• peripheral neuropathy, grade 2 or greater
• severe, medical condition unstable cardiac disease despite of adequate management myocardial infarction within 6 months active ulcer disease refractory to medication chronic obstructive lung disease requiring admission treatment within 1 year
• uncontrolled seizure, cerebral nervous system disorder, psychiatric problem which decrease treatment compliance