A Phase II Trial of Chemotherapy Plus Cetuximab Followed by Surgical Resection in Patients With Locally Advanced or Recurrent Thymoma or Thymic Carcinoma

Inclusion Criteria:

- Age>18

- Karnofsky Performance Status (KPS) ≥ 70

- Newly diagnosed or recurrent thymoma - WHO A, AB, B1, B2, or B340, or thymic
carcinoma pathologically confirmed at MSKCC or MDACC

- No prior chemotherapy, radiotherapy, or surgical therapy (other than for diagnostic
biopsy) for thymoma

- No prior treatment with cetuximab

- Clinical Masaoka Stage II (>5cm), III, or IVA(See Appendix B), including suspected
invasion of mediastinum, pericardium, lung, great vessels or chest wall, and/or
pleural metastases Normal marrow function: leukocytes ≥ 4,000/μl, absolute neutrophil
count ≥ 1,500/μl, platelets ≥ 160,000/μl

- Adequate renal function, with creatinine ≤ 1.3 mg/dl or calculated creatinine
clearance ≥60ml/min by Cockcroft and Gault equation using parameters of age, weight
(kg), and baseline serum creatinine (mg/dl)

- Adequate hepatic function: Total bilirubin ≤1.5 mg/dl, AST ≤1.5X UNL, alkaline
phosphatase ≤1.5 UN

- Signed informed consent

- Effective contraception

- Medically operable

Exclusion Criteria:

- Evidence of distant metastatic disease (Masaoka stage IVB)

- Thymic carcinoid

- Patients must not be receiving any other investigational agents

- Concurrent or prior malignancy in the last 5 years other than non-melanoma skin
cancer and in-situ carcinoma of the cervix

- Known HIV-positive patients receiving combination anti-retroviral therapy are
excluded from the study because of possible pharmacokinetic interactions with the
study drugs. Patients on medications known to alter CYP3A4

- Pregnant or breastfeeding women