Phase Ⅰ/Ⅱ Study of Icotinib Hydrochloride Combined With Intensity-modulated Radiotherapy in Nasopharyngeal Cancer
1. Patients with histological proof of squamous carcinoma of the nasopharynx.
2. Patients must have ECOG Performance Status of 0-1.
3. Patients should have adequate bone marrow function defined as an absolute peripheral
granulocyte count (AGC) of >/= 1500 cells/mm3, platelet count of >/= 100,000
cells/mm3; adequate hepatic function with bilirubin = 1.5mg/dl, AST and ALT = 2x
the upper limit of normal; serum creatinine = 1.5mg/dl, creatinine clearance >/= 50
ml/min and INR 0.8 - 1.2.
4. Patients must sign a study specific informed consent form prior to study entry.
1. Evidence of metastases by clinical or radiographic examinations.
2. History of malignancy other than non-melanoma skin cancer.
3. Prior chemotherapy or anticancer biologic therapy for any type of cancer, or prior
radiotherapy to the head and neck region except for radioactive iodine therapy.
4. Patients with uncontrolled intercurrent disease.
5. Patients with currently active malignancy.
6. Pregnant or lactating women Female patients of childbearing potential who are
unwilling to practice adequate contraception during study treatment and for two
months after the last administration of study drug.