A Randomized Phase II Clinical Trial of an Adenovirus-mediated Endostatin Gene (E10A) Combined With Cisplatin and Paclitaxel in Patients With Head and Neck Cancer
Inclusion Criteria:
- histologically or cytologically confirmed recurrent or metastatic head and neck
squamous carcinoma or nasopharyngeal carcinoma
- the tumor was amenable to direct injection and measurement ( > 2 cm)
- an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- a life expectancy over three months
- the absence of serious medical or psychiatric disorders
- serum creatinine < 1.5 mg/dL; WBC count >3,000/mm3, platelet count > 80,000/mm3,
hemoglobin > 8 g/dL; total bilirubin value < 1.5 times the upper limit of normal
[ULN], ALT level < 2.5 times ULN, AST < 2.5 times ULN.
Exclusion Criteria:
- pregnant or breast feeding
- a history of brain metastases or a primary brain tumor
- a history of hemorrhagic diathesis
- a history of corticosteroids or immunosuppressives use within four weeks of study
entry
- a history of immune deficiency disorder or organ transplant
- has evidence of active adenovirus infection or uncontrolled infection
- received any chemotherapy or radiotherapy within four weeks of study entry