Phase II Study of Ifosfamide and Doxorubicin in Patients With Refractory Nasopharyngeal Carcinoma
Nasopharyngeal Cancer (NPC) is one of the common cancer in Southeast Asia. In this region
NPC is associated with Epstein Barr Virus (EBV) chronic infection with EBV DNA identifiable
in almost all the NPC tumors and patient's serum at the time of diagnosis. Chinese,
especially cantonese has the highest incidence. Only about 30% of patients presents early
disease and has a good treatment outcome (80% cure for stage I disease and 70% for stage II
by radiation).
This research is to test the effectiveness and toxicity of both Ifosfamide and Doxorubicin.
It also aims to explore the relationship between EBV DNA and clinical response in patients
with advanced naso-pharyngeal cancer which has been previously treated with chemotherapy.
Investigators believe EBV infection is necessary to cause NPC and that EBV DNA levels in the
blood may directly relate to the total size of the tumor. Because NPC patients in this
situation have a poor outlook, we design this study to evaluate the combination of
Ifosfamide and doxorubicin for further treatment. While this combination of medicines has
been used in many other forms of cancer, it has not been tested in patients with NPC.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Alex Chang, MD
Principal Investigator
Johns Hopkins SIngapore International Medical Center
United States: Institutional Review Board
JS0327
NCT00484601
October 2004
September 2010
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