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Phase II Study of Ifosfamide and Doxorubicin in Patients With Refractory Nasopharyngeal Carcinoma

Phase 2
18 Years
Not Enrolling
Refractory Nasopharyngeal Carcinoma

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Trial Information

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.

Inclusion Criteria:

- Histological diagnosis of NPC

- Age > 18 years old

- Measurable metastatic or recurrent disease (s)

- Received one prior chemotherapy regimen for metastatic or recurrent NPC which
relapsed or became refractory before entry.

- ECOG PS 0, 1 or 2

- WBC > 3,500/uL and ANC > 1,500/uL Platelet > 100,000/uL Creatinine - within normal
limits SGOT < 3 X UNL Bilirubin < 2.0 mg/dL

- Ejection fraction > 45% and no history of myocardial infarction or congestive heart
failure in the last 6 months. No history of cardiac ventricular arrythmia or
ventricle tachycardia, or uncontrolled atrial fibrillation or supraventricular
tachycardia with hemodynamic compromising status.

- Random blood glucose level < 250 mg

- Signed informed consent

Exclusion Criteria:

- Received more than one prior chemotherapy for metastatic or recurrent disease

- Ejection fraction < 45%

- WBC < 3,500/UL or ANC < 1,500/UL or P/t < 100,000/UL or SCOT> 3 x UNL or
Bilirubin > 2.0 mg/dL or Creatinine > UNL

- ECOG PS > 3

- Hx of myocardial infarction within last 6 months

- Random blood glucose level less than or equal 250 mg

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Alex Chang, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Johns Hopkins SIngapore International Medical Center


United States: Institutional Review Board

Study ID:




Start Date:

October 2004

Completion Date:

September 2010

Related Keywords:

  • Refractory Nasopharyngeal Carcinoma
  • Carcinoma
  • Nasopharyngeal Neoplasms