Overview

Ifosfamide and Doxorubicin in Patients With Refractory Nasopharyngeal Carcinoma

Status:
Terminated
Trial end date:
2007-11-07
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Treatments:
Doxorubicin
Ifosfamide
Isophosphamide mustard
Liposomal doxorubicin
Criteria
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