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Ifosfamide and Doxorubicin in Patients With Refractory Nasopharyngeal Carcinoma

This study has been terminated.
Sponsor:
Information provided by:
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00484601
First received: June 8, 2007
Last updated: December 16, 2008
Last verified: December 2008

June 8, 2007
December 16, 2008
October 2004
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Complete list of historical versions of study NCT00484601 on ClinicalTrials.gov Archive Site
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Ifosfamide and Doxorubicin in Patients With Refractory Nasopharyngeal Carcinoma
Phase II Study of Ifosfamide and Doxorubicin in Patients With Refractory Nasopharyngeal Carcinoma

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.

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
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Refractory Nasopharyngeal Carcinoma
Drug: Ifosfamide; Doxorubicin
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
35
September 2010
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Singapore
 
NCT00484601
JS0327, 03-09-11-08
No
Alex Chang, M.D, Johns Hopkins Singapore International Medical Centre
Sidney Kimmel Comprehensive Cancer Center
Not Provided
Principal Investigator: Alex Chang, MD Johns Hopkins SIngapore International Medical Center
Sidney Kimmel Comprehensive Cancer Center
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP