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Ifosfamide and Doxorubicin in Patients With Refractory Nasopharyngeal Carcinoma
This study has been terminated.
Sponsored by: Sidney Kimmel Comprehensive Cancer Center
Information provided by: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00484601
  Purpose

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.


Condition Intervention Phase
Refractory Nasopharyngeal Carcinoma
Drug: Ifosfamide; Doxorubicin
Phase II

MedlinePlus related topics: Cancer
Drug Information available for: Doxorubicin Doxorubicin hydrochloride Ifosfamide
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title: Phase II Study of Ifosfamide and Doxorubicin in Patients With Refractory Nasopharyngeal Carcinoma

Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Estimated Enrollment: 35
Study Start Date: October 2004
Estimated Study Completion Date: September 2010
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00484601

Locations
Singapore
Johns Hopkins Singapore International Medical Center
Singapore, Singapore, 308433
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
Principal Investigator: Alex Chang, MD Johns Hopkins SIngapore International Medical Center
  More Information

Responsible Party: Johns Hopkins Singapore International Medical Centre ( Alex Chang, M.D )
Study ID Numbers: JS0327, 03-09-11-08
Study First Received: June 8, 2007
Last Updated: December 16, 2008
ClinicalTrials.gov Identifier: NCT00484601  
Health Authority: United States: Institutional Review Board;   Singapore: Domain Specific Review Boards;   Singapore: Health Sciences Authority

Study placed in the following topic categories:
Otorhinolaryngologic Neoplasms
Otorhinolaryngologic Diseases
Pharyngeal Neoplasms
Pharyngeal Diseases
Nasopharyngeal Neoplasms
Doxorubicin
Carcinoma
Ifosfamide
Nasopharyngeal carcinoma
Mechlorethamine
Head and Neck Neoplasms
Stomatognathic Diseases
Neoplasms, Glandular and Epithelial
Isophosphamide mustard

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Nasopharyngeal Diseases
Antineoplastic Agents, Alkylating
Antibiotics, Antineoplastic
Alkylating Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009