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Ifosfamide and Doxorubicin in Patients With Refractory Nasopharyngeal Carcinoma

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ClinicalTrials.gov Identifier: NCT00484601
Recruitment Status : Terminated
First Posted : June 11, 2007
Last Update Posted : December 17, 2008
Sponsor:
Information provided by:
Sidney Kimmel Comprehensive Cancer Center

Brief 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.

Condition or disease Intervention/treatment Phase
Refractory Nasopharyngeal Carcinoma Drug: Ifosfamide; Doxorubicin Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Ifosfamide and Doxorubicin in Patients With Refractory Nasopharyngeal Carcinoma
Study Start Date : October 2004
Estimated Study Completion Date : September 2010






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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Alex Chang, M.D, Johns Hopkins Singapore International Medical Centre
ClinicalTrials.gov Identifier: NCT00484601     History of Changes
Other Study ID Numbers: JS0327
03-09-11-08
First Posted: June 11, 2007    Key Record Dates
Last Update Posted: December 17, 2008
Last Verified: December 2008

Additional relevant MeSH terms:
Carcinoma
Nasopharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Doxorubicin
Liposomal doxorubicin
Isophosphamide mustard
Ifosfamide
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents