Ifosfamide and Doxorubicin in Patients With Refractory Nasopharyngeal Carcinoma
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|ClinicalTrials.gov Identifier: NCT00484601|
Recruitment Status : Terminated (Low accrual.)
First Posted : June 11, 2007
Last Update Posted : February 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Refractory Nasopharyngeal Carcinoma||Drug: Ifosfamide Drug: Doxorubicin||Phase 2|
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)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Ifosfamide and Doxorubicin in Patients With Refractory Nasopharyngeal Carcinoma|
|Actual Study Start Date :||April 15, 2004|
|Actual Primary Completion Date :||November 7, 2007|
|Actual Study Completion Date :||November 7, 2007|
Experimental: Ifosfamide and Doxorubicin
Single arm treatment with Ifosfamide and Doxorubicinin patients with Refractory Nasopharyngeal Carcinoma
- To evaluate the overall response rate and toxicity including complete response rate, response duration, time to treatment failure, and survival of ifosfamide and doxorubicin as the second line chemotherapy for patients with advanced NPC [ Time Frame: May 2008 ]Prematured termination, data is not analysed.
- To correlate EBVDNA titer with clinical response [ Time Frame: May 2008 ]Prematured termination, data is not analysed.
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
|Johns Hopkins Singapore International Medical Center|
|Singapore, Singapore, 308433|
|Principal Investigator:||Alex Chang, MD||Johns Hopkins Singapore|