Study Stopped
Low accrual.
Ifosfamide and Doxorubicin in Patients With Refractory Nasopharyngeal Carcinoma
Phase II Study of Ifosfamide and Doxorubicin in Patients With Refractory Nasopharyngeal Carcinoma
2 other identifiers
interventional
9
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Apr 2004
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 15, 2004
CompletedFirst Submitted
Initial submission to the registry
June 8, 2007
CompletedFirst Posted
Study publicly available on registry
June 11, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 7, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
November 7, 2007
CompletedFebruary 11, 2019
February 1, 2019
3.6 years
June 8, 2007
February 7, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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
Prematured termination, data is not analysed.
May 2008
Secondary Outcomes (1)
To correlate EBVDNA titer with clinical response
May 2008
Study Arms (1)
Ifosfamide and Doxorubicin
EXPERIMENTALSingle arm treatment with Ifosfamide and Doxorubicinin patients with Refractory Nasopharyngeal Carcinoma
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Johns Hopkins Singapore International Medical Center
Singapore, 308433, Singapore
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alex Chang, MD
Johns Hopkins Singapore
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 8, 2007
First Posted
June 11, 2007
Study Start
April 15, 2004
Primary Completion
November 7, 2007
Study Completion
November 7, 2007
Last Updated
February 11, 2019
Record last verified: 2019-02