Status:
COMPLETED
Study of Combination of Sorafenib With Cisplatin and 5-fluorouracil as First-line Treatment of Recurrence After Radiotherapy Patients Who Failed With Radiotherapy in Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC)
Lead Sponsor:
Sun Yat-sen University
Conditions:
Nasopharyngeal Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study is a phase II clinical study. Recurrence after radiotherapy patients who are failure of radiotherapy in recurrent or metastatic nasopharyngeal carcinoma (NPC) were treated by cisplatin and ...
Eligibility Criteria
Inclusion
- Age \> 18 years
- ECOG Performance Status of 0 or 1
- Life expectancy of at least 12 weeks
- Pathologically confirmed nasopharyngeal carcinoma
- Experience of treatment failure with radiotherapy for recurrent or metastatic NPC
- More than 3 weeks must have elapsed since previous radiotherapy
- Biomarkers measuring including pERK, EGFR of original diagnostic paraffin-embedded tumor samples; VEGF of pre-dose and post-dose plasma samples.
- Subjects with at least one (for RECIST) measurable lesion (Tumor lesions that are situated in a previously irradiated area could not be considered measurable)
- Adequate bone marrow, liver and renal functions as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
- Hemoglobin \> 9.0 g/dl
- Absolute neutrophil count (ANC) \> 1,500/mm3
- Platelet count \> 100,000/μl
- Total bilirubin \< 1.5 times the upper limit of normal
- ALT and AST \< 2.5 x upper limit of normal (\< 5 x upper limit of normal for patients with liver involvement of their cancer), Alkaline phosphatase \< 4 x ULN ,PT-INR/PTT \< 1.5 x upper limit of normal, Serum creatinine \< 1.5 x upper limit of normal
- Signed and dated informed consent before the start of specific protocol procedures
Exclusion
- History of cardiac disease: congestive heart failure \> NYHA class 2; active CAD (MI more than 6 mo prior to study entry is allowed); cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted) or uncontrolled hypertension.
- History of HIV infection
- Active clinically serious infections (\> grade 2 NCI-CTC version 3.0)
- Symptomatic metastatic brain or meningeal tumors (unless the patient is \> 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry)
- History of organ allograft the organ allograft may be allowed as protocol specific.
- Patients with evidence or history of bleeding diatheses
- Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors \[Ta, Tis \& T1\] or any cancer curatively treated \> 3 years prior to study entry.
- Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and two weeks after the completion of trial.
- Patients unable to swallow oral medications
- Prior use of farnesyl transferase, Raf kinase, or MEK inhibitors
- Investigational drug therapy outside of this trial during or within 4 weeks of study entry
- Prior exposure to the study drug
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00747799
Start Date
January 1 2009
End Date
November 1 2011
Last Update
December 10 2013
Active Locations (1)
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1
Cancer Center of Sun-Yat Sen University
Guangzhou, Guangdong, China, 510000