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)

Phase 2

Completed

• Conditions: Nasopharyngeal Neoplasms
• Interventions: Drug: Sorafenib plus Cisplatin and 5-fluorouracil

• Registration Number: NCT00747799
• Lead Sponsor: Sun Yat-sen University

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 5-fluorouracil with Sorafenib as first-line treatment. The objective response(complete response (CR) + partial response (PR)), Disease Control Rate , safety profile, tolerability will be evaluated according to World Health Organization (WHO) criteria.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-09-04
• Study First Submitted QC: 2008-09-04
• Study First Posted: 2008-09-05
• Study Start: 2009-01
• Primary Completion: 2011-05
• Status Verified: 2011-11
• Study Completion: 2011-11
• Last Update Submitted: 2013-12-08
• Last Update Posted: 2013-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

1. Age > 18 years

2. ECOG Performance Status of 0 or 1

3. Life expectancy of at least 12 weeks

4. Pathologically confirmed nasopharyngeal carcinoma

5. Experience of treatment failure with radiotherapy for recurrent or metastatic NPC

6. More than 3 weeks must have elapsed since previous radiotherapy

7. Biomarkers measuring including pERK, EGFR of original diagnostic paraffin-embedded tumor samples; VEGF of pre-dose and post-dose plasma samples.

8. Subjects with at least one (for RECIST) measurable lesion (Tumor lesions that are situated in a previously irradiated area could not be considered measurable)

9. 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

10. Signed and dated informed consent before the start of specific protocol procedures

Exclusion Criteria

1. 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.
2. History of HIV infection
3. Active clinically serious infections (> grade 2 NCI-CTC version 3.0)
4. 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)
5. History of organ allograft the organ allograft may be allowed as protocol specific.
6. Patients with evidence or history of bleeding diatheses
7. 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.
8. 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.
9. Patients unable to swallow oral medications
10. Prior use of farnesyl transferase, Raf kinase, or MEK inhibitors
11. Investigational drug therapy outside of this trial during or within 4 weeks of study entry
12. Prior exposure to the study drug

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Sorafenib plus Cisplatin and 5-fluorouracil	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)

Primary Outcome Measures

Name	Time	Method
Objective response rate (CR+PR)	January 2009 to May 2011	In the ITT analysis(n=54), the ORR reached 77.8%: one patient (1.9%) experienced CR; 41 (75.9%), PR.

Secondary Outcome Measures

Name	Time	Method
Disease control rate	January 2009 to May 2011	The disease control rate (DCR) was 90.8%.

Trial Locations

Locations (1)

Cancer Center of Sun-Yat Sen University; 🇨🇳 Guangzhou, Guangdong, China