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Phase II Study of Combination of Sorafenib With Cisplatin and 5-fluorouracil as First-line Treatment of Recurrence After Radiotherapy Patients Who Are Failure of Radiotherapy in Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC)


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Nasopharyngeal Neoplasms

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Trial Information

Phase II Study of Combination of Sorafenib With Cisplatin and 5-fluorouracil as First-line Treatment of Recurrence After Radiotherapy Patients Who Are Failure of Radiotherapy in Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC)


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rate (CR+PR)

Outcome Time Frame:

August 2010

Safety Issue:

No

Principal Investigator

Li Zhang, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sun Yat-sen University

Authority:

China: Food and Drug Administration

Study ID:

BAY43-9006-2008003

NCT ID:

NCT00747799

Start Date:

January 2009

Completion Date:

May 2012

Related Keywords:

  • Nasopharyngeal Neoplasms
  • recurrent or metastatic Nasopharyngeal Neoplasms
  • Neoplasms
  • Carcinoma
  • Nasopharyngeal Neoplasms
  • Recurrence

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