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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Li Zhang, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT00747799
First received: September 4, 2008
Last updated: December 8, 2013
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Nasopharyngeal Neoplasms
Drug: Sorafenib plus Cisplatin and 5-fluorouracil
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • Objective response rate (CR+PR) [ Time Frame: January 2009 to May 2011 ] [ Designated as safety issue: No ]
    In the ITT analysis(n=54), the ORR reached 77.8%: one patient (1.9%) experienced CR; 41 (75.9%), PR.


Secondary Outcome Measures:
  • Disease control rate [ Time Frame: January 2009 to May 2011 ] [ Designated as safety issue: Yes ]
    The disease control rate (DCR) was 90.8%.


Enrollment: 54
Study Start Date: January 2009
Study Completion Date: November 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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)
Drug: 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)

  • Sorafenib 400 mg bid per daily . Every 21-day cycles.
  • Cisplatin 80 mg/m2 day d1, every 21 days cycle.
  • 5-fluorouracil 1000 mg/m2 day CIV 4days, repeat 21-day cycles

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00747799

Locations
China, Guangdong
Cancer Center of Sun-Yat Sen University
Guangzhou, Guangdong, China, 510000
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Principal Investigator: Li Zhang, MD Sun Yat-sen University
  More Information

No publications provided

Responsible Party: Li Zhang, Profressor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT00747799     History of Changes
Other Study ID Numbers: BAY43-9006-2008003
Study First Received: September 4, 2008
Last Updated: December 8, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Sun Yat-sen University:
recurrent or metastatic Nasopharyngeal Neoplasms

Additional relevant MeSH terms:
Neoplasms
Recurrence
Nasopharyngeal Neoplasms
Disease Attributes
Pathologic Processes
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Sorafenib
Cisplatin
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 01, 2014