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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)
This study is not yet open for participant recruitment.
Verified by Sun Yat-sen University, August 2008
Sponsored by: Sun Yat-sen University
Information provided by: Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT00747799
  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 Disease Control Rate (CR+PR+SD), objective response, safety profile, tolerability will be evaluated according to WHO criteria.


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

MedlinePlus related topics: Cancer
Drug Information available for: Cisplatin Sorafenib Sorafenib tosylate Fluorouracil
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
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)

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

Primary Outcome Measures:
  • disease control rate (CR+PR+SD) [ Time Frame: Aug 2010 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • objective response [ Time Frame: Aug 2010 ] [ Designated as safety issue: No ]

Estimated Enrollment: 53
Study Start Date: September 2008
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
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)
Drug: Sorafenib plus Cisplatin and 5-fluorouracil

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)

  • Sorafenib 400 mg bid per daily . Every 21-day cycles.
  • Cisplatin 20mg/m2 day d1-5, every 21 days cycle.
  • 5-fluorouracil 1000mg/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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00747799

Contacts
Contact: Li Zhang, MD 86-20-87343458 zhangli6@mail.sysu.edu.cn

Locations
China, GuangDong
Cancer Center of Sun-Yat Sen University
Guangzhou, GuangDong, China, 510000
Sponsors and Collaborators
Sun Yat-sen University
  More Information

Responsible Party: Cancer Center of Sun Yat-sen University ( Cancer Center of Sun Yat-sen University )
Study ID Numbers: BAY43-9006-2008003
Study First Received: September 4, 2008
Last Updated: September 5, 2008
ClinicalTrials.gov Identifier: NCT00747799  
Health Authority: China: State Food and Drug Administration

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

Study placed in the following topic categories:
Otorhinolaryngologic Neoplasms
Otorhinolaryngologic Diseases
Pharyngeal Neoplasms
Pharyngeal Diseases
Nasopharyngeal Neoplasms
Recurrence
Carcinoma
Nasopharyngeal carcinoma
Cisplatin
Head and Neck Neoplasms
Fluorouracil
Stomatognathic Diseases
Sorafenib

Additional relevant MeSH terms:
Antimetabolites
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Protein Kinase Inhibitors
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses
Nasopharyngeal Diseases

ClinicalTrials.gov processed this record on January 14, 2009