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Sponsored by: |
Sun Yat-sen University |
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Information provided by: | Sun Yat-sen University |
ClinicalTrials.gov Identifier: | NCT00747799 |
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 |
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Nasopharyngeal Neoplasms |
Drug: Sorafenib plus Cisplatin and 5-fluorouracil |
Phase II |
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) |
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 |
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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)
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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)
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adequate bone marrow, liver and renal functions as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
Exclusion Criteria:
Contact: Li Zhang, MD | 86-20-87343458 | zhangli6@mail.sysu.edu.cn |
China, GuangDong | |
Cancer Center of Sun-Yat Sen University | |
Guangzhou, GuangDong, China, 510000 |
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 |
recurrent or metastatic Nasopharyngeal Neoplasms |
Otorhinolaryngologic Neoplasms Otorhinolaryngologic Diseases Pharyngeal Neoplasms Pharyngeal Diseases Nasopharyngeal Neoplasms Recurrence Carcinoma |
Nasopharyngeal carcinoma Cisplatin Head and Neck Neoplasms Fluorouracil Stomatognathic Diseases Sorafenib |
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 |