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Weekly Docetaxel Plus Cisplatin as the First-line Therapy for Nasopharyngeal Cancer

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ClinicalTrials.gov Identifier: NCT01312311
Recruitment Status : Unknown
Verified March 2011 by Samsung Medical Center.
Recruitment status was:  Recruiting
First Posted : March 10, 2011
Last Update Posted : March 10, 2011
Sponsor:
Information provided by:
Samsung Medical Center

Brief Summary:
The investigators will evaluate weekly docetaxel plus 3-weekly cisplatin regimen as the first-line therapy for recurrent of metastatic nasophayngeal cancer

Condition or disease Intervention/treatment Phase
Nasopharyngeal Cancer Drug: Docetaxel, Cisplatin Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 51 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Cisplatin Plus Weekly Docetaxel as the First-line Treatment for Recurrent or Metastatic Nasopharyngeal Cancer
Study Start Date : July 2006
Estimated Primary Completion Date : May 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: weekly docetaxel and cisplatin
Docetaxel 35mg/m2 D1 & D8 Cisplatin 70mg/m2 D1 every 3 weeks maxinum 6 cycles
Drug: Docetaxel, Cisplatin
Docetaxel 35mg/m2 D1 & D8 Cisplatin 70mg/m2 D1




Primary Outcome Measures :
  1. objective response rate [ Time Frame: 6 months after the enrollment of the last patients ]

Secondary Outcome Measures :
  1. number of patients with adverse events [ Time Frame: simultaneously when the analysis of primary endpoint ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • histologically confirmed nasopharyngeal cancer
  • chemotherapy or radiotherapy naive (but, including patients completed 6 months before the enrollment)
  • ECOG 0-1
  • at least one measurable lesion

Exclusion Criteria:

  • other cancer
  • pregnat
  • docetaxel hypersentitivity history
  • severe heart or pulmonary disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01312311


Contacts
Contact: Myung-Ju Ahn, Pf 82-2-3410-3459 silkahn@skku.edu

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Myung-Ju Ahn, Pf    822-3410-3459    silkahn@skku.edu   
Sponsors and Collaborators
Samsung Medical Center

Responsible Party: Myung-Ju Ahn / Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01312311     History of Changes
Other Study ID Numbers: 2006-07-005
First Posted: March 10, 2011    Key Record Dates
Last Update Posted: March 10, 2011
Last Verified: March 2011

Keywords provided by Samsung Medical Center:
nasopharyngeal cancer
weekly docetaxel
cisplatin

Additional relevant MeSH terms:
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Docetaxel
Cisplatin
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action