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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2011 by Samsung Medical Center.
Recruitment status was:  Recruiting
Information provided by:
Samsung Medical Center Identifier:
First received: February 21, 2011
Last updated: March 8, 2011
Last verified: March 2011
The investigators will evaluate weekly docetaxel plus 3-weekly cisplatin regimen as the first-line therapy for recurrent of metastatic nasophayngeal cancer

Condition Intervention Phase
Nasopharyngeal Cancer Drug: Docetaxel, Cisplatin Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Samsung Medical Center:

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

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

Estimated Enrollment: 51
Study Start Date: July 2006
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01312311

Contact: Myung-Ju Ahn, Pf 82-2-3410-3459

Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Myung-Ju Ahn, Pf    822-3410-3459   
Sponsors and Collaborators
Samsung Medical Center
  More Information

Responsible Party: Myung-Ju Ahn / Professor, Samsung Medical Center Identifier: NCT01312311     History of Changes
Other Study ID Numbers: 2006-07-005
Study First Received: February 21, 2011
Last Updated: March 8, 2011

Keywords provided by Samsung Medical Center:
nasopharyngeal cancer
weekly docetaxel

Additional relevant MeSH terms:
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action processed this record on September 21, 2017