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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Samsung Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01312311
First received: February 21, 2011
Last updated: March 8, 2011
Last verified: March 2011
History of Changes
  Purpose

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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Myung-Ju Ahn / Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01312311     History of Changes
Other Study ID Numbers: 2006-07-005
Study First Received: February 21, 2011
Last Updated: March 8, 2011
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013