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

Nasopharyngeal Cancer Clinical Trial

Official title:

Phase II Trial of Cisplatin Plus Weekly Docetaxel as the First-line Treatment for Recurrent or Metastatic Nasopharyngeal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01312311
• Other study ID #: 2006-07-005
• Status: Recruiting
• Phase: Phase 2
• First received: February 21, 2011
• Last updated: March 8, 2011
• Start date: July 2006

Study information

• Verified date: March 2011
• Source: Samsung Medical Center
• Contact: Myung-Ju Ahn, Pf
• Phone: 82-2-3410-3459
• Email: silkahn[@]skku.edu
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 51
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nasopharyngeal Cancer
• Nasopharyngeal Neoplasms

Intervention

Drug:
• Docetaxel, Cisplatin
Docetaxel 35mg/m2 D1 & D8 Cisplatin 70mg/m2 D1

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	objective response rate		6 months after the enrollment of the last patients	No
Secondary	number of patients with adverse events		simultaneously when the analysis of primary endpoint	Yes