Weekly Docetaxel Plus Cisplatin as the First-line Therapy... | NCT01312311

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

NCT01312311

Sponsor

Samsung Medical Center

Status

Unknown status

Last Update Posted

Mar 10, 2011Estimated

Enrollment

51Estimated

Phase

Phase 2

Conditions

Nasopharyngeal Cancer

Interventions

Docetaxel, Cisplatin

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2006

Primary Completion Date

May 2011Estimated

Completion Date

Not provided

First Submitted Date

Feb 21, 2011

First Submission Date that Met QC Criteria

Mar 8, 2011

First Posted Date

Mar 10, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 8, 2011

Last Update Posted Date

Mar 10, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

51Estimated

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Docetaxel, Cisplatin	Drug	Docetaxel 35mg/m2 D1 & D8 Cisplatin 70mg/m2 D1	weekly docetaxel and cisplatin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
objective response rate		6 months after the enrollment of the last patients

Secondary Outcomes

Measure	Description	Time Frame
number of patients with adverse events		simultaneously when the analysis of primary endpoint

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Myung-Ju Ahn, Pf	Contact	82-2-3410-3459		silkahn@skku.edu

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Samsung Medical Center	Recruiting	Seoul		135-710	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D009303	Nasopharyngeal Neoplasms

Ancestor Terms

ID	Term
D010610	Pharyngeal Neoplasms
D010039	Otorhinolaryngologic Neoplasms
D006258	Head and Neck Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077143	Docetaxel
D002945	Cisplatin

Ancestor Terms

ID	Term
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic

Browse Leaves

Not provided

Browse Branches

Not provided