Efficacy and Safety Study of Oxaliplatin/5-FU in Patients... | NCT01370876

Studies
Efficacy and Safety Study of Oxaliplatin/5-FU in Patients With Recurrent or Metastatic Head and Neck Cancer

NCT01370876

Sponsor

Nang Kuang Pharmaceutical Co., Ltd.

Status

Terminated

Last Update Posted

Dec 10, 2013Estimated

Enrollment

46Estimated

Phase

Phase 2

Conditions

Cancer of the Head and Neck
Neoplasms, Head and Neck

Interventions

Oxaliplatin

Countries

Taiwan

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

Dec 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

company policy

Expanded Access Info

Start Date

Sep 2010

Primary Completion Date

Aug 2011Actual

Completion Date

May 2012Actual

First Submitted Date

Mar 28, 2011

First Submission Date that Met QC Criteria

Jun 9, 2011

First Posted Date

Jun 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

Dec 9, 2013

Last Update Posted Date

Dec 10, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

To evaluate the objective response rate of oxaliplatin combined with 5-FU in patients with recurrent or metastatic head and neck cancer and to assess the safety profile of these treatment regimen.

Detailed Description

To evaluate the objective response rate of oxaliplatin combined with 5-FU in patients with recurrent or metastatic head and neck cancer.

To assess the safety profile of these treatment regimen. To evaluate the duration of response of oxaliplatin/5-FU.

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

46Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Oxaliplatin/5-FU	Experimental		Drug: Oxaliplatin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oxaliplatin	Drug	Oxaliplatin will be administered as a 2-hour infusion first on Day 1, followed by 5-FU i.v. infusion for 48 hours (Day 1 and Day 2), repeated every 2 weeks, 4 weeks as a cycle.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Objective response rate	To evaluate the objective response rate of oxaliplatin combined with 5-FU in patients with recurrent or metastatic head and neck cancer	every 12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Safety	To assess number of participants with adverse events of these treatment regimen	Each patient will be followed for 30 days after the last dose of study medication

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients must have been histologically confirmed squamous cell carcinoma of the head and neck (SCCHN) except nasopharyngeal cancer.
Patients must have recurrent or metastatic disease and for which curative surgery or radiotherapy do not exist or are no longer effective.
Prior to entering the protocol treatment, it has to be more than 6 months interval between previous systemic chemotherapy and protocol treatment.
The disease must have been measurable by computed tomographic (CT) scan or MRI (done within 30 days of study entry) and the diameter of the target tumor is at least more than 1 cm.
Patients must be 20 years of age and 75 years of age.
Patients must have an ECOG performance status score 2.
Patient's hematologic function, liver function and renal function must meet the eligibility requirements.
Patients must sign the informed consent.

Exclusion Criteria:

Patients with known hypersensitivity history to Platinum compounds or to 5-Fluorouracil.
Patients with brain metastases.
Patients with bone metastases only.
Patients with pregnancy or breast-feeding.
Patient with CTC (NCI Common Toxicity Criteria) grade 2 peripheral neuropathy of any cause that is clinically detectable.
Patients who have serious concomitant illness that might be aggravated by chemotherapy and other conditions which will be judged by physician's discretion.
Patients who are receiving other anticancer cancer drug(s) for SCCHN.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D056831	Coordination Complexes
D009930	Organic Chemicals

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms