search
Back to results

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

Primary Purpose

Cancer of the Head and Neck, Neoplasms, Head and Neck

Status
Terminated
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
Oxaliplatin
Sponsored by
Nang Kuang Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer of the Head and Neck focused on measuring Oxaliplatin, Head and Neck cancer

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Taipei Mackay Memorial Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Oxaliplatin/5-FU

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Safety
To assess number of participants with adverse events of these treatment regimen

Full Information

First Posted
March 28, 2011
Last Updated
December 9, 2013
Sponsor
Nang Kuang Pharmaceutical Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT01370876
Brief Title
Efficacy and Safety Study of Oxaliplatin/5-FU in Patients With Recurrent or Metastatic Head and Neck Cancer
Official Title
A Phase II Trial Evaluating Efficacy and Safety of Opatin® (Oxaliplatin)/5-FU in Patients With Recurrent or Metastatic Head and Neck Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Terminated
Why Stopped
company policy
Study Start Date
September 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Nang Kuang Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of the Head and Neck, Neoplasms, Head and Neck
Keywords
Oxaliplatin, Head and Neck cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Oxaliplatin/5-FU
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Other Intervention Name(s)
Opatin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Objective response rate
Description
To evaluate the objective response rate of oxaliplatin combined with 5-FU in patients with recurrent or metastatic head and neck cancer
Time Frame
every 12 weeks
Secondary Outcome Measure Information:
Title
Safety
Description
To assess number of participants with adverse events of these treatment regimen
Time Frame
Each patient will be followed for 30 days after the last dose of study medication

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chang Yi Fan, M.D.
Organizational Affiliation
Taipei Mackay Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Mackay Memorial Hospital
City
Taipei
ZIP/Postal Code
104
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs