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

A Phase II Trial Evaluating Efficacy and Safety of Opatin® (Oxaliplatin)/5-FU in Patients With Recurrent or Metastatic Head and Neck Cancer

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.

Study Overview

• Status: Terminated
• Conditions: Neoplasms, Head and Neck; Cancer of the Head and Neck
• Intervention / Treatment: Drug: Oxaliplatin

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.

• Study Type: Interventional
• Enrollment (Anticipated): 46
• Phase: Phase 2

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 104
    • Taipei Mackay Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oxaliplatin/5-FU	Drug: Oxaliplatin; 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.; Other Names: Opatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Nang Kuang Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Chang Yi Fan, M.D., Taipei Mackay Memorial Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: March 28, 2011
• First Submitted That Met QC Criteria: June 9, 2011
• First Posted (Estimate): June 10, 2011

Study Record Updates

• Last Update Posted (Estimate): December 10, 2013
• Last Update Submitted That Met QC Criteria: December 9, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Oxaliplatin; Head and Neck cancer
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Antineoplastic Agents; Oxaliplatin
• Other Study ID Numbers: 10CT006A