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

Phase 2

Terminated

• Conditions: Neoplasms, Head and Neck; Cancer of the Head and Neck
• Interventions: Drug: Oxaliplatin

• Registration Number: NCT01370876
• Lead Sponsor: Nang Kuang Pharmaceutical Co., Ltd.

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.

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2011-03-28
• Study First Submitted QC: 2011-06-09
• Study First Posted: 2011-06-10
• Primary Completion: 2011-08
• Study Completion: 2012-05
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-09
• Last Update Posted: 2013-12-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 46

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Oxaliplatin/5-FU	Oxaliplatin	-

Primary Outcome Measures

Name	Time	Method
Objective response rate	every 12 weeks	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

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

Trial Locations

Locations (1)

Taipei Mackay Memorial Hospital; 🇨🇳 Taipei, Taiwan