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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Drug: Oxaliplatin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxaliplatin/5-FU<br> | Drug: Oxaliplatin<br>* 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.<br>* Other names: Opatin;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oxaliplatin, Head and Neck cancer