Clinical trial NCT01370876: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Cancer of the Head and Neck
Neoplasms, Head and Neck
Keywords: Oxaliplatin
Head and Neck cancer
Lead sponsor: Nang Kuang Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2011-06-10
Enrollment: 46
Sex: MALE
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Objective response rate
timeFrame: every 12 weeks
Secondary outcomes:
measure: Safety
timeFrame: Each patient will be followed for 30 days after the last dose of study medication
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Mackay Memorial Hospital
Study officials:
affiliation: Taipei Mackay Memorial Hospital
name: Chang Yi Fan, M.D.
role: PRINCIPAL_INVESTIGATOR
References: