Overview
Efficacy and Safety Study of Oxaliplatin/5-FU in Patients With Recurrent or Metastatic Head and Neck Cancer
Status:
Terminated
Terminated
Trial end date:
2012-05-01
2012-05-01
Target enrollment:
0
0
Participant gender:
Male
Male
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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Nang Kuang Pharmaceutical Co., Ltd.Treatments:
Oxaliplatin
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.