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

Nang Kuang Pharmaceutical

Status and phase

Terminated

Phase 2

Conditions

Cancer of the Head and Neck

Neoplasms, Head and Neck

Treatments

Drug: Oxaliplatin

Study type

Interventional

Funder types

Industry

Identifiers

NCT01370876

10CT006A

Details and patient eligibility

About

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.

Full 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.

Enrollment

46 estimated patients

Sex

Male

Ages

20 to 75 years old

Volunteers

No Healthy Volunteers

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.