Clinical Trial Details

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Study ID 10CT006A
Investigator
Chang Yi Fan, M.D.,   Taipei Mackay Memorial Hospital
Title Efficacy and Safety Study of Oxaliplatin/5-FU in Patients With Recurrent or Metastatic Head and Neck Cancer
Conditions Cancer of the Head and Neck
Neoplasms, Head and Neck
Interventions Drug: Oxaliplatin
Phase Phase 2
Purpose 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.
Eligibility Ages Eligible: 20 Years
Genders Eligible:  Male
Accepts Healthy Volunteers:  No
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 Location
    Contact

    Information objtained from ClinicalTrials.gov, on 10/25/2014. For additional information about this and other clinical trials, visit http://clinicaltrials.gov.
    Please refer to this study by its ClinicalTrials.gov identifier: NCT01370876


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