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


Phase 2
20 Years
75 Years
Open (Enrolling)
Male
Cancer of the Head and Neck, Neoplasms, Head and Neck

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rate

Outcome Description:

To evaluate the objective response rate of oxaliplatin combined with 5-FU in patients with recurrent or metastatic head and neck cancer

Outcome Time Frame:

every 12 weeks

Safety Issue:

No

Principal Investigator

Chang Yi Fan, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Taipei Mackay Memorial Hospital

Authority:

Taiwan : Food and Drug Administration

Study ID:

10CT006A

NCT ID:

NCT01370876

Start Date:

September 2010

Completion Date:

May 2012

Related Keywords:

  • Cancer of the Head and Neck
  • Neoplasms, Head and Neck
  • Oxaliplatin
  • Head and Neck cancer
  • Neoplasms
  • Head and Neck Neoplasms

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