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

Cancer of the Head and Neck Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01370876
• Other study ID #: 10CT006A
• Status: Terminated
• Phase: Phase 2
• First received: March 28, 2011
• Last updated: December 9, 2013
• Start date: September 2010
• Est. completion date: May 2012

Study information

• Verified date: December 2013
• Source: Nang Kuang Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan : Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 46
• Est. completion date: May 2012
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 75 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Oxaliplatin
Oxaliplatin will be administered as a 2-hour infusion first on Day 1, followed by 5-FU i.v. infusion for 48 hours (Day 1 and Day 2), repeated every 2 weeks, 4 weeks as a cycle.

Locations

Country	Name	City	State
Taiwan	Taipei Mackay Memorial Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Nang Kuang Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate	To evaluate the objective response rate of oxaliplatin combined with 5-FU in patients with recurrent or metastatic head and neck cancer	every 12 weeks	No
Secondary	Safety	To assess number of participants with adverse events of these treatment regimen	Each patient will be followed for 30 days after the last dose of study medication	Yes