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

This study has been terminated.
(company policy)
Sponsor:
Information provided by:
Nang Kuang Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01370876
First received: March 28, 2011
Last updated: December 9, 2013
Last verified: December 2013
  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.


Condition Intervention Phase
Cancer of the Head and Neck
Neoplasms, Head and Neck
Drug: Oxaliplatin
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Nang Kuang Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • Objective response rate [ Time Frame: every 12 weeks ] [ Designated as safety issue: No ]
    To evaluate the objective response rate of oxaliplatin combined with 5-FU in patients with recurrent or metastatic head and neck cancer


Secondary Outcome Measures:
  • Safety [ Time Frame: Each patient will be followed for 30 days after the last dose of study medication ] [ Designated as safety issue: Yes ]
    To assess number of participants with adverse events of these treatment regimen


Estimated Enrollment: 46
Study Start Date: September 2010
Study Completion Date: May 2012
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oxaliplatin/5-FU 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.
Other Name: Opatin

Detailed 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.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01370876

Locations
Taiwan
Taipei Mackay Memorial Hospital
Taipei, Taiwan, 104
Sponsors and Collaborators
Nang Kuang Pharmaceutical Co., Ltd.
Investigators
Principal Investigator: Chang Yi Fan, M.D. Taipei Mackay Memorial Hospital
  More Information

No publications provided

Responsible Party: Cancer Center, Head and Neck Cancer Team, Taipei Mackay Memorial Hospital
ClinicalTrials.gov Identifier: NCT01370876     History of Changes
Other Study ID Numbers: 10CT006A
Study First Received: March 28, 2011
Last Updated: December 9, 2013
Health Authority: Taiwan : Food and Drug Administration

Keywords provided by Nang Kuang Pharmaceutical Co., Ltd.:
Oxaliplatin
Head and Neck cancer

Additional relevant MeSH terms:
Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Oxaliplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014