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

Sponsor
Nang Kuang Pharmaceutical Co., Ltd. (Industry)
Overall Status
Terminated
CT.gov ID
NCT01370876
Collaborator
(none)
46
Enrollment
1
Location
1
Arm
20
Duration (Months)
2.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
46 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (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
Study Start Date :
Sep 1, 2010
Actual Primary Completion Date :
Aug 1, 2011
Actual Study Completion Date :
May 1, 2012

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • Opatin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Objective response rate [every 12 weeks]

      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

    1. Safety [Each patient will be followed for 30 days after the last dose of study medication]

      To assess number of participants with adverse events of these treatment regimen

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 75 Years
    Sexes Eligible for Study:
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01370876
    Other Study ID Numbers:
    • 10CT006A
    First Posted:
    Jun 10, 2011
    Last Update Posted:
    Dec 10, 2013
    Last Verified:
    Dec 1, 2013
    Keywords provided by , ,
    Oxaliplatin
    Head and Neck cancer
    Additional relevant MeSH terms:
    Head and Neck Neoplasms
    Oxaliplatin

    Study Results

    No Results Posted as of Dec 10, 2013