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

NCT ID: NCT01370876

Last Updated: 2013-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2012-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cancer of the Head and Neck Neoplasms, Head and Neck

Keywords

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Oxaliplatin Head and Neck cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Oxaliplatin/5-FU

Group Type EXPERIMENTAL

Oxaliplatin

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Opatin

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Nang Kuang Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Taipei Mackay Memorial Hospital

Principal Investigators

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Chang Yi Fan, M.D.

Role: PRINCIPAL_INVESTIGATOR

Taipei Mackay Memorial Hospital

Locations

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Taipei Mackay Memorial Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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10CT006A

Identifier Type: -

Identifier Source: org_study_id