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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01370876
Other study ID # 10CT006A
Secondary ID
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


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
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