Efficacy and Safety Study of Oxaliplatin/5-FU in Patients With Recurrent or Metastatic Head and Neck Cancer
This study has been terminated.
Information provided by:
Nang Kuang Pharmaceutical Co., Ltd.
First received: March 28, 2011
Last updated: December 9, 2013
Last verified: December 2013
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.
Cancer of the Head and Neck
Neoplasms, Head and Neck
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Phase II Trial Evaluating Efficacy and Safety of Opatin® (Oxaliplatin)/5-FU in Patients With Recurrent or Metastatic Head and Neck Cancer
Primary Outcome Measures:
Secondary Outcome Measures:
| Estimated Enrollment:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||August 2011 (Final data collection date for primary outcome measure)
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
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.
|Ages Eligible for Study:
||20 Years to 75 Years (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
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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
|Taipei Mackay Memorial Hospital
|Taipei, Taiwan, 104 |
Nang Kuang Pharmaceutical Co., Ltd.
||Chang Yi Fan, M.D.
||Taipei Mackay Memorial Hospital
||Cancer Center, Head and Neck Cancer Team, Taipei Mackay Memorial Hospital
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 28, 2011
||December 9, 2013
||Taiwan : Food and Drug Administration
Keywords provided by Nang Kuang Pharmaceutical Co., Ltd.:
Head and Neck cancer
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 27, 2016
Head and Neck Neoplasms
Neoplasms by Site