Cancer of the Head and Neck Clinical Trial
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
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.
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. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Taiwan | Taipei Mackay Memorial Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
Nang Kuang Pharmaceutical Co., Ltd. |
Taiwan,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04444869 -
Testing Less Intensive Radiation With Chemotherapy to Treat Low-risk Patients With HPV-positive Oropharyngeal Cancer
|
Phase 2 | |
Terminated |
NCT03297957 -
Fluorescence Imaging in Head and Neck Cancer
|
N/A | |
Completed |
NCT00716157 -
Incidence and Patterns of Nausea/Vomiting With Combined Chemotherapy and Radiation
|
N/A | |
Recruiting |
NCT04880148 -
The Effectiveness of a Thyme and Honey Spray for Oral Toxicities
|
N/A | |
Completed |
NCT01017224 -
DAHANCA 24: Prognostic Value of 18F-FAZA in Head and Neck Squamous Cell Carcinoma (HNSCC)
|
N/A | |
Completed |
NCT00496652 -
DAHANCA 19: The Importance of the EGFr-inhibitor Zalutumumab for the Outcome After Curative Radiotherapy for HNSCC
|
Phase 3 | |
Completed |
NCT00798655 -
Trial of Postoperative Radiation, Cisplatin, and Panitumumab in Locally Advanced Head and Neck Cancer
|
Phase 2 | |
Recruiting |
NCT03620084 -
Effects of Expiratory Muscle Strength Training on Airway Protection and Swallowing in Chronic Dysphagia After Radiation Therapy
|
N/A | |
Completed |
NCT00147472 -
Positronic Emission Tomography (PET) Imaging in Post Radiation Evaluation of Head and Neck Tumours (PET PREVENT Trial)
|
Phase 3 | |
Completed |
NCT02880072 -
Absorption of Orally Ingested Phosphate in Refeeding Syndrome
|
Phase 4 | |
Completed |
NCT01917942 -
Radiotherapy With Humidification in Head And Neck Cancer
|
Phase 3 | |
Recruiting |
NCT04865731 -
Dermaprazole Cream for Radiation Dermatitis in Head and Neck Cancer
|
Phase 2 | |
Completed |
NCT02442336 -
A Web-Based Multimedia Intervention for Head and Neck Cancer Patients
|
N/A | |
Completed |
NCT03102229 -
Real-time Activity Monitoring to Prevent Admissions During RadioTherapy
|
N/A | |
Completed |
NCT00474825 -
Dose Escalation Study of Hyperbaric Oxygen With Radiation and Chemotherapy to Treat Squamous Cell Carcinoma of the Head and Neck
|
Phase 1 | |
Recruiting |
NCT00180921 -
Study of Imatinib (Glivec) in Patients With Adenoid Cystic Carcinoma of the Head and Neck
|
Phase 2 | |
Completed |
NCT01283334 -
A Study of Carboplatin, Cetuximab and RAD001 in Advanced Head and Neck Cancer
|
Phase 1/Phase 2 | |
Recruiting |
NCT02557048 -
Head and Neck Cancer in Children: A Retrospective Study
|
||
Completed |
NCT02073032 -
Incidence and Risk Factors of Refeeding Syndrome
|
N/A | |
Active, not recruiting |
NCT02270814 -
Cisplatin, Nab-Paclitaxel, and Cetuximab (CACTUX) in Patients With Incurable Head and Neck Squamous Cell Carcinoma
|
Phase 2 |