Chemotherapy with paclitaxel and capecitabine for the treatment of recurrent or metastatic head and neck cancer
Phase 2
Completed
- Conditions
- Recurrent or disseminated squamous cell carcinoma of the head and neckCancerSquamous cell carcinoma of the head and neck
- Registration Number
- ISRCTN14555104
- Lead Sponsor
- Department of Oncology, Herlev Hospital
- Brief Summary
2007 results from first 50 patients in https://www.ncbi.nlm.nih.gov/pubmed/17103405
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 183
Inclusion Criteria
1. Histologically confirmed recurrent or disseminated squamous cell carcinoma of the head and neck region, not suitable for curative radiotherapy or salvage surgery
2. Measurable disease in minimum 2 dimensions
3. Aged 18-75 years
4. World Health Organization (WHO) performance status <=2
5. No previous chemotherapy for 1 month
6. No other severe life-shortening disease or other malignant disease
7. Adequate bone marrow, liver, and renal function
Exclusion Criteria
1. Non-measurable disease
2. Pregnant or breastfeeding women
3. Chemotherapy within the last month
4. Brain metastases
5. Other malignant disease
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 1. Response rate as defined by WHO Handbook for Reporting Results of Cancer Treatment. Patients were only eligible if they had at least one lesion measurable in two dimensions using Ultasound, MRI scan or CT-scan. Lesions were measured at baseline and after every 3 cycles ( every 9th week).<br> 2. Toxicity was measured by blood samples and patient interview after every treatment.<br><br>
- Secondary Outcome Measures
Name Time Method <br> 1. Overall survival was measured from the day chemotherapy started until death.<br> 2. Compliance was measured as number of treatment cycles given at 100% dose and number of treatments given without toxicity-related delay.<br>