Plain English Summary
Background and study aims
The aim of this phase II study was to evaluate the anticancer activity and sifde effects of paclitaxel and capecitabine, a chemotherapy regimen (sequence of medicines) that does not contain any platins (platinum-containing anticancer drugs), in patients with recurring or spreading cancer in the head and neck. People with this cancer have generally poor outcomes - when this study was started patients with this condition could in average only hope to live for 6-8 months. The most common regimen at that time was a combination of the two drugs cisplatin and 5-FU. That was the standard offer to our patients as well, but as it is also a very toxic drug combination, especially to these often very fragile patients, we were looking for a drug combination that is less toxic and as effective or more effective against cancer. A combination of paclitaxel and capecitabine produced fewer or less serious side effects in breast cancer patients, so we thought it could be interesting to test this regimen in head and neck cancer patients.
Who can participate?
Men or women aged 18-75 years with recurring or spreading head and neck cancer that can not be treated with surgery or radiotherapy.
What does the study involve?
All patients received paclitaxel via a vein and capecitabine by mouth, with each treatment cycle involving 14 days of treatment and 7 days with no treatment.
What are the possible benefits and risks of participating?
Treatment might extend life. The medicines might cause side effects.
Where is the study run from?
Department of Oncology, Herlev Hospital, Denmark.
When is the study starting and how long is it expected to run for?
The study ran from September 2000 to December 2008.
Who is funding the study?
The study was funded by the trial investigators.
Who is the main contact?
Dr Jens Bentzen, jeben@regionh.dk.
Trial website
Contact information
Type
Scientific
Primary contact
Dr jens bentzen
ORCID ID
Contact details
Department of oncology
Herlev Hospital
Herlev
2730
Denmark
+45 38682188
jeben@regionh.dk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HH 0310
Study information
Scientific title
Phase II analysis of paclitaxel and capecitabine in the treatment of recurrent or disseminated squamous cell carcinoma of the head and neck region
Acronym
Study hypothesis
The aim of this phase II study was to evaluate the antitumor activity and toxicity of a non-platin-containing regimen with paclitaxel and capecitabine for patients with disseminated or recurrent head and neck cancer
Ethics approval
The study was approved by the Ethics Committees of Copenhagen, 23/07/1999, (KF) 02-046/99
Study design
Non-randomised trial
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Recurrent or disseminated squamous cell carcinoma of the head and neck
Intervention
The treatment plan was as follows:
Day 1: Paclitaxel 175 mg/m2 iv over 3 h
Days 1 to 14: Capecitabine 825 mg/m2 per dose orally bid (twice daily) for 2 weeks, with 200 ml water taken <30 min after a meal
After a 1-week interval without medication, the treatment was repeated. The patients received
the following iv premedication 30 min before administration of paclitaxel: dexamethasone
10 mg, clemastine 2 mg, and nizatidine 100 mg.
Intervention type
Drug
Phase
Phase II
Drug names
Paclitaxel and capecitabine
Primary outcome measure
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).
2. Toxicity was measured by blood samples and patient interview after every treatment.
Secondary outcome measures
1. Overall survival was measured from the day chemotherapy started until death.
2. Compliance was measured as number of treatment cycles given at 100% dose and number of treatments given without toxicity-related delay.
Overall trial start date
01/09/2000
Overall trial end date
31/12/2008
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
The study aimed to treat 50 patients in order to evaluate response rates and toxicity for the two-drug combination. As the study result was promising, an additional 133 patient were enrolled.
Participant exclusion criteria
1. Non-measurable disease
2. Pregnant or breastfeeding women
3. Chemotherapy within the last month
4. Brain metastases
5. Other malignant disease
Recruitment start date
01/09/2000
Recruitment end date
31/12/2008
Locations
Countries of recruitment
Denmark
Trial participating centre
Department of Oncology, Herlev Hospital, Denmark.
Herlev
2730
Denmark
Trial participating centre
Department of Oncology, The Finsen Centre, Rigshospitalet
Copenhagen
2100
Denmark
Trial participating centre
Department of Oncology, Aarhus University Hospital, Denmark.
Aarhus
8000
Denmark
Funders
Funder type
Not defined
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The results based on the first 50 patients included were published in 2007 (HEAD & NECK—DOI 10.1002/hed January 2007). The extended study included 183 patients. The final results are now ready for publication and the paper has been submitted.
IPD sharing statement
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.
Intention to publish date
Participant level data
Other
Basic results (scientific)
50 patients with recurrent or disseminated squamous cell carcinoma were included in the study. The treatment consisted of paclitaxel 175 mg/m2 once every third week and capecitabine 825 mg/m2 per oral (p.o.) twice daily (bid) for 2 weeks.Results. The overall response rate according to the World Health Organization (WHO) criteria was 42%. Two patients had a complete response (CR), 19 patients had a partial response (PR), 14 patients had no change (NC), 12 patients had progressive disease (PD), and 3 patients were not evaluable (NE). The median survival time was 8 months. Toxicity was very moderate.
Only 10% of 315 delivered treatments had to be given in reduced dose or postponed for a week or more.
Conclusions. The toxicity was low and manageable. The overall response rate was comparable to the commonly used cisplatin/5-fluorouracil regimen.
As the outcome was rather promising it was decided to accrue more patients, and we ended up including 183 patients.
Publication list
2007 results from first 50 patients in https://www.ncbi.nlm.nih.gov/pubmed/17103405