Chemotherapy with paclitaxel and capecitabine for the treatment of recurrent or metastatic head and neck cancer
| ISRCTN | ISRCTN14555104 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14555104 |
| Secondary identifying numbers | HH 0310 |
- Submission date
- 22/03/2018
- Registration date
- 06/04/2018
- Last edited
- 01/04/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
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.
Contact information
Scientific
Department of oncology, Herlev Hospital
Herlev
2730
Denmark
| Phone | +45 38682188 |
|---|---|
| jeben@regionh.dk |
Study information
| Study design | Non-randomised trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | ISRCTN14555104_PIS_Danish.doc |
| 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 |
| Study objectives | 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(s) | The study was approved by the Ethics Committees of Copenhagen, 23/07/1999, (KF) 02-046/99 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/09/2000 |
| Completion date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | 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. |
| Key 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 |
| Key exclusion criteria | 1. Non-measurable disease 2. Pregnant or breastfeeding women 3. Chemotherapy within the last month 4. Brain metastases 5. Other malignant disease |
| Date of first enrolment | 01/09/2000 |
| Date of final enrolment | 31/12/2008 |
Locations
Countries of recruitment
- Denmark
Study participating centres
2730
Denmark
2100
Denmark
8000
Denmark
Sponsor information
Hospital/treatment centre
Herlev Ringvej 75
Herlev
2730
Denmark
"ROR" |
https://ror.org/00wys9y90 |
|---|
Funders
Funder type
Not defined
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| 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 plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results from first 50 patients | 01/01/2007 | Yes | No | |
| Participant information sheet | 01/04/2019 | No | Yes |
Additional files
- ISRCTN14555104_PIS_Danish.doc
- Uploaded 01/04/2019
Editorial Notes
01/04/2019: The participant information sheet has been uploaded.
