Condition category
Cancer
Date applied
22/03/2018
Date assigned
06/04/2018
Last edited
05/04/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Sponsor information

Organisation

Department of Oncology, Herlev Hospital

Sponsor details

Herlev Ringvej 75
Herlev
2730
Denmark

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes