Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
LIVERPL-HN1
Study information
Scientific title
A phase II randomised study of cisplatinum and nifedipine in end stage carcinoma of the head and neck
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Head and neck cancer
Intervention
Patients are randomised to one of two treatment regimens:
1. Group A: Cisplatinum repeated every 21 days for a maximum of six cycles
2. Group B: Cisplatinum plus nifedipine repeated every 21 days for a maximum of six cycles
Intervention type
Drug
Phase
Phase II
Drug names
Cisplatinum and nifedipine
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/2003
Overall trial end date
01/01/2004
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients with either advanced squamous cell carcinoma of the head and neck, not previously treated, or recurrent squamous cell carcinoma of the head and neck after previous radiotherapy or surgery
2. Measurable histologically confirmed, squamous cell carcinoma of the head and neck. The primary sites will be:
2.1. Mouth
2.2. Nasopharynx
2.3. Oropharynx
2.4. Hypopharynx
2.5. Larynx
2.6. Nose and sinuses
2.7. Middle ear
3. No prior chemotherapy
4. Not suitable for surgery or radiotherapy with a curative purpose
5. Karnofsky performance greater than 50
6. Minimum of three weeks since prior radiotherapy and or surgery and patients must have fully recovered from such prior treatments
7. Adequate bone marrow and renal function
8. No active infection
9. No concomitant or prior malignancy except adequately treated basal cell carcinoma of the skin and in situ carcinoma of the uterine cervix
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/2003
Recruitment end date
01/01/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
North West Cancer Research Fund (UK)
Sponsor details
22 Oxford Street
Liverpool
L7 7BL
United Kingdom
+44 (0)151709 2919
GenSec@cancerresearchnorthwest.co.uk
Sponsor type
Research organisation
Website
Funders
Funder type
Not defined
Funder name
Not provided at time of registration
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary