Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
COLO2
Study information
Scientific title
An open, randomised, multicentre trial of Tomudex (ZD1694) versus 5-Fluorouracil (5-FU) and Leucovorin (LV) in patients with advanced colorectal carcinoma
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Open randomised multicentre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Advanced colorectal carcinoma
Intervention
1. Treatment A: Tomudex, a single dose repeated every three weeks until disease progression, unacceptable toxicity or proof of no clinical benefit to the patient.
2. Treatment B: Leucovorin followed by 5-fluorouracil daily for five days, repeated at week four, week eight and every five weeks thereafter until disease progression, unacceptable toxicity or proof of no clinical benefit to the patient.
Intervention type
Drug
Phase
Phase III
Drug names
Raltitrexed (Tomudex®), leucovorin, 5-fluorouracil
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/2000
Overall trial end date
31/12/2001
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Microscopically confirmed adenocarcinoma of the colon or rectum
2. Locally advanced, or metastatic (Dukes stage D) disease for which no curative therapy is available
3. Aged over 18 years
4. One or more measurable or evaluable lesions
5. World Health Organisation (WHO) performance status 0-2
6. Life expectancy of at least three months
7. Adequate bone marrow and liver function
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Not provided at time of registration
Participant exclusion criteria
1. Previous systemic chemotherapy for colorectal cancer
2. Concomitant use of any systemic anticancer therapy
3. Adjuvant chemotherapy within the last 12 months
4. Concomitant administration of folic acid other than the trial therapy
5. Known brain metastases
6. Previous or concurrent malignancies at other sites, except adequately treated in-situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin
7. Other medical contraindications to treatment
Recruitment start date
01/01/2000
Recruitment end date
31/12/2001
Locations
Countries of recruitment
United Kingdom
Trial participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
AstraZeneca Clinical Research Group (UK)
Sponsor details
10 Logie Mill
Beaverbank Office Park
Lovie Green Road
Edinburgh
EH7 4HG
United Kingdom
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
AstraZeneca
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
corporate
Location
United Kingdom
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
Basic results (scientific)
Publication list