An open, randomised, multicentre trial of Tomudex (ZD1694) versus 5-Fluorouracil (5-FU) and Leucovorin (LV) in patients with advanced colorectal carcinoma

ISRCTN	ISRCTN99195212
DOI	https://doi.org/10.1186/ISRCTN99195212
Protocol serial number	COLO2
Sponsor	AstraZeneca Clinical Research Group (UK)
Funder	AstraZeneca

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr - -
Scientific

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Primary study design	Interventional
Study design	Open randomised multicentre trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	An open, randomised, multicentre trial of Tomudex (ZD1694) versus 5-Fluorouracil (5-FU) and Leucovorin (LV) in patients with advanced colorectal carcinoma
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Raltitrexed (Tomudex®), leucovorin, 5-fluorouracil
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/12/2001

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Key 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
Key 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
Date of first enrolment	01/01/2000
Date of final enrolment	31/12/2001

MRC Clinical Trials Unit

London
NW1 2DA
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

11/01/2016: no publications found on PubMed.