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
Secondary identifying numbers COLO2
Submission date
19/08/2002
Registration date
19/08/2002
Last edited
11/01/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
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

Contact information

Dr - -
Scientific

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

Study information

Study designOpen randomised multicentre trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleAn open, randomised, multicentre trial of Tomudex (ZD1694) versus 5-Fluorouracil (5-FU) and Leucovorin (LV) in patients with advanced colorectal carcinoma
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedAdvanced colorectal carcinoma
Intervention1. 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 typeDrug
Pharmaceutical study type(s)
PhasePhase III
Drug / device / biological / vaccine name(s)Raltitrexed (Tomudex®), leucovorin, 5-fluorouracil
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/2000
Completion date31/12/2001

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsNot provided at time of registration
Key inclusion criteria1. 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 criteria1. 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 enrolment01/01/2000
Date of final enrolment31/12/2001

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom

Sponsor information

AstraZeneca Clinical Research Group (UK)
Industry

10 Logie Mill
Beaverbank Office Park
Lovie Green Road
Edinburgh
EH7 4HG
United Kingdom

Website http://www.astrazeneca.co.uk
ROR logo "ROR" https://ror.org/04r9x1a08

Funders

Funder type

Industry

AstraZeneca
Government organisation / For-profit companies (industry)
Alternative name(s)
AstraZeneca PLC, Pearl Therapeutics
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

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