Advanced colorectal carcinoma Cancer Malignant neoplasm of other or ill-defined digestive organs
Conditions
Interventions
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 b
Sponsors
AstraZeneca Clinical Research Group (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
United Kingdom
Outcome results
None listed