None listed
Conditions
Brief summary
The DaVINCI trial closed to recruitment on 31st January 2008. 89 patients were recruited from Australia and New Zealand
Interventions
Irinotecan versus irinotecan + 5-FU/leucovorin.
Duration: Until patients progress
Sponsors
AGITG
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
(1) Metastatic or locally advanced colon or rectal cancer not curable by surgery or other methods. (2) At least one lesion evaluable for response by RECIST criteria. (3) Age = 18 years. (4) Life expectancy of at least 12 weeks. (5) ECOG performance status 0-2. (6) Confirmed progression after one prior chemotherapy regimen for advanced disease or relapse within 6 months of receiving prior adjuvant chemotherapy. (7) Normal haematological tests: haemoglobin >10 g/dL, WBC >4.0 x 109/L, neutrophils > 1.5 x 109/L, platelets >100 x 109/L (8) Normal renal function tests, documented as serum creatinine ? 2.0 x IULN (9) Adequate hepatic function. Bilirubin must be ? 1.5 x IULN for all patients (10) Patients must be geographically accessible and physically capable of completing study investigations as required (11) Written informed consent.
Exclusion criteria
(1) Serious infection or other intercurrent illness which will prevent adequate assessment of response and toxicity. (2) Pregnancy or breast feeding. (3) Previous chemotherapy within 4 weeks of start of trial treatment. (4) Extensive radiotherapy within 4 weeks of start of trial therapy. (5) Cerebral metastases. If the possibility of cerebral metastases is clinically indicated appropriate investigation should be undertaken before the patient is considered for participation in the study. (6) Evidence of Gilbert’s syndrome. (7) Prior treatment with irinotecan.
Outcome results
None listed