Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Tegafur, Uracil
UFT · 1 trial · 1 indication
Patients will receive triphasic CT scans at 8 weekly intervals after treatment has started. Patients remain on trial until disease progression or at the discretion of the Investigator.
| Arm | Type | Description |
|---|---|---|
| Cetuximab plus Irinotecan, Oxaliplatin and UFT | EXPERIMENTAL | Cetuximab plus Irinotecan, Oxaliplatin, UFToral |
| Name | Type | Description |
|---|---|---|
| Cetuximab | DRUG | Cetuximab will be prepared under Good Manufacturing practice (GMP) and supplied by Merck KGaA (Darmstadt, Germany) as a solution for intravenous infusion. It will be made up into 250ml with N/Saline. Dose administered is 400mg/m2 and will be given on day 1 and day 15 of a 28 day cycle.Cetuximab will always be administered first, i.e. the cetuximab infusion should be completed one hour before any chemotherapy begins. The cetuximab dose must always be based on the body surface area(BSA). There is no restriction for cetuximab in patients with a BSA \> 2 m2 . |
| Irinotecan | DRUG | Dose is 180mg/m2 made up into 250ml with 5% dextrose or 0.9% saline. It will be administered as a short infusion over 60-90 minutes after a 60 minute gap left after cetuximab administration. Irinotecan is administered on day 1 of the 28 day cycle. |
| Oxaliplatin | DRUG | Dose is 100mg/m2 and will be made up into 250ml with 5% dextrose. It will be administered as a short infusion over 120 minutes after the 60 minute gap left after cetuximab administration. Oxaliplatin is administered on day 15 of the 28 day cycle. |
| UFT | DRUG | UFT dose is 250mg/m2 and is given in three divided doses with calcium folate 30mg p.o. tds on days 1-21 of the 28 day cycle. The highest dose of UFT should be given in the morning if the dose cannot be divided equally. |
Inclusion Criteria: * Histologically confirmed adenocarcinoma of the colon or rectum. * Patients must not have a mutation of K-ras * Inoperable metastatic or locoregional disease (synchronous or recurrence) * No previous chemotherapy for established metastatic disease (adjuvant chemotherapy must ha...
Top 20 of 79 competitors