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UFOX+ Cetuximab · 1 trial · 1 indication
Duration from randomization until progression or death due to any cause. Only deaths within 12 weeks of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment. Response and progression were assessed by the Investigators using response evaluation criteria in solid tumors (RECIST) 1.0 criteria
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | UFOX + Cetuximab |
| 2 | ACTIVE_COMPARATOR | FOLFOX4 + Cetuximab |
| Name | Type | Description |
|---|---|---|
| UFOX + Cetuximab | DRUG | * Cetuximab infusion (400 mg/m\^2 on day 1 of cycle 1 and 250 mg/m\^2 at each subsequent day 1, as well as on days 8, 15 and 22) * Oxaliplatin infusion (85mg/m\^2) on days 1 and 15 (every 2 weeks) * Oral UFT® (250mg/m\^2 tegafur + 560 mg/m\^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21 * Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21 |
| FOLFOX4 + Cetuximab | DRUG | * Cetuximab infusion (400 mg/m\^2 on day 1 of cycle 1 and 250 mg/m\^2 at each subsequent day 1, as well as on days 8, 15 and 22) * Oxaliplatin infusion (85 mg/m\^2) on days 1 and 15 (every 2 weeks) * 5-FU bolus + infusions (400 mg/m\^2) on days 1, 2, 15 and 16 * Folinic Acid infusions (200 mg/m\^2) on days 1, 2, 15 and 16 |
Inclusion Criteria * Signed written informed consent * Inpatient or outpatient ≥ 18 years of age * Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum * First occurrence of metastatic disease (not curatively resectable) * Presence of at least one lesion measurable uni dimens...
UFOX+ Cetuximab is an investigational combination regimen studied in previously untreated metastatic colorectal cancer. It pairs the UFOX chemotherapy backbone with cetuximab and was evaluated in a Phase 2 trial of 302 patients across multiple countries. It is not an approved product and remains in clinical development.
UFOX+ Cetuximab is being developed by Merck KGaA, which trades under the ticker MKGAF. The company sponsored the Phase 2 study evaluating the regimen in previously untreated metastatic colorectal cancer.
UFOX+ Cetuximab is in Phase 2 development. One Phase 2 trial has been completed, and no trials are currently active. The regimen is investigational and has not been approved for any indication.
UFOX+ Cetuximab was studied in NCT00439517, a completed Phase 2 trial titled Study to Evaluate the Efficacy and Safety of FOLFOX-4 Plus Cetuximab Versus UFOX Plus Cetuximab. The trial enrolled 302 patients with previously untreated metastatic colorectal cancer across 13 countries and used an active-controlled, randomized design.