Conditions: Colorectal Cancer
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 36
Healthy volunteers: no

Brief summary:
This single arm study will investigate possible pharmacokinetic interactions between Xeloda and oxaliplatin, and assess whether the pharmacokinetics of Xeloda and/or oxaliplatin is influenced by the addition of Avastin. All subjects will provide samples for pharmacokinetic analysis during the first 3 cycles of treatment. In cycles 1 and 2 patients will receive a treatment regimen containing Xeloda (1000mg/m2 bid) and oxaliplatin (130mg/m2 iv) and in cycle 3 Avastin (7.5mg/kg iv) will be added to the regimen. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: Avastin intervention 2: Oxaliplatin intervention 3: capecitabine [Xeloda]
Intervention descriptions: intervention 1: 7.5mg/kg iv (cycle 3 only) intervention 2: 130mg/m2 iv (cycles 1, 2 and 3) intervention 3: 1000mg/m2 po bid (cycles 1, 2 and 3)

Protocol document: