Trial information
A Study of Xeloda (Capecitabine) in Combination With Oxaliplatin in Patients With Metastatic Colorectal Cancer.
Status: No longer recruiting
Protocol number: NP18587
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: An open-label study to assess the pharmacokinetic interaction between Xeloda and oxaliplatin in patients with metastatic colorectal cancer.
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. Target sample size is 30.
Study phase: I
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Pharmacokinetics study
Condition: Colorectal Cancer
Intervention type: Drug
Intervention name: capecitabine [Xeloda]
Primary outcome: 1. AUCo-inf of 5 DFUR, and free platinum. Time frame: Cycles 1, 2 and 3 of treatment
Key secondary outcomes: 1. Pharmacokinetic parameters of capecitabine and its metabolites, and free platinum Time frame: Cycles 1, 2 and 3 of treatment
2. AEs, laboratory parameters Time frame: Throughout study
Inclusion criteria:
- adult patients, >=18 years of age;
- adenocarcinoma of colon or rectum, with metastatic or locally advanced disease.
Exclusion criteria:
- previous systemic treatment for advanced or metastatic disease;
- previous treatment with oxaliplatin or Avastin.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: July, 2005
Trial registration date: 07/19/2006
Date last updated: 8/19/2008
Link to trial result
This trial was conducted at the following locations:
Canada
- Hamilton, ON
- Ottawa, ON
- Toronto, ON
