drugset / Trial / NCT00212615
XELOX III. Xeloda in Combination With Eloxatin for Patients With Advanced or Metastatic Colorectal Cancer
RandomizedFactorialOpen-labelTreatment
Summary
XELOX (Capecitabine and Oxaliplatin) is an effective and convenient regimen for patients with metastatic colorectal cancer. Chronomodulated therapy may reduce toxicity. Patients will be randomized to standard XELOX (Capecitabine 1000 mg/m² in the morning and 1000 mg/m² in the evening days 1-14 and short term Oxaliplatin 130 mg/m² day 1 in 30 minutes) or chronomodulated XELOX (Capecitabine 400 mg/m² in the morning and 1600 mg/m² in the evening days 1-14 and short term Oxaliplatin 130 mg/m² day 1 in 30 minutes). Bloodsamples will be collected and frozen and later examined for potential predictive factors
Timeline
- Start
- 2004-02
- Primary completion
- 2008-10
- Completion
- 2008-10
Publications
- Background Pfeiffer P, Hahn P, Jensen HA. Short-time infusion of oxaliplatin (Eloxatin) in combination with capecitabine (Xeloda) in patients with advanced colorectal cancer. Acta Oncol. 2003;42(8):832-6. doi: 10.1080/02841860310015894.
- Boisen MK, Johansen JS, Dehlendorff C, Larsen JS, Osterlind K, Hansen J, Nielsen SE, Pfeiffer P, Tarpgaard LS, Hollander NH, Keldsen N, Hansen TF, Jensen BB, Jensen BV. Primary tumor location and bevacizumab effectiveness in patients with metastatic colorectal cancer. Ann Oncol. 2013 Oct;24(10):2554-2559. doi: 10.1093/annonc/mdt253. Epub 2013 Jul 17.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Capecitabine | Small molecule | 400 mg/m2 | — |
| Comparator | Capecitabine | Small molecule | 1000 mg/m2 | — |
| Comparator | Capecitabine | Small molecule | 1600 mg/m2 | — |
| Comparator | Oxaliplatin | Small molecule | 130 mg/m2 | — |
Indications
No indication recorded.