drugset / Trial / NCT00819754
A Phase I/II Study of IXO With Bevacizumab in Patients With Metastatic Colorectal Cancer
Phase 1/2
Terminated
23 enrolled
Ottawa Hospital Research Institute
Hoffmann-La Roche · collabOttawa Regional Cancer Foundation · collabPfizer · collabSanofi · collab
NaSingle-groupOpen-labelTreatment
Summary
Triplets of irinotecan, oxaliplatin and infusional 5-fluorouracil(FU)/leucovorin (LV) are associated with high response rates and long survival as first-line treatment for metastatic colorectal cancer (mCRC). The oral fluoropyrimidine, capecitabine, is better tolerated and shows better response rates than 5-FU/LV in metastatic colorectal cancer. A phase I dose-escalation study established dose limiting toxicity (DLT), maximum tolerated dose (MTD) and recommended phase II doses (RPIID) of irinotecan, oxaliplatin and capecitabine. This phase I /II study is to determine dose-limiting toxicities (DLTs), maximum tolerated dose (MTD), phase II recommended dose (RD) of IXO and bevacizumab combination and safety at the RD in an expanded cohort.
Timeline
- Start
- 2003-11
- Primary completion
- 2012-02
- Completion
- 2012-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | — | — |
| Subject | Capecitabine | Small molecule | — | — |
| Subject | Irinotecan | Small molecule | — | — |
| Subject | Oxaliplatin | Small molecule | — | — |