drugset / Trial / NCT00226941
A Phase 1-2 Trial of Cetuximab in Combination With Oxaliplatin, Capecitabine, and Radiation Therapy Followed by Surgery for Locally-advanced Rectal Cancer
RandomizedSequentialOpen-labelTreatment
Summary
The objectives of this study are to: 1. To assess dose-limiting toxicities (DLTs) of capecitabine +/- oxaliplatin in a combination regimen with capecitabine and radiotherapy (Phase 1) 2. To determine the maximum-tolerated dose (MTD) when capecitabine * oxaliplatin in a combination regimen with capecitabine and radiotherapy (Phase 1) 3. To determine the pathologic response rate of cetuximab +/- oxaliplatin in combination with capecitabine and radiotherapy (Phase 2)
Timeline
- Start
- 2004-06
- Primary completion
- 2008-03
- Completion
- 2009-02
Outcome
Outcome not reported
Stopped: “The response rate observed in the phase 1 portion of the study did not merit further evaluation in phase 2 portion of the study.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | 700 mg/m2 | — |
| Subject | Capecitabine | Small molecule | 800 mg/m2 | — |
| Subject | Capecitabine | Small molecule | 1000 mg/m2 | — |
| Subject | Cetuximab | Monoclonal antibody | 250 mg/m2 | Intravenous |
| Subject | Oxaliplatin | Small molecule | 85 mg/m2 | — |
| Subject | Oxaliplatin | Small molecule | 100 mg/m2 | — |
| Background | Diphenhydramine hydrochloride (HCl) | Unknown | 50 mg | — |