drugset / Trial / NCT00193128
Preoperative Therapy With Oxaliplatin/Docetaxel/Capecitabine and Radiation in Resectable Esophagus Cancer
Phase 1/2
Completed
59 enrolled
SCRI Development Innovations, LLC
Aventis Pharmaceuticals · collabSanofi-Synthelabo · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
In this phase I/II trial, we will evaluate a novel combination of chemotherapy, used concurrently with radiation therapy, in the preoperative therapy of locoregional carcinoma of the esophagus and gastroesophageal junction. In the brief phase I portion of this trial, we will determine whether 2 drugs (docetaxel/oxaliplatin) or 3 drugs (docetaxel/oxaliplatin/capecitabine) can be used concurrently with radiation therapy. If the 3-drug regimen is tolerated, the phase II portion will proceed with this regimen. If the 3-drug combination is considered too toxic, the phase II study will proceed with docetaxel/oxaliplatin in combination with radiation therapy.
Timeline
- Start
- 2004-04
- Primary completion
- 2008-02
- Completion
- 2009-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Subject | Docetaxel | Small molecule | 20 mg/m2 | Intravenous |
| Subject | Oxaliplatin | Small molecule | 40 mg/m2 | Intravenous |