Phase I/II Study of Weekly Docetaxel and Cisplatin Together With Capecitabine and Bevacizumab in Advanced Gastric Cancer
Summary
In spite of multiple attempts to improve the efficacy of first-line chemotherapy in advanced gastric cancer, the progress that has been achieved so far is rather limited, and many investigators are exploring newer regimens.A combination of decetaxel (Taxotere) with Cisplatin and 5-fluorouracil (5FU) is considered one of the most effective regimens in this disease. However, it is associated with significant toxicity which avoided its general adaptation by the medical community. The current study is exploring a newer way to administer these three drugs, hopefully making the regimen more comfortable, less toxic and maybe even more effective. We will do this by changing the dose and timing of Taxotere and Cisplating, by replacing protracted infusion of 5FU with tablets of Capecitabine (Xeloda) and by adding the anti-angiogenic drug, Bevacizumab (Avastin), which had shown encouraging results in this disease.
Timeline
- Start
- 2009-02
- Primary completion
- 2012-12
- Completion
- 2012-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | 7.5 mg/kg | Intravenous |
| Subject | Capecitabine | Small molecule | 1600 mg/m2 | Oral |
| Subject | Cisplatin | Other / unclassified | 30 mg/m2 | Intravenous |
| Subject | Cisplatin | Other / unclassified | 35 mg/m2 | Intravenous |
| Subject | Docetaxel | Small molecule | 30 mg/m2 | Intravenous |
| Subject | Docetaxel | Small molecule | 35 mg/m2 | Intravenous |