NCT00845884

Phase I/II Study of Weekly Docetaxel and Cisplatin Together With Capecitabine and Bevacizumab in Advanced Gastric Cancer

A Phase I/II Study Evaluating the Combination of Weekly Docetaxel and Cisplatin Together With Capecitabine and Bevacizumab in Patients With Advanced Gastric Cancer

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 49 (estimated)
• Sponsor: Rabin Medical Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Gastric Cancer

Interventions

Type	Name	Description
DRUG	Docetaxel, Cisplatin, Capecitabine, Bevacizumab	* Docetaxel 30-35 mg/m2 IV, on Days 1 and 8, Q:21 days. * Cisplatin 30-35 mg/m2 IV, on Days 1 and 8, Q:21 days. * Capecitabine 1,600 mg/m2/d PO, divided into two daily doses, on Days 1-14, Q:21 days. * Bevacizumab 7.5 mg/kg IV, on Day 1, Q:21 days.

Timeline

• Start date: 2009-02-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2009-02-18
• Last updated: 2009-02-18

Locations

1 site across 1 country: Israel