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

NCT00845884 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2009-02-18

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Rabin Medical Center

    lead OTHER

Principal Investigators

  • Baruch Brenner, MD · Davidoff Cancer Center, Rabin Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00845884 on ClinicalTrials.gov