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

Sponsor
Rabin Medical Center
Study ID
NCT00845884
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

  • Advanced Gastric Cancer

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Docetaxel, Cisplatin, Capecitabine, Bevacizumab — DRUG
    * 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.

Study Details

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.

Key Dates

First listed
Feb 18, 2009
Start date
Feb 28, 2009
Status verified
Feb 2009
Primary completion
Dec 31, 2012
Completion
Dec 31, 2012

Study Design

Enrollment
49 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: AVDCF
    Drug: Docetaxel, Cisplatin, Capecitabine, Bevacizumab

Primary Outcome Measure

response rate [ Time Frame: 2/2009-12/2012 ]

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