Gem-TABS in Unresectable Pancreatic Carcinoma



Status:Archived
Conditions:Cancer, Cancer, Pancreatic Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:August 2010
End Date:October 2013

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Trial Summary
Trial Overview
Inclusion Criteria

A Phase I Study of Oral Sodium Bicarbonate in Patients With Unresectable Pancreatic Carcinoma Treated With Gemcitabine


The purpose of this study is to:

Find out the largest dose of sodium bicarbonate that can be given with gemcitabine.

Determine if the combination of sodium bicarbonate and gemcitabine produces better control
of pancreatic cancer than gemcitabine alone.


Gemcitabine will be administered as an intravenous drip over 30 minutes at a dose of 1000
mg/m2 on days 1, 8, and 15 of each cycle followed by a 7-day treatment rest period. No
treatment will be administered on the 4th week of the cycle. Each cycle is 28 days long.

Sodium bicarbonate is commercially available and supplied as tablets and water soluble
powder. It is stable in solid form and does not need refrigeration. The sodium bicarbonate
will be dispensed by the pharmacy in packets containing 1/3 the daily dose. The patient will
be asked to dissolve the powder in water 3 times per day and consume the dose over a period
of about 30 minutes.

Patients will be required to refrain from use of additional buffering agents (antacids)
including sodium bicarbonate, CaCO3, and aluminum hydroxide.


We found this trial at
1
site
H. Lee Moffitt Cancer Center & Research Institute
12902 USF Magnolia Dr
Tampa, Florida 33612
(888) 663-3488
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
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Tampa, FL
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