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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Dose Escalation - Level 1: 0.3, Level 2: 0.5, Level 3: 0/7, Level 4: 1.0
Dose Escalation - Level 1: 1000, Level 2: 1000, Level 3: 1000, Level 4: 1000
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Establish the safety and tolerability of oral sodium bicarbonate in patients with advanced pancreatic carcinoma treated with gemcitabine
Time frame: Average of 6 months
Determine if oral bicarbonate improves overall survival, progression free-survival and response rate in patients with advanced pancreatic cancer
Time frame: Average of 6 months
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