Gem-TABS in Unresectable Pancreatic Carcinoma
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.
|Pancreatic Cancer||Drug: Sodium bicarbonate (g/kg/day) Drug: Gemcitabine (mg/m²)||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase I Study of Oral Sodium Bicarbonate in Patients With Unresectable Pancreatic Carcinoma Treated With Gemcitabine|
- 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 ]
|Study Start Date:||August 2010|
|Study Completion Date:||June 2011|
|Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
|Experimental: Oral sodium bicarbonate and Gemcitabine||
Drug: Sodium bicarbonate (g/kg/day)
Dose Escalation - Level 1: 0.3, Level 2: 0.5, Level 3: 0/7, Level 4: 1.0Drug: Gemcitabine (mg/m²)
Dose Escalation - Level 1: 1000, Level 2: 1000, Level 3: 1000, Level 4: 1000
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01198821
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Gregory Springett, M.D., Ph.D.||H. Lee Moffitt Cancer Center and Research Institute|