NCT01198821

Gem-TABS in Unresectable Pancreatic Carcinoma

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Sodium bicarbonate (g/kg/day)	Dose Escalation - Level 1: 0.3, Level 2: 0.5, Level 3: 0/7, Level 4: 1.0
DRUG	Gemcitabine (mg/m²)	Dose Escalation - Level 1: 1000, Level 2: 1000, Level 3: 1000, Level 4: 1000

Timeline

• Start date: 2010-08-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2010-09-10
• Last updated: 2017-02-23

Locations

1 site across 1 country: United States