Ignite Creation Date:
2024-05-05 @ 10:48 PM
Last Modification Date:
2024-10-26 @ 10:24 AM
Study NCT ID:
NCT01198821
Status:
COMPLETED
Last Update Posted:
2017-02-23
First Post:
2010-09-09
Brief Title:
Gem-TABS in Unresectable Pancreatic Carcinoma
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
A Phase I Study of Oral Sodium Bicarbonate in Patients With Unresectable Pancreatic Carcinoma Treated With Gemcitabine
Status:
COMPLETED
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 mgm2 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 13 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
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 13 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None