Ignite Creation Date:
2025-12-24 @ 1:00 PM
Ignite Modification Date:
2025-12-31 @ 6:23 AM
Study NCT ID:
NCT01654861
Status:
TERMINATED
Last Update Posted:
2018-07-26
First Post:
2012-07-13
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety & Efficacy Study of Gemcitabine...With High Dose IV Vit. C (HDIVC)
Sponsor:
Eastern Regional Medical Center
Organization:
Study Overview
Official Title:
Evaluation of the Safety and Efficacy of Standard Dose Gemcitabine Combined With High Dose Intravenous Vitamin C (HDIVC) Treatment for Patients With Metastatic Adenocarcinoma of the Pancreas.
Status:
TERMINATED
Status Verified Date:
2018-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
recruiting or enrolling participants has halted prematurely and will not resume
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
* The combination of gemcitabine and HDIVC is safe and may favorably change the clinical course for an individual patient.
* The combination of gemcitabine and HDIVC is synergistic in anti-tumor effect as seen in preclinical models, where HDIVC creates a pro-oxidative effect that adds to the anti-tumor effect of gemcitabine.
* The combination of gemcitabine and HDIVC may improve Progression Free Survival (PFS).
* The dosage schema of 1.2 g /kg bolus infusion followed by lower dose of 0.3 g / kg infusion may create sustained elevation in Vitamin C plasma levels for increased cytotoxic effect.
* The addition of HDIVC \& oral supplementation of Vitamin C to standard treatment with gemcitabine may improve quality of life for patients with comparison to prior to treatment start of this protocol.
* CA 19-9 and inflammatory markers may show trends for patients in this trial.
* The combination of gemcitabine and HDIVC is synergistic in anti-tumor effect as seen in preclinical models, where HDIVC creates a pro-oxidative effect that adds to the anti-tumor effect of gemcitabine.
* The combination of gemcitabine and HDIVC may improve Progression Free Survival (PFS).
* The dosage schema of 1.2 g /kg bolus infusion followed by lower dose of 0.3 g / kg infusion may create sustained elevation in Vitamin C plasma levels for increased cytotoxic effect.
* The addition of HDIVC \& oral supplementation of Vitamin C to standard treatment with gemcitabine may improve quality of life for patients with comparison to prior to treatment start of this protocol.
* CA 19-9 and inflammatory markers may show trends for patients in this trial.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: