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Safety & Efficacy Study of Gemcitabine...With High Dose IV Vit. C (HDIVC)

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ClinicalTrials.gov Identifier: NCT01654861
Recruitment Status : Terminated (recruiting or enrolling participants has halted prematurely and will not resume)
First Posted : August 1, 2012
Results First Posted : December 1, 2014
Last Update Posted : July 25, 2018
Sponsor:
Information provided by (Responsible Party):
Eastern Regional Medical Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Metastatic Adenocarcinoma of the Pancreas
Intervention Drug: Gemcitabine, Intravenous and oral Ascorbic Acid (Vitamin C)
Enrollment 3
Recruitment Details  
Pre-assignment Details  
Arm/Group Title HDIVC
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Gemcitabine (Gemzar), Intravenous and oral Ascorbic Acid (Vitamin C).

Gemcitabine, Intravenous and oral Ascorbic Acid (Vitamin C): Weeks 1,2,3: IV Gemcitabine 1000 mg / m² over 30 minutes followed by HDIVC 1.2 g / kg: 1.2 g/kg over 90 minutes for a dose ≤90 g and over 120 minutes for a dose >90g followed by 0.3 g / kg over 120 minutes; Week 4: no treatment.

Period Title: Overall Study
Started 3
Completed 3
Not Completed 0
Arm/Group Title HDIVC
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Gemcitabine (Gemzar), Intravenous and oral Ascorbic Acid (Vitamin C).

Gemcitabine, Intravenous and oral Ascorbic Acid (Vitamin C): Weeks 1,2,3: IV Gemcitabine 1000 mg / m² over 30 minutes followed by HDIVC 1.2 g / kg: 1.2 g/kg over 90 minutes for a dose ≤90 g and over 120 minutes for a dose >90g followed by 0.3 g / kg over 120 minutes; Week 4: no treatment.

Overall Number of Baseline Participants 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 3 participants
55
(52 to 59)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Female
1
  33.3%
Male
2
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants
3
1.Primary Outcome
Title Adverse Events as a Measure of Safety and Tolerability
Hide Description Adverse events, whether volunteered by the study subject, discovered by the investigators during questioning, or detected by physical examination, laboratory tests, or other means will be collected and recorded at each visit. Events will be recorded from the time the consent is signed until 4 weeks after the study protocol is discontinued. Subjects experiencing Grade 4 neutropenia, Grade ≥3 thrombocytopenia, or Grade 2 peripheral neuropathy who do not recover will have treatment protocol discontinued.
Time Frame Weekly for up to 6 months.
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title HDIVC
Hide Arm/Group Description:

Gemcitabine (Gemzar), Intravenous and oral Ascorbic Acid (Vitamin C).

Gemcitabine, Intravenous and oral Ascorbic Acid (Vitamin C): Weeks 1,2,3: IV Gemcitabine 1000 mg / m² over 30 minutes followed by HDIVC 1.2 g / kg: 1.2 g/kg over 90 minutes for a dose ≤90 g and over 120 minutes for a dose >90g followed by 0.3 g / kg over 120 minutes; Week 4: no treatment.

Overall Number of Participants Analyzed 3
Measure Type: Number
Unit of Measure: participants
0
2.Secondary Outcome
Title Anti-Tumor Response
Hide Description CT and PET scans will be performed at baseline and then every two months. Target and Non-Target Lesions will be identified and recorded at baseline. When subsequent scans are performed, anti-tumor responses will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST).
Time Frame Every 2 months for up to 6 months.
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Hide Analysis Population Description
Data were not analyzed as the study was prematurely closed.
Arm/Group Title HDIVC
Hide Arm/Group Description:

Gemcitabine (Gemzar), Intravenous and oral Ascorbic Acid (Vitamin C).

Gemcitabine, Intravenous and oral Ascorbic Acid (Vitamin C): Weeks 1,2,3: IV Gemcitabine 1000 mg / m² over 30 minutes followed by HDIVC 1.2 g / kg: 1.2 g/kg over 90 minutes for a dose ≤90 g and over 120 minutes for a dose >90g followed by 0.3 g / kg over 120 minutes; Week 4: no treatment.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title HDIVC
Hide Arm/Group Description

Gemcitabine (Gemzar), Intravenous and oral Ascorbic Acid (Vitamin C).

Gemcitabine, Intravenous and oral Ascorbic Acid (Vitamin C): Weeks 1,2,3: IV Gemcitabine 1000 mg / m² over 30 minutes followed by HDIVC 1.2 g / kg: 1.2 g/kg over 90 minutes for a dose ≤90 g and over 120 minutes for a dose >90g followed by 0.3 g / kg over 120 minutes; Week 4: no treatment.

All-Cause Mortality
HDIVC
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
HDIVC
Affected / at Risk (%)
Total   0/3 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
HDIVC
Affected / at Risk (%)
Total   0/3 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Eiko Klimant, MD
Organization: Eastern Regional Medical Center
Phone: 215-537-7400
Responsible Party: Eastern Regional Medical Center
ClinicalTrials.gov Identifier: NCT01654861     History of Changes
Other Study ID Numbers: ERMC 11-11
First Submitted: July 13, 2012
First Posted: August 1, 2012
Results First Submitted: November 26, 2014
Results First Posted: December 1, 2014
Last Update Posted: July 25, 2018