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Safety and Efficacy Study of Gemcitabine Combined With High Dose Intravenous Vitamin C (HDIVC) for Patients With Metastatic Adenocarcinoma of the Pancreas

This study has been terminated.
(recruiting or enrolling participants has halted prematurely and will not resume)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01654861
First Posted: August 1, 2012
Last Update Posted: May 30, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eastern Regional Medical Center
Results First Submitted: November 26, 2014  
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)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
HDIVC

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.


Participant Flow:   Overall Study
    HDIVC
STARTED   3 
COMPLETED   3 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
HDIVC

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.


Baseline Measures
   HDIVC 
Overall Participants Analyzed 
[Units: Participants]
 3 
Age 
[Units: Years]
Mean (Full Range)
 55 
 (52 to 59) 
Gender 
[Units: Participants]
 
Female   1 
Male   2 
Region of Enrollment 
[Units: Participants]
 
United States   3 


  Outcome Measures
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1.  Primary:   Adverse Events as a Measure of Safety and Tolerability   [ Time Frame: Weekly for up to 6 months. ]

2.  Secondary:   Anti-Tumor Response   [ Time Frame: Every 2 months for up to 6 months. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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
e-mail: eiko.klimant@ctca-hope.com



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: May 30, 2016