Safety and Efficacy Study of Gemcitabine Combined With High Dose Intravenous Vitamin C (HDIVC) for Patients With Metastatic Adenocarcinoma of the Pancreas
|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 : May 30, 2016
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Adenocarcinoma of the Pancreas||Drug: Gemcitabine, Intravenous and oral Ascorbic Acid (Vitamin C)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2014|
Gemcitabine (Gemzar), Intravenous and oral Ascorbic Acid (Vitamin C).
Drug: 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.
- Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Weekly for up to 6 months. ]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.
- Anti-Tumor Response [ Time Frame: Every 2 months for up to 6 months. ]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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01654861
|United States, Pennsylvania|
|Eastern Regional Medical Center|
|Philadelphia, Pennsylvania, United States, 19124|
|Principal Investigator:||Eiko Klimant, MD, FACP||Eastern Regional Medical Center|
|Principal Investigator:||Heather Wright, ND, FABNO||Eastern Regional Medical Center|