A Research Trial of High Dose Vitamin C and Chemotherapy for Metastatic Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT01049880|
Recruitment Status : Completed
First Posted : January 15, 2010
Last Update Posted : April 21, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Neoplasms||Drug: Gemcitabine with escalating ascorbic acid||Phase 1|
This is a phase I, dose-escalating study of ascorbic acid (vitamin C) designed to determine the maximum tolerated dose of vitamin C or, if well tolerated, the dose required to obtain a desired ascorbic acid plasma concentration.
Because this is a phase I study, prospective subjects should have advanced disease (i.e., metastasis) and have failed other curative therapies (or, are unable to receive curative therapies due to comorbidities or stage of disease).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Trial of Ascorbic Acid and Gemcitabine for the Treatment of Metastatic Pancreatic Cancer|
|Study Start Date :||December 2009|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||March 2013|
Drug: Gemcitabine with escalating ascorbic acid
Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off. Ascorbic acid, given twice weekly, escalating doses weekly. Week 1: 15 grams ascorbic acid per infusion Week 2: 25 grams ascorbic acid per infusion Week 3: 50 grams ascorbic acid per infusion Week 4: 75 grams ascorbic acid per infusion Week 5: 100 grams ascorbic acid per infusion
Ascorbic acid infusion dose is maintained at the level that provides a serum level of 350-400 mg/dL.
- Blood cell counts (neutropenia, thrombocytopenia) and serum chemistries (liver function tests, creatinine) [ Time Frame: weekly ]
- Plasma ascorbate level (targeted to 350 to 400 mg/dL) [ Time Frame: Weekly ]
- Survival [ Time Frame: Ongoing ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01049880
|United States, Iowa|
|The University of Iowa Hospitals & Clinics|
|Iowa City, Iowa, United States, 52242|
|Principal Investigator:||Joseph J Cullen, M.D.||University of Iowa|