A Research Trial of High Dose Vitamin C and Chemotherapy for Metastatic Pancreatic Cancer
|Pancreatic Neoplasms||Drug: Gemcitabine with escalating ascorbic acid||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||A Phase I Trial of Ascorbic Acid and Gemcitabine for the Treatment of Metastatic Pancreatic Cancer|
- 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 ]
|Study Start Date:||December 2009|
|Study Completion Date:||March 2013|
|Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
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.
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01049880
|United States, Iowa|
|The University of Iowa Hospitals & Clinics|
|Iowa City, Iowa, United States, 52242|
|Principal Investigator:||Joseph J Cullen, M.D.||The University of Iowa|