- determine the safety and tolerability of 1.5 g/kg intravenous vitamin C (IVC) over 90-120 minutes given 2-3 times per week to cancer patients during the course of chemotherapy including documentation of side effects and toxicity;
- determine pharmacokinetics by measuring plasma vitamin C and urinary oxalic acid before, during, and after treatment with IVC and chemotherapy;
- identify any cancer types and treatments that might be favorable to combine with IVC if possible; and
- measure quality of life (QoL) and mood monthly throughout the study.
Study Parameters Assessed
- The following were measured at study entry and every 4 weeks:
- Tumor markers
- Complete blood count (CBC)
- Metabolic panel
- C-reactive protein (CRP)
- Physical exam
- Coagulation profile
- Functional Assessment of Cancer Therapy-General (FACT-G) quality of life questionnaire scores; range from 1 to 108
- Profile Mood States-B questionnaire giving Total Mood disturbance score; range from -20 to 100
Primary Outcome Measures
Safety and tolerability of 1.5 g/kg IVC given concurrent to chemotherapy regimens (although not given on the same day) in a heterogeneous advanced disease cancer population via descriptive analysis using quality of life and mood questionnaires and individual case synopsis.
Pre- and post-chemotherapy pharmacokinetics of IVC in humans with advanced cancer via measurement of plasma IVC and urinary oxalate levels before, during, and after treatment.
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