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A Study of Vitamin C in the Treatment of Liver Cancer to Determine if it is Safe and Effective

This study has been completed.
Information provided by (Responsible Party):
Thomas Jefferson University Identifier:
First received: December 18, 2012
Last updated: January 31, 2017
Last verified: January 2017
This protocol is a phase I/II, study of ascorbic acid (AA) infusions combined with treatment with sorafenib versus treatment with sorafenib alone in subjects with metastatic hepatocellular carcinoma. The phase I aspect will assess the safety and efficacy of the concurrent treatments and the phase II aspect will utilize CT (computer-tomography) scans to assess overall tumor response rate and evaluate disease progression

Condition Intervention Phase
Metastatic Hepatocellular Carcinoma
Advanced Liver Cancer
Drug: Ascorbic Acid + Sorafenib
Drug: Sorafenib
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Phase I/II Study of Intravenous Ascorbic Acid in Treatment of Metastatic Hepatocellular Carcinoma

Resource links provided by NLM:

Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:
  • Safety [ Time Frame: 16 weeks +/- 2 weeks ]
    The primary aim is to assess whether or not (IV) Ascorbic Acid (AA) with sorafenib therapy is relatively safe and well-tolerated according to Common Terminology Criteria for Adverse Events (CTCAE)v4.0

Secondary Outcome Measures:
  • Efficacy [ Time Frame: 16 weeks +/- 2 weeks ]
    To utilize CT or PET/CT scans to assess overall tumor response rate (complete and partial response) and evaluate disease progression in subjects with advanced metastatic hepatocellular cancer treated with the combination of ascorbic acid and sorafenib versus sorafenib alone.

  • Quality of Life [ Time Frame: 16 weeks +/- 2 weeks ]
    1) To evaluate quality of life using Functional Assessment of Cancer Therapy-General (FACT-G) quality assessment instrument. The FACT-G questionnaire as well as the Patient Reported Outcomes Measurement Information System (PROMIS-29) will be used to assess quality-of-life longitudinally. Quality-of-life scores obtained from the FACT-G and PROMIS-29 will be summarized at multiple time points using means and standard deviations.

  • Survival [ Time Frame: 15 weeks+ ]
    To evaluate duration of tumor response and progression-free survival

Enrollment: 5
Study Start Date: September 2012
Study Completion Date: January 2016
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ascorbic Acid + Sorafenib

Drug: Vitamin C Other Names: Ascorbic Acid, Ascorbate


Vitamin C : 100 grams (infusion) Phase I: 3x a week for 8 weeks Phase II: 3x a week for 16 weeks Sorafenib: taken daily (oral)

Drug: Ascorbic Acid + Sorafenib
Other Names:
  • Vitamin C
  • Ascorbate
Sorafenib alone
Sorafenib: taken daily (oral)
Drug: Sorafenib
Other Name: Nexavar

Detailed Description:
Intravenous Ascorbic Acid (Vitamin C) is a widely used alternative cancer treatment. This trial will study an intravenous Vitamin C treatment for persons with liver cancer that has spread, who are also receiving Sorafenib (a standard cancer drug), to see whether the combination of Vitamin C and Sorafenib is safe and well tolerated. Phase I will involve 6 persons who will receive the Vitamin C for 8 weeks to more specifically assess the safety of getting Vitamin C in combination with Sorafenib. Phase II will be randomized to receive either Vitamin C plus Sorafenib or Sorafenib alone for 16 weeks. If Vitamin C has a beneficial effect on tumour cells, patients may experience a regression of tumor or tumor markers. Additional benefits include scans at no charge to the patient.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age > 18 years
  • Metastatic hepatocellular carcinoma
  • G6PD (glucose-6-phosphate dehydrogenase) status > lower limit of normal
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
  • Laboratory at baseline evaluation for inclusion in the study: creatinine ≤1.5X upper limit (if the creatinine is elevated, but ≤1.5X the ULN, a 24 hour creatinine clearance will be obtained); transaminase (AST/ALT) ≤2.0X upper limit of normal; bilirubin levels ≥ 2 mg/dL; ANC ≥1,500/mm3; Hemoglobin > 8g/dL; platelet ≥ 100,000/mm3
  • Women of childbearing potential will confirm a negative pregnancy test and must practice effective contraception during the study.
  • Willing and able to provide informed consent and participate in the study procedures.

Exclusion Criteria:

  • Patients with evidence of a significant current psychiatric disorder that would prevent completion of the study as determined by the PI will not be allowed to participate.
  • Co-morbid medical condition that would affect survival or tolerance as determined by the PI. This includes patients who have not fully recovered from toxicities associated with prior therapy. It also includes subjects who, as determined by the PI, are at risk of experiencing fluid overload (i.e., congestive heart failure).
  • Patients who currently abuse alcohol or drugs.
  • Patients with known glomerular filtration rate of <60ml/min or with nephrotic range proteinuria.
  • Pregnant or lactating women
  • Enrollment in active clinical trial/ experimental therapy or IND study within the prior 30 days.
  • Contraindication for CT or PET/CT as per the PI.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01754987

United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
Principal Investigator: Daniel A Monti, MD, MBA Thomas Jefferson University
  More Information

Responsible Party: Thomas Jefferson University Identifier: NCT01754987     History of Changes
Other Study ID Numbers: 12D.424
Study First Received: December 18, 2012
Last Updated: January 31, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Thomas Jefferson University:
Malignant Tumor, Tumour
Integrative Medicine
Complementary Medicine
Alternative Medicine Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Growth Substances
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Radiation-Sensitizing Agents
Liver Cancer

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Liver Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Ascorbic Acid
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Growth Substances
Physiological Effects of Drugs
Protein Kinase Inhibitors
Enzyme Inhibitors
Vitamin B Complex
Protective Agents processed this record on April 25, 2017