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Assessing the Efficacy and Safety of IV Vitamin C in Combination With Standard Chemotherapy for Pancreatic Ca

This study has been completed.
Information provided by (Responsible Party):
Thomas Jefferson University Identifier:
First received: February 22, 2012
Last updated: January 31, 2017
Last verified: January 2017
The investigators recently completed a phase I study of intravenous ascorbic acid (IV AA) plus standard chemotherapy (gemcitabine and erlotinib) in patients with metastatic pancreatic cancer. The investigators determined that the target ceiling dosage of 100 grams of ascorbic acid is safe when given with the chemotherapy. This Phase II trial is an initial test of efficacy of the 100 gram dose of ascorbic acid, which will be given with the same standard chemotherapy. This open label study will recruit up to 35 subjects with metastatic pancreatic cancer who will receive ascorbic acid combined with gemcitabine and erlotinib as front-line treatment. The phase I data suggests that ascorbic acid when given in combination with gemcitabine and erlotinib may result in some tumor response, and the goal of this study is to better evaluate the response and confirm initial safety data

Condition Intervention Phase
Stage IV Pancreatic Cancer
Drug: Ascorbic Acid
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Phase II, Open Label Study of Intravenous Ascorbic Acid in Combination With Gemcitabine and Erlotinib in the Treatment of Metastatic Pancreatic Cancer

Resource links provided by NLM:

Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:
  • Safety and Efficacy of ascorbic acid in combination with gemcitabine and erlotinib for stage IV Pancreatic cancer [ Time Frame: 15 weeks ]
    Safety: to assess safety of IVAA in combination with gemcitabine and erlotinib by evaluating the number of adverse events and serious adverse events occurring among study participants. Efficacy: to assess efficacy of IVAA in combination with gemcitabine and erlotinib. Partial response rate and progression free survival at 15 weeks will be assessed using RECIST criteria, and compared to the well-documented rates observed in previously published studies and historical dataset at Jefferson in patients treated with gemcitabine plus erlotinib alone.

Secondary Outcome Measures:
  • quality of life [ Time Frame: 15 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.

Enrollment: 11
Study Start Date: October 2011
Study Completion Date: January 2016
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ascorbic Acid, Gemcitabine & Erlotinib
Ascorbic Acid (50-100g, 3x weekly) Standard Chemotherapy of Gemcitabine and Erlotinib for Pancreatic Cancer
Drug: Ascorbic Acid
3x per week
Other Names:
  • Vitamin C
  • Ascorbate

Detailed Description:
Intravenous high dose ascorbic acid is a widely used alternative cancer treatment. Patients will receive standard care gemcitabine/erlotinib for treatment of their metastatic pancreatic adenocarcinoma. They will be closely monitored for disease response/ progression. 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. This study requires several days of treatment per week and treatments are given in two different locations. The intravenous vitamin C treatments are given 3 times per week, these are given every week for an initial cycle of 15 weeks.

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

Inclusion Criteria:

  • Males and females of age ≥ 18
  • Histologically or cytologically confirmed pancreatic adenocarcinoma that has metastatic disease measurable by CT, MRI, or PET
  • Subjects with unresectable pancreatic cancer who have had surgery (exploratory laparotomy, biliary, gastrointestinal bypass) are eligible, if the subject has fully recovered from surgery and ≥ 14 days has passed since the operation. Patients with history of pancreatoduodenectomy are eligible provided that there is radiographically documented disease recurrence.
  • ECOG performance status 0-2
  • Laboratory values that would not prevent the patient from receiving chemotherapy as determined by the PI or study oncologist
  • G6PD status ≥ lower limit of normal
  • Serum creatinine ≤ 2.0 mg/dL

Exclusion Criteria:

  • Islet cell or acinar cell carcinoma or cystadenocarcinoma
  • History or known presence of central nervous system (CNS) metastases
  • History of another primary cancer, except:
  • Curatively treated cervical carcinoma in situ, or
  • Curatively resected non-melanomatous skin cancer, or
  • Other primary solid tumor curatively treated with no known active disease present and no treatment administered for ≥ 3 years prior to enrollment
  • Other concurrent anticancer chemotherapy
  • Prior radiotherapy ≤ 14 days, or if subjects have not recovered from radiotherapy
  • Uncontrolled seizure disorder or other serious neurological diseases
  • Any co-morbid disease that would increase risk of toxicity as determined by PI
  • Only locally advanced disease
  • Prior treatment with gemcitabine (for metastatic pancreatic cancer)
  • Subjects requiring chronic use of immunosuppressive agents (eg, methotrexate, cyclosporine, corticosteroids)
  • Recent infection requiring a course of systemic anti-infection that was completed ≤ 14 days prior to enrollment (exception can be made at the judgment of the PI for oral treatment of an uncomplicated urinary tract infection ([UTI])
  • History of any medical or psychiatric condition or addictive disorder, or laboratory abnormality that, in the opinion of the PI, may increase the risks associated with study participation or study drug administration or may interfere with the conduct of the study or interpretation of study requirements
  • Subject unwilling or unable to comply with study requirements
  • Subject who is pregnant or breast feeding
  • Known positive test(s) for human immunodeficiency virus infection, hepatitis C virus, chronic active hepatitis B infection
  • Documented history of alcohol, cocaine or intravenous drug abuse ≤ 6 months of enrollment
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Please refer to this study by its identifier: NCT01555489

United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
Principal Investigator: Daniel A Monti, MD Thomas Jefferson University
Study Chair: Edith P Mitchell, MD Thomas Jefferson University
  More Information

Additional Information:
Responsible Party: Thomas Jefferson University Identifier: NCT01555489     History of Changes
Other Study ID Numbers: 11D.365
Study First Received: February 22, 2012
Last Updated: January 31, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Thomas Jefferson University:
Pancreatic Neoplasms
Pancreatic Cancer cells
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Ascorbic Acid
Gemcitabine Vitamins
Vitamin C
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Growth Substances
Integrative Medicine
Alternative Medicine
Complementary Medicine

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Ascorbic Acid
Erlotinib Hydrochloride
Molecular Mechanisms of Pharmacological Action
Growth Substances
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Protein Kinase Inhibitors
Protective Agents processed this record on April 25, 2017