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Phase II, Open Label Study of Intravenous Ascorbic Acid in Combination With Gemcitabine and Erlotinib in the Treatment of Metastatic Pancreatic Cancer

Phase 2
18 Years
Open (Enrolling)
Stage IV Pancreatic Cancer

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Trial Information

Phase II, Open Label Study of Intravenous Ascorbic Acid in Combination With Gemcitabine and Erlotinib in the Treatment of Metastatic Pancreatic Cancer

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.

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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety of ascorbic acid in combination with gemcitabine and erlotinib for stage IV Pancreatic cancer

Outcome Description:

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

Outcome Time Frame:

15 weeks

Safety Issue:


Principal Investigator

Daniel A Monti, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Thomas Jefferson University


United States: Food and Drug Administration

Study ID:




Start Date:

October 2011

Completion Date:

October 2014

Related Keywords:

  • Stage IV Pancreatic Cancer
  • Pancreatic Neoplasms
  • Pancreatic Cancer cells
  • Digestive System Neoplasms
  • Neoplasms by Site
  • Neoplasms
  • Endocrine Gland Neoplasms
  • Digestive System Diseases
  • Pancreatic Diseases
  • Endocrine System Diseases
  • Ascorbic Acid
  • Gemcitabine Vitamins
  • Vitamin C
  • Antioxidants
  • Molecular Mechanisms of Pharmacological Action
  • Pharmacologic Actions
  • Protective Agents
  • Physiological Effects of Drugs
  • Micronutrients
  • Growth Substances
  • Erlotinib
  • Integrative Medicine
  • Alternative Medicine
  • Complementary Medicine
  • Pancreatic Neoplasms



Thomas Jefferson UniversityPhiladelphia, Pennsylvania  19107-6541