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Vitamin C

Ascorbic Acid (50-100g, 3x weekly) Standard Chemotherapy of Gemcitabine and Erlotinib for Pancreatic Cancer

Daniel A Monti, MD

Edith P Mitchell, MD

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

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.

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

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

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.

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.

Thomas Jefferson University

Ascorbic Acid (50-100g, 3x weekly) Standard Chemotherapy of Gemcitabine and Erlotinib for Pancreatic Cancer

Ascorbic Acid: 3x per week

Ascorbic Acid, Gemcitabine & Erlotinib

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Daniel Monti

The trial was closed due to lack of accrual. The standard of care treatment that was part of the study as initially written changed to a different chemotherapy regimen thus not enabling the team to enroll additional patients. The data were not collected.

Safety of Ascorbic Acid in Combination With Gemcitabine and Erlotinib for Stage IV Pancreatic Cancer

Evaluate Quality of Life Using Functional Assessment of Cancer Therapy-General (FACT-G) Quality Assessment Instrument

Overall Study

Colorectal Neoplasms

Colonic Diseases

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Camptothecin

Enzyme Inhibitors

Topoisomerase I Inhibitors

Cola

Ascorbic Acid (50-100g, 3x weekly) with 350mg/m2 irinotecan once a week every 3 weeks

350mg/m2 irinotecan once a week every 3 weeks

This protocol is a phase I/II, study of ascorbic acid (AA) infusions combined with treatment with irinotecan versus treatment with irinotecan alone in patients with recurrent or advanced colorectal cancer who have failed at least one treatment regimen with a 5-FU based therapy. This study will be conducted as an amendment to Investigational New Drug # 77486.

Phase I: To assess whether or not (IV) Ascorbic Acid (AA) with irinotecan therapy is relatively safe and well-tolerated. This aim will be assessed by enrolling a minimum of 6 subjects meeting inclusion criteria, using a modified 3+3 design. Safety will be assessed with the following: toxicity graded by the NCI CTC, urinalysis pre- and post-infusion, basic metabolic panel, and CBC. From our experience and in the experience of our study collaborators, we hypothesize that the combination of IV AA with irinotecan will not be associated with adverse events.

Phase II: To utilize CT or PET/CT (when available) scans to evaluate disease progression to assess overall tumor response rate (complete and partial response) in subjects with advanced or recurrent colorectal cancer treated with the combination of ascorbic acid and irinotecan versus irinotecan alone.

Research Study of IV Vitamin C in Combination With Irinotecan vs Irinotecan Alone for Advanced Colorectal CA

Phase I/II Study of Intravenous Ascorbic Acid in Combination With Irinotecan Versus Irinotecan Alone for Advanced Colorectal Cancer

Safety: The primary aim is to assess whether or not (IV) Ascorbic Acid (AA) with irinotecan therapy is relatively safe and well-tolerated according to Common Terminology Criteria for Adverse Events (CTCAE) v4.0.

To evaluate progression-free survival related to treatment of patients with advanced or recurrent colorectal cancer

The study was closed early due to lack of accrual. Adverse event data were collected for the patients who were enrolled in the study.

Ascorbic Acid (50-100g, 3x weekly)

Ascorbic Acid: 3x a week for 9 weeks

Ascorbic Acid+Irinotecan

Standard of Care (Irinotecan Alone)

Total

The Phase 2 portion of this study never enrolled and therefore no patients were enrolled to the standard of care arm.

The study was closed early due to lack of accrual. The data were not collected or analyzed.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Assessing the Efficacy and Safety of IV Vitamin C in Combination With Standard Chemotherapy for Pancreatic Ca	NCT01555489	Stage IV Pancre...	Ascorbic Acid	18 Years -	Thomas Jefferson University
Assessing the Efficacy and Safety of IV Vitamin C in Combination With Standard Chemotherapy for Pancreatic Ca	NCT01555489	Stage IV Pancre...	Ascorbic Acid	18 Years -	Thomas Jefferson University
Research Study of IV Vitamin C in Combination With Irinotecan vs Irinotecan Alone for Advanced Colorectal CA	NCT01550510	Stage IV Colore...	Ascorbic Acid Irinotecan	18 Years -	Thomas Jefferson University
Research Study of IV Vitamin C in Combination With Irinotecan vs Irinotecan Alone for Advanced Colorectal CA	NCT01550510	Stage IV Colore...	Ascorbic Acid Irinotecan	18 Years -	Thomas Jefferson University

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