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

NCT01555489 | Terminated Phase 2 Results DMC

• 2 other identifiers: 11D.365JT 2181
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stage IV Pancreatic Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Safety of Ascorbic Acid in Combination With Gemcitabine and Erlotinib for Stage IV 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.

  15 weeks

Secondary Outcomes (1)

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

  15 weeks

Study Arms (1)

Ascorbic Acid, Gemcitabine & Erlotinib

EXPERIMENTAL

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

Drug: Ascorbic Acid

Interventions

Ascorbic Acid DRUG

3x per week

Also known as: Vitamin C, Ascorbate

Ascorbic Acid, Gemcitabine & Erlotinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (1)

• Monti DA, Mitchell E, Bazzan AJ, Littman S, Zabrecky G, Yeo CJ, Pillai MV, Newberg AB, Deshmukh S, Levine M. Phase I evaluation of intravenous ascorbic acid in combination with gemcitabine and erlotinib in patients with metastatic pancreatic cancer. PLoS One. 2012;7(1):e29794. doi: 10.1371/journal.pone.0029794. Epub 2012 Jan 17.

  PMID: 22272248 BACKGROUND

Related Links

• Phase I results

MeSH Terms

Conditions

Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Interventions

Ascorbic Acid

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Results Point of Contact

• Title: Dr. Daniel Monti
• Organization: Sidney Kimmel Cancer Center at Thomas Jefferson University

daniel.monti@jefferson.edu

215 955-2221

Study Officials

• Daniel A Monti, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

• Edith P Mitchell, MD

  Thomas Jefferson University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2012
• First Posted: March 15, 2012
• Study Start: October 1, 2011
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: May 4, 2025
• Results First Posted: August 28, 2018

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)