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

NCT ID: NCT01555489

Last Updated: 2025-05-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2016-01-31

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

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.

Conditions

Stage IV Pancreatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ascorbic Acid, Gemcitabine & Erlotinib

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

Group Type: EXPERIMENTAL

Ascorbic Acid

Intervention Type: DRUG

3x per week

Interventions

Ascorbic Acid

3x per week

Intervention Type: DRUG

Other Intervention Names

Vitamin C; Ascorbate

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Thomas Jefferson University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel A Monti, MD

Role: PRINCIPAL_INVESTIGATOR

Thomas Jefferson University

Edith P Mitchell, MD

Role: STUDY_CHAIR

Thomas Jefferson University

Locations

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 22272248 (View on PubMed)

Related Links

http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0029794

Phase I results

Other Identifiers

JT 2181

Identifier Type: OTHER

Identifier Source: secondary_id

11D.365

Identifier Type: -

Identifier Source: org_study_id