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

• Status: Terminated
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Thomas Jefferson University
• Treatments: Ascorbic Acid; Gemcitabine; Molecular Mechanisms of Pharmacological Action; Vitamins

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