Intravenous Vitamin C in Combination With Standard Chemotherapy for Pancreatic Cancer

Metastatic Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00954525
• Other study ID #: 09D.99
• Status: Completed
• Phase: Phase 1
• Start date: July 2009
• Est. completion date: December 2011

Study information

• Verified date: June 2018
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Eligible candidates will be adults with metastatic pancreatic cancer (confirmed diagnosis with pathology reports and measurable computed tomography (CT) or magnetic resonance imaging (MRI)). Participants must not be receiving any other concurrent chemotherapy, or radiation therapy. Full inclusion/exclusion criteria are available. History and physical examination, and laboratory and imaging analyses will be done within 14 days prior to registration. The three cohorts of subjects will receive 50, 75 or 100 grams of intravenous ascorbic acid, three times per week for 8 weeks. Subjects will also have co-administration of the chemotherapy medications, gemcitabine (intravenously) and erlotinib (orally). Approximately 9 to 18 participants will be enrolled in this Phase I study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Metastatic pancreatic cancer

• Glucose 6 phosphate dehydrogenase status normal

• ECOG performance status 0-2

• Normal creatinine and transaminase

• Women of child-bearing potential confirm negative pregnancy test

Exclusion Criteria:

• Concurrent chemotherapy or radiotherapy

• Significant co-morbid disorders

• Significant psychiatric symptoms

• Prior treatment with gemcitabine

• Concurrent chronic use of immunosuppressive agents (methotrexate, cyclosporine,corticosteroids)

• Regular use of nonsteroidal anti-inflammatory agents

• Smoking more than 1 pack per day

• Excessive alcohol or drug use

• Enrollment in other experimental therapy

• Active infection

• Patients experiencing ongoing response to recent treatments

Related Conditions & MeSH terms

• Metastatic Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Gemcitabine and Erlotinib
Gemcitabine (dose according to study protocol), Erlotinib (100 mg/day)

Dietary Supplement:
• Intravenous Vitamin C
50 grams, 75 grams, or 100 grams of intravenous vitamin C, three times per week for 8 weeks.

Locations

Country	Name	City	State
United States	Jefferson-Myrna Brind Center of Integrative Medicine	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Sidney Kimmel Cancer Center at Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety, assessed by toxicity (graded by NCI CTC), urinalysis, ECG, basic metabolic panel, CBC, and osmolality.		8 weeks
Secondary	Progression-free survival		8 weeks

External Links

•   Sidney Kimmel Cancer Center at Thomas Jefferson University
•   Thomas Jefferson University Hospital