Intravenous Vitamin C in Combination With Standard Chemotherapy for Pancreatic Cancer

Sidney Kimmel Cancer Center at Thomas Jefferson University

Status and phase: Completed; Phase 1

Conditions: Metastatic Pancreatic Cancer

Treatments: Drug: Gemcitabine and Erlotinib; Dietary Supplement: Intravenous Vitamin C

Study type: Interventional

Funder types: Other

Identifiers

NCT00954525

09D.99

JT 1473 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Intravenous Vitamin C

Experimental group

Treatment:

Dietary Supplement: Intravenous Vitamin C

Drug: Gemcitabine and Erlotinib