Intravenous Vitamin C in Combination With Standard Chemotherapy for Pancreatic Cancer

Study Overview
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Brief Summary
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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.

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

Conditions
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Metastatic Pancreatic Cancer

Intervention / Treatment
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* Drug: Gemcitabine and Erlotinib
* Dietary Supplement: Intravenous Vitamin C


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intravenous Vitamin C<br> | Drug: Gemcitabine and Erlotinib<br>* Gemcitabine (dose according to study protocol), Erlotinib (100 mg/day)<br>Dietary Supplement: Intravenous Vitamin C<br>* 50 grams, 75 grams, or 100 grams of intravenous vitamin C, three times per week for 8 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety, assessed by toxicity (graded by NCI CTC), urinalysis, ECG, basic metabolic panel, CBC, and osmolality. |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreatic Cancer