Intravenous Vitamin C in Combination With Standard Chemotherapy for Pancreatic Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2011-12-31

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.

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Detailed Description

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Conditions

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Metastatic Pancreatic Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intravenous Vitamin C

Group Type EXPERIMENTAL

Gemcitabine and Erlotinib

Intervention Type DRUG

Gemcitabine (dose according to study protocol), Erlotinib (100 mg/day)

Intravenous Vitamin C

Intervention Type DIETARY_SUPPLEMENT

50 grams, 75 grams, or 100 grams of intravenous vitamin C, three times per week for 8 weeks.

Interventions

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Gemcitabine and Erlotinib

Gemcitabine (dose according to study protocol), Erlotinib (100 mg/day)

Intervention Type DRUG

Intravenous Vitamin C

50 grams, 75 grams, or 100 grams of intravenous vitamin C, three times per week for 8 weeks.

Intervention Type DIETARY_SUPPLEMENT

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No