A Research Trial of High Dose Vitamin C and Chemotherapy for Metastatic 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

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2013-03-31

Brief Summary

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This study is designed to determine the maximum tolerated dose of vitamin C when given with a standard chemotherapy for people who have metastatic pancreatic cancer.

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Detailed Description

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This is a phase I, dose-escalating study of ascorbic acid (vitamin C) designed to determine the maximum tolerated dose of vitamin C or, if well tolerated, the dose required to obtain a desired ascorbic acid plasma concentration.

Because this is a phase I study, prospective subjects should have advanced disease (i.e., metastasis) and have failed other curative therapies (or, are unable to receive curative therapies due to comorbidities or stage of disease).

Conditions

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Pancreatic Neoplasms

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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Ascorbate

Group Type EXPERIMENTAL

Gemcitabine with escalating ascorbic acid

Intervention Type DRUG

Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off. Ascorbic acid, given twice weekly, escalating doses weekly. Week 1: 15 grams ascorbic acid per infusion Week 2: 25 grams ascorbic acid per infusion Week 3: 50 grams ascorbic acid per infusion Week 4: 75 grams ascorbic acid per infusion Week 5: 100 grams ascorbic acid per infusion

Ascorbic acid infusion dose is maintained at the level that provides a serum level of 350-400 mg/dL.

Interventions

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Gemcitabine with escalating ascorbic acid

Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off. Ascorbic acid, given twice weekly, escalating doses weekly. Week 1: 15 grams ascorbic acid per infusion Week 2: 25 grams ascorbic acid per infusion Week 3: 50 grams ascorbic acid per infusion Week 4: 75 grams ascorbic acid per infusion Week 5: 100 grams ascorbic acid per infusion

Ascorbic acid infusion dose is maintained at the level that provides a serum level of 350-400 mg/dL.

Intervention Type DRUG

Other Intervention Names

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Gemzar Ascor L 500

Eligibility Criteria

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Inclusion Criteria

* Normal G6PD status
* Histologically or cytologically diagnosed pancreatic adenocarcinoma.
* Disease extent documented by CT scan (radiologically measurable disease is not required)
* Ambulatory patient without evidence of spinal cord compression
* No prior chemotherapy for metastatic disease
* Failed curative therapy or patient ineligible for definitive curative therapy
* Completed adjuvant therapy at least 4 weeks prior and recovered from any/all toxicities related to that treatment.
* If post-therapy, must have disease progression since that treatment
* If treated with prior radiation therapy, disease must be outside of the radiation fields
* No currently active second malignancies unless it is a non-melanoma skin cancer
* Women must be non-pregnant and non-lactating
* ECOG performance of 0, 1, or 2
* Granulocytes at least 1,500 / ul
* Platelets at least 100,000 / ul
* Creatinine less than 1.5 mg/dL or clearance of at least 60 mL / min
* Total bilirubin less than 2 times the upper limit of normal
* AST and ALT less than 3 times the upper limit of normal if liver metastases are not present. If liver metastases are present, AST and ALT less than 5 times the upper limit of normal
* PT INR less than 1.5 (unless the patient is on full dose warfarin)
* Patient must be at least 18 years of age
* Patient must be able to understand consent process, the research study, and be able to sign the consent document

Exclusion Criteria

* A psychiatric disorder by history or examination that would prevent completion of the study
* ECOG performance of 3 or 4
* Co-morbid conditions that affect survival: end stage congestive heart failure, unstable angina, myocardial infarction (within the past 6 weeks), uncontrolled blood sugars of greater than 300 mg/dL, known chronic active hepatitis or cirrhosis.
* Consumption of excess alcohol (more than 4 drinks per day) or use of illicit drugs
* Continued sse of over-the-counter antioxidants (supplements like vitamin C and grape seeds)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No