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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01049880
Recruitment Status : Completed
First Posted : January 15, 2010
Last Update Posted : April 21, 2017
Sponsor:
Collaborators:
University of Iowa
Holden Comprehensive Cancer Center
Information provided by (Responsible Party):
Joseph J. Cullen, University of Iowa

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pancreatic Neoplasms Drug: Gemcitabine with escalating ascorbic acid Phase 1

Detailed Description:

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).

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Trial of Ascorbic Acid and Gemcitabine for the Treatment of Metastatic Pancreatic Cancer
Study Start Date : December 2009
Actual Primary Completion Date : February 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Ascorbate Drug: 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.

Other Names:
  • Gemzar
  • Ascor L 500


Outcome Measures
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Primary Outcome Measures :
  1. Blood cell counts (neutropenia, thrombocytopenia) and serum chemistries (liver function tests, creatinine) [ Time Frame: weekly ]

Secondary Outcome Measures :
  1. Plasma ascorbate level (targeted to 350 to 400 mg/dL) [ Time Frame: Weekly ]
  2. Survival [ Time Frame: Ongoing ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01049880


Locations
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United States, Iowa
The University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
Joseph J. Cullen
University of Iowa
Holden Comprehensive Cancer Center
Investigators
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Principal Investigator: Joseph J Cullen, M.D. University of Iowa
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Joseph J. Cullen, Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT01049880    
Other Study ID Numbers: 200804753
First Posted: January 15, 2010    Key Record Dates
Last Update Posted: April 21, 2017
Last Verified: April 2017
Keywords provided by Joseph J. Cullen, University of Iowa:
Ascorbic Acid
Gemcitabine
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Ascorbic Acid
Gemcitabine
 Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antioxidants
Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients