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

This study has been completed.
Sponsor:
Collaborators:
University of Iowa
Holden Comprehensive Cancer Center
Information provided by (Responsible Party):
Joseph J. Cullen, University of Iowa
ClinicalTrials.gov Identifier:
NCT01049880
First received: January 14, 2010
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Pancreatic Neoplasms
Drug: Gemcitabine with escalating ascorbic acid
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Trial of Ascorbic Acid and Gemcitabine for the Treatment of Metastatic Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • Blood cell counts (neutropenia, thrombocytopenia) and serum chemistries (liver function tests, creatinine) [ Time Frame: weekly ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Plasma ascorbate level (targeted to 350 to 400 mg/dL) [ Time Frame: Weekly ] [ Designated as safety issue: No ]
  • Survival [ Time Frame: Ongoing ] [ Designated as safety issue: Yes ]

Enrollment: 15
Study Start Date: December 2009
Study Completion Date: March 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01049880

Locations
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
Principal Investigator: Joseph J Cullen, M.D. The University of Iowa
  More Information

Additional Information:
Publications:
Responsible Party: Joseph J. Cullen, Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT01049880     History of Changes
Other Study ID Numbers: 200804753
Study First Received: January 14, 2010
Last Updated: May 19, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Iowa:
Ascorbic Acid
Gemcitabine

Additional relevant MeSH terms:
Neoplasms
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Ascorbic Acid
Gemcitabine
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Growth Substances
Antimetabolites, Antineoplastic
Antimetabolites
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on July 20, 2014