New Treatment Option for Pancreatic Cancer

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Brief Title

New Treatment Option for Pancreatic Cancer

Official Title

Translation of in Vitro and in Vivo Ascorbate Research Into a New Treatment Option for Pancreatic Cancer: Phase I/IIa Clinical Trial

Brief Summary

      In the United States, approximately 30,000 new cases of pancreatic cancer are diagnosed each
      year and an almost equal number of deaths are related to this cancer. Different types of
      chemotherapeutic treatments are used that target different parts of the cancer cell with some
      success, but there is room for other treatment options.

      It is known that people with cancer are using high doses of intravenous vitamin C also known
      as ascorbate, as a cancer treatment and this is occurring frequently. When Vitamin C is given
      in this manner, it is not taken by mouth; instead, it enters your body through an IV
      (intravenous) site, or tube that is inserted through a needle into your vein. If you have a
      port-a-cath in place, the IV will be given using your port. When Vitamin C enters your body
      through an IV site, it is known that it acts like a drug and not a vitamin. It produces a
      substance around the cancer cells called hydrogen peroxide. It has been seen in animal
      research studies that hydrogen peroxide kills the cancer cells while leaving the normal cells
      unharmed.

      Currently the FDA does not approve the use of high-dose intravenous Vitamin C as a cancer
      treatment. The use of intravenous Vitamin C in this study is experimental. Furthermore, it is
      important to know that we do not expect the intravenous Vitamin C given in this study to be
      healing for the treatment of your cancer.
    

Detailed Description

      The purpose of this study is to determine if it is safe to give Vitamin C by the vein at high
      doses to people with pancreatic cancer and if Vitamin C interferes with how well the
      chemotherapy works on cancer cells. This study will also look at how the body processes of
      Vitamin C. This study will also help researchers to learn more about long Vitamin C stays in
      the blood stream, and how rapidly it is used by the body.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Determine safety of combined gemcitabine chemotherapy with IV ascorbate.

Secondary Outcome

 Assess pharmacokinetic and pharmacodynamic interactions when adding IV AA to front-line gemcitabine chemotherapy in the treatment of locally advanced or metastatic pancreatic cancer not eligible for surgical resection.

Condition

Pancreatic Cancer

Intervention

Intravenous Vitamin C

Study Arms / Comparison Groups

 PK Intravenous Vitamin C and Gemcitabine
Description:  Week 1: 2 visits for escalating doses of intravenous ascorbic acid (IV C). First dose 25 gm followed by 50 gm 2nd visit. Week 2: 3 visits escalating doses of IV C, 75 grams, 100 grams, and 125 grams. Week 3: 2 visits pharmacokinetic evaluation of intravenous ascorbic acid alone at 125 grams; return to the infusion clinic the following morning for a 24 hour blood draw; 2nd visit receive the first infusion of gemcitabine chemotherapy for PK evaluation of gemcitabine alone. Week-4: gemcitabine and IV C co-administered for pharmacokinetics of both drugs to assess for PK variability related to drug-drug interactions. Subjects will return to the infusion clinic the following morning for 24 hour blood draw.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

14

Start Date

April 2011

Completion Date

October 2015

Primary Completion Date

October 2015

Eligibility Criteria

        Inclusion Criteria:

          -  Patients must be 21 years of age or older and have histologically or cytologically
             diagnosed carcinoma of the pancreas defined as locally advanced or metastatic and if
             locally advanced, not eligible for surgical resection

          -  The patient must screened for eligibility and have care approved by treating
             oncologist; the oncology care is to be dictated by the oncology team and patient and
             will include gemcitabine chemotherapy.

          -  ECOG Performance Status 0-2 Eastern Cooperative Oncology Group Performance Status
             Grade 0 = Fully active, able to carry on all pre-disease activities without
             restriction Grade 1= Restricted in physical strenuous activity but ambulatory and able
             to carry out work of a light or sedentary nature e.g. light housework, office work
             Grade 2 = Ambulatory and capable of all self care but unable to carry out any work
             activities, up and about more than 50% of waking hours

          -  Laboratory: ANC ≥1,500/mm3, Hemoglobin > 8g/dL, platelet ≥ 1000,000/mm3, total
             bilirubin ≤ 1.5 mg/dL (in the absence of neoplastic involvement), creatinine ≤2.0
             mg/dL, transaminase (AST/ALT) ≤2.5X upper limit, urine uric acid < 1,000mg/d, urine pH
             <6, urine oxalate <60 mg/d.

          -  Patients who have no language barrier, are cooperative, and can give informed consent
             before entering the study after being informed of the medications and procedures to be
             used in this study may participate.

        Exclusion Criteria:

          -  Glucose-6-phosphate-dehydrogenase (G6PD) deficiency

          -  History of oxalate renal calculi; urine oxalate level > 60 mg/d at baseline

          -  History of bleeding disorder, iron overload or hemochromatosis

          -  Prior chemotherapy or currently receiving chemotherapy or radiation therapy or
             enrolled in other trials currently or in the preceding 1 month.

          -  Patients with evidence of a significant psychiatric disorder by history/examination
             that would prevent completion of the study will not be allowed to participate.

          -  ECOG Performance Status of 3-4. Grade 3 = capable of only limited self care, confined
             to bed or chair more than 50% of waking hours. Grade 4 = completely disabled. Cannot
             carry on any self care. Totally confined to bed or chair.)

          -  Co-morbid condition that would affect survival: end stage congestive heart failure,
             unstable angina, myocardial infarction within 6 weeks of study, uncontrolled blood
             sugars ≥ 300 mg/dL, patients with known chronic active hepatitis or cirrhosis.

          -  Patients who consume an excess of alcohol or abuse drugs (an excess of alcohol is
             defined as more than four of any one of the following per day: 30mL distilled spirits,
             340mL beer, or 120mL wine) will not be allowed.

          -  Patients who smoke tobacco products will not be allowed to participate.
      

Gender

All

Ages

21 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Jeanne Drisko, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01364805

Organization ID

12505


Responsible Party

Sponsor-Investigator

Study Sponsor

Jeanne Drisko, MD, CNS, FACN

Collaborators

 Lotte & John Hecht Memorial Foundation

Study Sponsor

Jeanne Drisko, MD, Principal Investigator, University of Kansas Medical Center


Verification Date

June 2018