New Treatment Option for Pancreatic Cancer
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Cancer, Pancreatic Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 6/21/2018 |
| Start Date: | April 2011 |
| End Date: | October 2015 |
Translation of in Vitro and in Vivo Ascorbate Research Into a New Treatment Option for Pancreatic Cancer: Phase I/IIa Clinical Trial
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.
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.
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.
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.
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.
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