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Safety of Oral Antioxidants and Intravenous Vitamin C During GYN Cancer Care

Phase 2
Open (Enrolling)
Ovarian Cancer, Cervical Cancer, Uterine Cancer

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Trial Information

Safety of Oral Antioxidants and Intravenous Vitamin C During GYN Cancer Care

It is known that cancer patients use antioxidants at greater rates than their healthy peers
and these patients generally do not tell their physicians. This use has not been adequately
evaluated. This pilot trial is a Phase II study designed to assess safety of high-dose
antioxidants in gynecologic malignancies. Secondarily, we will evaluate efficacy of
antioxidant use. These goals will be accomplished by monitoring adverse events by clinical
evaluation, metabolic functions such as but not limited to tumor markers, blood counts,
hepatic, and renal enzymes, and tumor response rates secondarily. The study will be
conducted at the University of Kansas Medical Center. Oversight partnership is established
with the FDA-CDER, Kansas Masonic Cancer Research Institute, and the University of Kansas
Medical Center - IRB.

The study is an open label prospective investigational study in 50 gynecologic cancer
patients with a Primary Hypothesis: To assess safety of adding high-dose antioxidants to
chemotherapy in the treatment of gynecologic malignancies (uterine, cervical, or epithelial
ovarian). Qualitative and quantitative toxicities will be assessed by monitoring clinical
status by National Cancer Institute common toxicity criteria version 3.0, quality of life
measures (FACT-G), and evaluating metabolic functions including but not limited to hepatic
and renal function.

Secondary Hypothesis: To assess efficacy by tumor response rates in patients with
gynecologic malignancies treated with antioxidants to include intravenous and oral ascorbic
acid, intravenous glutathione, oral mixed carotenoids, mixed tocopherols, and vitamin A.
Secondary endpoints will be time to progression and survival.

Patients with newly diagnosed or recurrent gynecologic cancer will be invited to participate
and these subjects will be limited to those who present with cervical, uterine, or ovarian
of epithelial origin. Fifty patients will be enrolled. The study subjects will be treated
with antioxidants added to their usual oncologic care for 12 months. This population was
chosen because of anecdotal and case report evidence for benefit when high-dose antioxidants
are added to their care.

Inclusion Criteria:

- Patients must have histologically or cytologically diagnosed adenocarcinoma and/or
sarcoma or squamous cell carcinoma of gynecologic origin (uterine, ovary, cervical)
that is newly diagnosed or relapsed. Tumors of the ovary are restricted to epithelial
origin. There must be evidence for advanced stage neoplasms and/or patients in need
of chemotherapy for metastatic disease.

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

- Patients must be of ambulatory status without evidence of active brain metastasis or
spinal cord compression.

- ECOG Performance Status 0-2. (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

- Laboratory: ANC =1,500/mm3, Hemoglobin > 8g/dL, platelet = 1000,000/mm3, total
bilirubin = 1.5 mg/dL, 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.

- Willingness to take oral nutrients and answer FACT-G QOL questionnaires

- 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:

- G-6PD deficient

- Ovarian tumors: sarcomas, germ cell, or any atypical cell line other than epithelial

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

- History of bleeding disorder or hemochromatosis

- Patients undergoing radiation therapy

- Patients enrolled in other trials currently or in the preceding 3 months.

- 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. Of note,
patients who continue or begin to smoke are not allowed to continue with the protocol
because we are unable to achieve elevation of the plasma vitamin C level to the
desired 400 mg/dL. (Unless 400 mg/dL plasma level is achieved, there is no (presumed)
chemotherapeutic action of the high-dose intravenous ascorbate). The inability to
achieve the desired plasma level of ascorbate is presumably related to increased
oxidative stress from the smoking itself. Patients will be clearly made aware of the
possibility of coming off of protocol if they smoke. We will monitor cotinine levels
(nicotine metabolite) in suspected smokers.

- Patients who are unwilling to take the oral antioxidants will not be allowed to

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Laboratory analysis, NCI Common Criteria for Toxicity version 3

Outcome Time Frame:

Completion of study

Safety Issue:


Principal Investigator

Jeanne Drisko, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Kansas


United States: Food and Drug Administration

Study ID:




Start Date:

September 2005

Completion Date:

December 2013

Related Keywords:

  • Ovarian Cancer
  • Cervical Cancer
  • Uterine Cancer
  • Uterine Cervical Neoplasms
  • Ovarian Neoplasms
  • Uterine Neoplasms