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Antioxidant Effects on the Outcome of Ovarian Cancer


N/A
N/A
N/A
Open (Enrolling)
Both
Ovarian Cancer

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Trial Information

Antioxidant Effects on the Outcome of Ovarian Cancer


The subjects are randomized to 2 study groups. Group 1 receives standard chemotherapy
prescribed by the cancer doctor (carboplatin and paclitaxel)with a possible choice to extend
chemotherapy for up to an additional 12 months.

Group 2 receives standard chemotherapy in the same manner as group 1. In addition, they
receive 12 months of oral or IV nutritional supplements.


Inclusion Criteria:



- histologically confirmed carcinoma of the ovary stage III or IV

- measurable or assessable disease

- drug refractory ovarian cancer

- must be 18 years of age or must have parental consent to enroll in the study

- must be ambulatory

Exclusion Criteria:

- evidence of significant psychiatric disorder by history or exam

- consumption of excess alcohol (more than 4 of any of the following per day: 30 ml
distilled spirits, 340 ml beer, or 120 ml wine) or recreational drugs

- tobacco use

- prior treatment with an investigational drug, chemo, radiation therapy, or hormonal
therapy within the preceeding month

- pregnancy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Adverse events by NCI CTC version 3.0

Outcome Time Frame:

At each oncology clinic visit

Safety Issue:

Yes

Principal Investigator

Jeanne A. Drisko, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Kansas

Authority:

United States: Food and Drug Administration

Study ID:

7823

NCT ID:

NCT00228319

Start Date:

October 2002

Completion Date:

July 2013

Related Keywords:

  • Ovarian Cancer
  • Ovarian Neoplasms

Name

Location

University of Kansas Medical CenterKansas City, Kansas  66160-7353