Antioxidant Effects on the Outcome of Ovarian Cancer
N/A
N/A
Both
Ovarian Cancer
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 Center | Kansas City, Kansas 66160-7353 |
