Clinical Benefit of Topoisomerase Downregulation: A Phase I Pilot Study

Inclusion Criteria:

- All patients, 18 years of age or older, with incurable ovarian advanced cancer are
eligible provided that they have measurable disease by CT-scan imaging, or evaluable
disease by tumor markers, following the criteria described by Rustin et al. (14).
(Response to a specific treatment has occurred if after two CA-125 samples there has
been a 50% decrease, confirmed by a fourth sample (50% response), or a serial
decrease over three samples of greater than 75% (75% response). The final sample has
to be at least 28 days after the previous sample.)

- Patients must have a life expectancy of at least 12 weeks.

- Patients must have a Zubrod performance status of 0-2.

- Patients must sign an informed consent.

- Patients should have adequate bone marrow function defined by an absolute peripheral
granulocyte count of > 1,500 or cells/mm3 and platelet count >100,000/mm3 and absence
of a regular red blood cell transfusion requirement.

- Patients should have adequate hepatic function with a total bilirubin < 2 mg/dl and
SGOT or SGPT < two times the upper limit of normal, and adequate renal function as
defined by a serum creatinine < 1.5 x upper limit of normal.

Exclusion Criteria:

- Patients with symptomatic brain metastases are excluded from this study.

- Pregnant women or nursing mothers are not eligible for this trial. Patients of child
bearing potential must use adequate contraception.

- Patients may receive no other concurrent chemotherapy or radiation therapy during
this trial.

- Patients with severe medical problems such as uncontrolled diabetes mellitus or
cardiovascular disease or active infections are not eligible for this trial.