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Clinical Benefit of Topoisomerase Downregulation: A Phase I Pilot Study

Phase 1
18 Years
Not Enrolling
Ovarian Cancer

Thank you

Trial Information

Clinical Benefit of Topoisomerase Downregulation: A Phase I Pilot Study

The rationale to study the downregulation of topoisomerase enzyme in ovarian cancer in
relationship to the cell cycle distribution of the cancer cells after a prolonged continuous
exposure to topo I and II poisons is to better understand the relationship between cell
cycle and topo poisoning, which may lead to better clinical trial designs.

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.

Type of Study:


Study Design:

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

Outcome Measure:

To determine the regulation of topoisomerase I and II following alternating prolonged exposure to topotecan and etoposide (VP-16)

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Claire F Verschraegen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of New Mexico


United States: Institutional Review Board

Study ID:




Start Date:

May 2004

Completion Date:

March 2006

Related Keywords:

  • Ovarian Cancer
  • Phase I
  • Ovarian Cancer
  • Ovary
  • Cancer
  • Ovarian Neoplasms



University of New Mexico Albuquerque, New Mexico  87131