Clinical trial NCT00250094: Clinical Benefit of Topoisomerase Downregulation
Official title: Clinical Benefit of Topoisomerase Downregulation: A Phase I Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Ovarian Cancer
Keywords: Phase I
Ovarian Cancer
Ovary
Cancer
Lead sponsor: New Mexico Cancer Research Alliance
Sponsor class: OTHER
First posted: 2005-11-07
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 1.1 To determine the regulation of topoisomerase I and II following alternating prolonged exposure to topotecan and etoposide (VP-16)

1.2 To determine the time to progression and the objective response rate of this treatment in patients with incurable ovarian cancer.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: To determine the regulation of topoisomerase I and II following alternating prolonged exposure to topotecan and etoposide (VP-16)
timeFrame: 3 years
Secondary outcomes:
measure: To determine the time to progression and the objective response rate of this treatment in patients with incurable ovarian cancer
timeFrame: 3 years
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
Study officials:
affiliation: University of New Mexico
name: Claire F Verschraegen, MD
role: PRINCIPAL_INVESTIGATOR
References: