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COMPLETEDPHASE1

Clinical Benefit of Topoisomerase Downregulation

Clinical Benefit of Topoisomerase Downregulation: A Phase I Pilot Study

NCT00250094•New Mexico Cancer Research Alliance

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

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

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

Locations (1)

University of New Mexico

Albuquerque, New Mexico, United States

Key Dates

Start Date

May 1, 2004

Primary Completion Date

June 1, 2005

Completion Date

March 1, 2006

Last Updated

September 7, 2011

Enrollment

ACTUAL participants

Conditions

Ovarian Cancer

Interventions

Topotecan and VP16

DRUG

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RECRUITINGPHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 7, 2011Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Clinical Benefit of Topoisomerase Downregulation

Inclusion Criteria

Exclusion Criteria

IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

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The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)