Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Clinical Benefit of Topoisomerase Downregulation
This study has been completed.
Sponsored by: University of New Mexico
Information provided by: University of New Mexico
ClinicalTrials.gov Identifier: NCT00250094
  Purpose

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.


Condition Intervention Phase
Ovarian Cancer
Drug: Topotecan and VP16
Phase I

MedlinePlus related topics: Cancer Ovarian Cancer
Drug Information available for: Etoposide Topotecan hydrochloride Topotecan Etoposide phosphate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title: Clinical Benefit of Topoisomerase Downregulation: A Phase I Pilot Study

Further study details as provided by University of New Mexico:

Primary Outcome Measures:
  • To determine the regulation of topoisomerase I and II following alternating prolonged exposure to topotecan and etoposide (VP-16) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To determine the time to progression and the objective response rate of this treatment in patients with incurable ovarian cancer [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Enrollment: 15
Study Start Date: May 2004
Study Completion Date: March 2006
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Topotecan and VP16

    Course 1A: On day 1 treatment will start with a continuous infusion of TPT at 0.4 mg/m2/day for 21 days. A pump will be used to deliver the TPT. The bag in the pump will be replaced every week for sterility precautions.

    Course 1B: On day 28, if ANC is >1,500 and platelets > 100,000, VP-16 will be administered orally at 50 mg/day for 14 days.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00250094

Locations
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131
Sponsors and Collaborators
University of New Mexico
Investigators
Principal Investigator: Claire F Verschraegen, MD University of New Mexico
  More Information

Responsible Party: University of New Mexico - CRTC ( Claire Verschraegen, MD; Principal Investigator )
Study ID Numbers: 0603C
Study First Received: November 3, 2005
Last Updated: October 1, 2008
ClinicalTrials.gov Identifier: NCT00250094  
Health Authority: United States: Institutional Review Board

Keywords provided by University of New Mexico:
Phase I
Ovarian Cancer
Ovary
Cancer

Study placed in the following topic categories:
Ovarian cancer
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Etoposide phosphate
Genital Diseases, Female
Endocrinopathy
Topotecan
Etoposide
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Adnexal Diseases

ClinicalTrials.gov processed this record on January 16, 2009