Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
University of New Mexico |
---|---|
Information provided by: | University of New Mexico |
ClinicalTrials.gov Identifier: | NCT00250094 |
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 |
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 |
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) |
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.
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, New Mexico | |
University of New Mexico | |
Albuquerque, New Mexico, United States, 87131 |
Principal Investigator: | Claire F Verschraegen, MD | University of New Mexico |
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 |
Phase I Ovarian Cancer Ovary Cancer |
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 |
Neoplasms Neoplasms by Site Adnexal Diseases |