Clinical Benefit of Topoisomerase Downregulation

Ovarian Cancer Clinical Trial

Official title:

Clinical Benefit of Topoisomerase Downregulation: A Phase I Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00250094
• Other study ID #: 0603C
• Status: Completed
• Phase: Phase 1
• First received: November 3, 2005
• Last updated: September 2, 2011
• Start date: May 2004
• Est. completion date: March 2006

Study information

• Verified date: September 2011
• Source: New Mexico Cancer Care Alliance
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 2006
• Est. primary completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	University of New Mexico	Albuquerque	New Mexico

Sponsors (1)

Lead Sponsor	Collaborator
New Mexico Cancer Care Alliance

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the regulation of topoisomerase I and II following alternating prolonged exposure to topotecan and etoposide (VP-16)		3 years	Yes
Secondary	To determine the time to progression and the objective response rate of this treatment in patients with incurable ovarian cancer		3 years	Yes