NCT00250094

Clinical Benefit of Topoisomerase Downregulation

Clinical Benefit of Topoisomerase Downregulation: A Phase I Pilot Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: New Mexico Cancer Research Alliance · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2004-05-01
• Primary completion: 2005-06-01
• Completion: 2006-03-01
• First posted: 2005-11-07
• Last updated: 2011-09-07

Locations

1 site across 1 country: United States