NCT00585052

A Phase II Study of Interaction of Lovastatin and Paclitaxel For Patients With Refractory or Relapsed Ovarian Cancer

A Phase II Study of the Synergistic Interaction of Lovastatin and Paclitaxel For Patients With Refractory or Relapsed Ovarian Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: University of Iowa · Academic / Other
• Sex: Female
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find out if the treatment combination of paclitaxel and lovastatin is more effective than the currently available chemotherapy for refractory or relapsed ovarian cancer. This research is being done to improve on currently available chemotherapy for ovarian cancer.

Detailed description

The main goal of the study is to find out if adding lovastatin to paclitaxel increases the number of people whose tumors shrink or whose disease responds to the treatment. Another purpose of the study is to find out how long tumors stay reduced in size before growing again as well as how long people live after receiving paclitaxel and lovastatin. The study will also gather information on the side effects, if any, of this combination of paclitaxel and lovastatin.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	Paclitaxel	Paclitaxel will be given at 80 mg/m2 IV over 1 hour on day 1 and repeated weekly
DRUG	Lovastatin	Lovastatin, 80 mg, po, daily will be self-administered by the subject.

Timeline

• Start date: 2003-08-01
• Primary completion: 2010-02-01
• Completion: 2013-06-01
• First posted: 2008-01-02
• Last updated: 2018-01-05
• Results posted: 2018-01-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study