NCT00003892

ISIS 5132 in Treating Patients With Metastatic or Recurrent Ovarian Cancer

Phase II Study of CGP 69846A (ISIS 5132) in Recurrent Epithelial Ovarian Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: NCIC Clinical Trials Group · Network
• Sex: Female
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of ISIS 5132 in treating patients who have metastatic or recurrent ovarian cancer that has not responded to previous chemotherapy.

Detailed description

OBJECTIVES: I. Determine the efficacy of ISIS 5132 by evaluating objective response and duration of response in patients with recurrent ovarian epithelial cancer. II. Determine the tolerability and quantitative toxicity of ISIS 5132 in this patient population. OUTLINE: This is a multicenter study. Patients receive ISIS 5132 IV continuously for 21 days. Courses are repeated every 28 days. Treatment continues for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity. Patients with documented complete response receive an additional 2 courses. Patients with documented partial response receive an additional 4 courses. Patients are followed at 4 weeks, then every 3 months until disease relapse or progression. PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study over 12-15 months.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	ISIS 5132	4mg/kg/day IV for 21 days every 4 weeks.

Timeline

• Start date: 1999-02-01
• Primary completion: 2000-10-17
• Completion: 2008-09-22
• First posted: 2004-08-05
• Last updated: 2020-04-06

Locations

66 sites across 3 countries: United States, Canada, United Kingdom

Regulatory

• FDA-regulated drug study