NCT00054119

Karenitecin in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer

A Phase II Evaluation of Karenitecin in the Third-Line Treatment of Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Gynecologic Oncology Group · Network
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

Phase II trial to study the effectiveness of karenitecin in treating patients who have persistent or recurrent ovarian epithelial cancer or primary peritoneal cancer that has not responded to platinum-based treatment. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

Detailed description

OBJECTIVES: I. Determine the antitumor activity of karenitecin in patients with persistent or recurrent platinum-resistant ovarian epithelial or primary peritoneal cancer. II. Determine the toxicity of this drug in these patients. OUTLINE: This is an open-label study. Patients receive karenitecin IV over 1 hour on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Conditions

• Primary Peritoneal Carcinoma
• Recurrent Ovarian Carcinoma

Interventions

Type	Name	Description
DRUG	Cositecan	Given IV
OTHER	Pharmacological Study	Correlative studies

Timeline

• Start date: 2003-01-01
• Primary completion: 2005-09-30
• First posted: 2003-02-06
• Last updated: 2017-07-13

Locations

1 site across 1 country: United States