NCT00499252

Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

A Phase II Evaluation of Abraxane® in the Treatment of Recurrent or Persistent Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Gynecologic Oncology Group · Network
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

This phase II trial is studying the side effects and how well paclitaxel albumin-stabilized nanoparticle formulation works in treating patients with recurrent or persistent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

Detailed description

PRIMARY OBJECTIVES: I. Determine the antitumor activity of paclitaxel albumin-stabilized nanoparticle formulation (Abraxane®), in terms of frequency and duration of objective response, in patients with persistent or recurrent platinum-resistant ovarian epithelial, fallopian tube, or primary peritoneal cancer. II. Determine the toxicity of this drug in these patients. SECONDARY OBJECTIVES: I. Determine the duration of progression-free survival and overall survival of patients treated with this drug. OUTLINE: This is a multicenter study. Patients receive paclitaxel albumin-stabilized nanoparticle formulation (Abraxane®) IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.

Conditions

• Fallopian Tube Carcinoma
• Primary Peritoneal Carcinoma
• Recurrent Ovarian Carcinoma

Interventions

Type	Name	Description
DRUG	Paclitaxel Albumin-Stabilized Nanoparticle Formulation

Timeline

• Start date: 2007-06-01
• Primary completion: 2011-07-01
• First posted: 2007-07-11
• Last updated: 2018-01-11
• Results posted: 2013-12-13

Locations

20 sites across 1 country: United States