Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
RATIONALE: 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.
PURPOSE: 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.
Fallopian Tube Cancer
Primary Peritoneal Cavity Cancer
Drug: paclitaxel albumin-stabilized nanoparticle formulation
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Evaluation of Abraxane® in the Treatment of Recurrent or Persistent Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer|
- Frequency and duration of objective response [ Designated as safety issue: No ]
- Frequency and severity of observed adverse effects [ Designated as safety issue: Yes ]
- Duration of progression-free and overall survival [ Designated as safety issue: No ]
|Study Start Date:||June 2007|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
- 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.
- Determine the toxicity of this drug in these patients.
- 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.
Show 50 Study Locations
|Study Chair:||Robert L. Coleman, MD||M.D. Anderson Cancer Center|
|Investigator:||Thomas J. Herzog, MD||Herbert Irving Comprehensive Cancer Center|