A Phase II Trial of Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) With Weekly Protein Bound Paclitaxel (Abraxane™) as Chemoimmunotherapy for Platinum-Refractory/Resistant Epithelial Ovarian, Primary Peritoneal and Fallopian Tube Cancer
PRIMARY OBJECTIVES:
I. To determine whether chronic GM-CSF administration during and after cytotoxic
chemotherapy with paclitaxel albumin-stabilized nanoparticle formulation can induce a longer
remission than experienced in the most recent platinum-containing regimen.
SECONDARY OBJECTIVES:
I. To determine the extent to which chronic GM-CSF administration can increase the number of
activated monocytes in patients with advanced stage epithelial ovarian cancer.
II. To determine the extent to which chronic GM-CSF administration can increase the number
and activation state of peripheral circulating antigen presenting cells, such as dendritic
cells and activated monocytes, in patients with advanced epithelial ovarian cancer.
III. To determine the extent to which chronic GM-CSF administration can increase the number
and functional status of T cells that recognize tumor specific antigens in patients with
advanced stage epithelial ovarian cancer.
IV. To determine the extent to which chronic GM-CSF administration can increase the number
and functional status of antigen specific T cells that recognize foreign pathogens in
patients with advanced stage epithelial ovarian cancer.
OUTLINE:
INDUCTION THERAPY: Patients receive GM-CSF subcutaneously (SC) once daily on days 16-26.
Patients also receive paclitaxel albumin-stabilized nanoparticle formulation intravenously
(IV) over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4-6 courses
in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Beginning 14 days after last GM-CSF injection, patients receive GM-CSF
SC once daily on days 1-15. Treatment repeats every 28 days for up to 6 courses in the
absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up monthly for 6 months and then
every 3 months thereafter.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Time to progression
Up to 5 years
No
Barbara Goff
Principal Investigator
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Institutional Review Board
6168
NCT00466960
May 2006
Name | Location |
---|---|
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle, Washington 98109 |