A Phase II Trial Of IM862 Combined With Paclitaxel And Carboplatin In Newly Diagnosed Advanced Epithelial Ovarian Or Primary Peritoneal Carcinoma Followed By IM862 Consolidation Therapy
OBJECTIVES: I. Determine the complete pathologic response rate at second-look surgery in
patients with optimally resected stage III ovarian epithelial or primary peritoneal cancer
treated with adjuvant paclitaxel, carboplatin, and IM-862. II. Determine the safety profile
of this regimen in this patient population. III. Determine the incidence of infectious and
hematologic complications in patients treated with this regimen. IV. Determine the
progression-free survival of patients with no disease or minimal disease burden after
initial therapy, when treated with IM-862 consolidation therapy. V. Correlate angiogenesis
markers and immunologic parameters with response in patients treated with this regimen.
OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified
according to participating center. Patients are randomized to one of three IM-862 doses.
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1.
Treatment repeats every 21 days for 6 courses in the absence of disease progression or
unacceptable toxicity. Treatment with IM-862 begins within 10 days of chemotherapy
initiation and continues until clinical evidence of disease progression or until 3 days
before second-look surgery. Arm I: Patients receive a low-dose of IM-862 and 2 placebo doses
intranasally daily. Arm II: Patients receive a medium-dose of IM-862 and 2 placebo doses as
in arm I. Arm III: Patients receive higher-dose IM-862 intranasally three times daily.
Patients undergo second-look surgery within 4-8 weeks after completion of the last course of
chemotherapy. Patients with a complete pathologic response or only microscopically
detectable residual disease receive consolidation therapy with IM-862, according to their
original treatment arm. Consolidation therapy begins within 3-14 days after second-look
surgery and continues for 24 weeks in the absence of disease progression. Patients are
followed at 6 and 12 months.
PROJECTED ACCRUAL: A total of 180 patients (60 per arm) will be accrued for this study
within 1 year.
Primary Purpose: Treatment
Pamela Paley, MD
Pacific Gynecology Specialists
United States: Federal Government
|Roswell Park Cancer Institute||Buffalo, New York 14263|
|Fred Hutchinson Cancer Research Center||Seattle, Washington 98109|
|Stanford University Medical Center||Stanford, California 94305-5408|
|University of Minnesota Cancer Center||Minneapolis, Minnesota 55455|
|Washington University School of Medicine||Saint Louis, Missouri 63110|
|Lineberger Comprehensive Cancer Center, UNC||Chapel Hill, North Carolina 27599-7295|
|Arthur G. James Cancer Hospital - Ohio State University||Columbus, Ohio 43210|
|Community Hospital of Los Gatos||Los Gatos, California 95032|
|Lombardi Cancer Center||Washington, District of Columbia 20007|
|University of Wisconsin Comprehensive Cancer Center||Madison, Wisconsin 53792|
|Cleveland Clinic Taussig Cancer Center||Cleveland, Ohio 44195|
|Winship Cancer Institute||Atlanta, Georgia 30322|
|University of Nebraska Medical Center||Omaha, Nebraska 68198-3330|
|Women's Cancer Center - Las Vegas||Las Vegas, Nevada 89102|
|Fletcher Allen Health Care - Medical Center Campus||Burlington, Vermont 05401|
|University of Washington School of Medicine||Seattle, Washington 98195|
|Magee-Womens Hospital||Pittsburgh, Pennsylvania 15213-3180|
|Comprehensive Cancer Center||Glendale, California 91204|
|University of Kansas School of Medicine-Wichita||Wichita, Kansas 67214|