A Randomised,Double Blind, Placebo Controlled, Multicentre Trial of Abagovomab Maintenance Therapy in Patients With Epithelial Ovarian Cancer After Complete Response to First Line Chemotherapy
Standard initial treatment of ovarian cancer patients includes both surgery and chemotherapy
which in the vast majority of cases achieves the disappearance of ovarian cancer lesions.
This status, called "clinical remission" which means having no evidence of cancer on CT scan
or physical examination needs to be carefully follow up in order to confirm the maintenance
of the remission status or to early detect if the cancer grows again and then start a new
chemotherapy. At present, no approved therapies exist for the maintenance treatment of
patients who achieved the clinical remission.
This trial aims to evaluate if the repeated vaccination with Abagovomab creates an
immunoresponse which is able to fight the cancer cells thus keeping the remission status as
long as possible and help patients live disease-free and longer.
Patients who achieve the remission status after chemotherapy will be screened for study
participation and if they meet the criteria for inclusion they will start to receive a
single subcutaneous injection every 2 weeks (for the first 4 doses - induction phase) and
then every 4 weeks (maintenance phase). The duration of treatment is up to approximately 4
years or it will be stopped in case relapse occurs.
In order to evaluate the real benefit of vaccination, the experimental treatment includes
Abagovomab (the active drug) or placebo (the vehicle only, without drug), with a double
chance to receive Abagovomab. Assignment of Abagovomab or placebo will be done by a
computerised system and nobody in the study will know which treatment has been allocated
until study end.
Patients will be visited every 4 weeks and will undergo CT scan of pelvis and abdomen every
12 weeks in order to confirm the remission status or to early detect if relapse eventually
occurs. This will be done in blind condition (i.e. without being aware which treatment the
patient is going to receive) for the first part of the study which is expected to last four
years. After then the overall status of patient will continue to be monitored by phone
contact for additional five years.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Recurrence Free Survival Evaluated by Clinical Event Adjudication Committee (CEAC)
The Recurrence free survival correspond to the time from date of randomization to documented disease recurrence or death. Disease recurrence is defined as the appearance of any lesion or development of tumor-related symptoms evaluated by medical examination and must be confirmed by a documented CT scan.
Every 12 weeks up to recurrence or up to 3 months after last administered dose
Jacobus Pfisterer, MD
AGO-OVAR, Ovarian Cancer Study Group, Germany; Ubbo-Emmius-Klinik gGmbH Aurich, Germany
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Stanford University||Stanford, California 94305|
|Cedars-Sinai Medical Center||Los Angeles, California 90048|
|Florida Hospital Cancer Institute||Orlando, Florida 32804|
|University of Connecticut Health Center||Farmington, Connecticut 06360-7106|
|Women and Infants Hospital of Rhode Island||Providence, Rhode Island 02905|
|University of Colorado||Denver, Colorado 80217|
|University of Pittsburgh||Pittsburgh, Pennsylvania 15261|
|Duke University Medical Center||Durham, North Carolina 27710|
|Wayne State University||Detroit, Michigan 48202|
|Washington University||St. Louis, Missouri 63110|
|Indiana University Cancer Pavilion||Indianapolis, Indiana 46202|
|University of Miami||Miami, Florida 33136|
|The West Clinic||Memphis, Tennessee 38120|
|Harry and Jeanette Weinberg Cancer Institute at Franklin Square||Baltimore, Maryland 21237|
|University of California, Los Angeles (UCLA)||Los Angeles, California 90095-1740|
|Curtis and Elizabeth Anderson Cancer Institute||Savannah, Georgia 31404|
|The Cancer Care Center||Saint Louis, Missouri 63141|
|Women's Cancer Center||Las Vegas, Nevada 89109|
|Hackensack University Medical Center, Obstetrics and Gynecology Oncology||Hackensack, New Jersey 07601|
|Memorial Sloan-Kettering Cancer Centre||New York, New York 10021|