Randomized Phase II Evaluation of Carboplatin/Paclitaxel With and Without Trastuzumab (Herceptin) in HER2/Neu+ Patients With Advance/Recurrent Uterine Serous Papillary Carcinoma
Who is this study for? Patients with Endometrial Cancer
Status: Completed
Location: See all (20) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The primary objective of this study is to estimate whether the addition of trastuzumab to paclitaxel and carboplatin chemotherapy improves progression free survival when compared to paclitaxel and carboplatin alone in Uterine Serous Papillary Carcinoma (USPC) patients overexpressing Her2/neu at 3+ level by immunohistochemistry (IHC)or positive by fluorescence in situ hybridization (FISH).
Eligibility
Participation Requirements
Sex: Female
Healthy Volunteers: f
View:
• Patients must have advanced (stage III-IV) or recurrent histologically confirmed USPC with measurable disease.
• Patients must harbor a tumor HER2/neu+ based upon IHC staining score of 3+ or 2+ with confirmed gene amplification by FISH
Locations
United States
Arizona
St. Joseph's Hospital and Medical Center
Phoenix
University of Arizona Cancer Center
Tucson
California
John Muir Clinical Research Center
Concord
Women's Cancer Research Foundation
Newport Beach
Colorado
Penrose St. Francis Hospital
Colorado Springs
Connecticut
Danbury Hospital
Danbury
University of Connecticut Health Center
Farmington
The Hospital of Central Connecticut
New Britain
Smilow Cancer Hospital at Yale New Haven
New Haven
Illinois
The University of Chicago Medicine
Chicago
Maryland
Greater Baltimore Medical Center
Baltimore
Walter Reed National Military Medical Center
Bethesda
Holy Cross Hospital
Silver Spring
University of Maryland Medical Center
Silver Spring
North Carolina
Duke University School of Medicine
Durham
New Jersey
Jersey Shore University Medical Center
Neptune
New York
Montefiore Medical Center
Bronx
Ohio
Cleveland Clinic
Cleveland
The Ohio State University
Hilliard
Virginia
University of Virginia
Charlottesville
Time Frame
Start Date: 2011-06
Completion Date: 2022-06-30
Participants
Target number of participants: 61
Treatments
Active_comparator: Carboplatin/Paclitaxel
Chemotherapy
Experimental: Trastuzumab
Monoclonal antibody
Authors
Related Therapeutic Areas
Sponsors
Collaborators: Genentech, Inc.
Leads: Yale University