Evaluation of Carboplatin/Paclitaxel With and Without Trastuzumab (Herceptin) in Uterine Serous Cancer

Completed · Phase 2

Conditions studied: Endometrial Cancer

In brief

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).

Key facts

Study ID

NCT01367002

Run by

Yale University

People needed

61

Starts

2011-06-01

Expected to finish

2022-06-30

Last updated by the study team

2023-05-17

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancers, significant history of cardiac disease, uncontrolled hypertension, unstable medical issue, brain leptomeningeal, prior therapy with trastuzumab, uncontrolled seizure disorder, seropositive for HIV, active hepatitis, hemorrhagic diathesis or requiring supplemental oxygen.

Where it is running

• St. Joseph's Hospital and Medical Center — Phoenix, Arizona, United States
• University of Arizona Cancer Center — Tucson, Arizona, United States
• John Muir Clinical Research Center — Concord, California, United States
• Women's Cancer Research Foundation — Newport Beach, California, United States
• Penrose St. Francis Hospital — Colorado Springs, Colorado, United States
• Danbury Hospital — Danbury, Connecticut, United States
• University of Connecticut Health Center — Farmington, Connecticut, United States
• The Hospital of Central Connecticut — New Britain, Connecticut, United States
• Smilow Cancer Hospital at Yale New Haven — New Haven, Connecticut, United States
• The University of Chicago Medicine — Chicago, Illinois, United States
• Greater Baltimore Medical Center — Baltimore, Maryland, United States
• Walter Reed National Military Medical Center — Bethesda, Maryland, United States
• Holy Cross Hospital — Silver Spring, Maryland, United States
• University of Maryland Medical Center — Silver Spring, Maryland, United States
• Jersey Shore University Medical Center — Neptune City, New Jersey, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Duke University School of Medicine — Durham, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• The Ohio State University — Hilliard, Ohio, United States
• University of Virginia — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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