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

Phase 2

Completed

• Conditions: Endometrial Cancer
• Interventions: Drug: Carboplatin/Paclitaxel; Drug: Trastuzumab

• Registration Number: NCT01367002
• Lead Sponsor: Yale University

Brief 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).

Detailed Description

The purpose of this study is to perform a randomized Phase II evaluation of Carboplatin/Paclitaxel with or without Trastuzumab (Herceptin) in patients with HER2/neu+ advanced stage/recurrent disease with an emphasis on determining the progression free survival in USPC patients and assessing immunologic markers predictive of trastuzumab response.

Study Timeline

• Study First Submitted: 2011-05-26
• Study Start: 2011-06
• Study First Submitted QC: 2011-06-02
• Study First Posted: 2011-06-06
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Results First Submitted: 2023-03-27
• Results First Submitted QC: 2023-03-27
• Results First Posted: 2023-04-18
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-15
• Last Update Posted: 2023-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 61

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Carboplatin/Paclitaxel	Carboplatin/Paclitaxel	Chemotherapy
Trastuzumab	Trastuzumab	Monoclonal antibody

Primary Outcome Measures

Name	Time	Method
Progression Free Survival Differences Between Treatment Arms.	6 years	Progression free survival differences between treatment arms.

Secondary Outcome Measures

Name	Time	Method
To Assess Objective Response Rate (ORR)	6 years	To assess objective response rate (ORR)
To Assess the Safety Profile of Trastuzumab in USPC Patients by CTCAE v4.0	6 years	To assess the safety profile of trastuzumab in USPC patients by CTCAE v4.0. Presented are counts of those that experience any Serious Adverse Events or All Other Adverse Events.
To Assess Overall Survival (OS)	6 years	To assess overall survival (OS), presented are the number of participants that survived through the duration of the study period.

Trial Locations

Locations (20)

Jersey Shore University Medical Center; 🇺🇸 Neptune, New Jersey, United States

The Ohio State University; 🇺🇸 Hilliard, Ohio, United States

University of Arizona Cancer Center; 🇺🇸 Tucson, Arizona, United States

Holy Cross Hospital; 🇺🇸 Silver Spring, Maryland, United States

University of Maryland Medical Center; 🇺🇸 Silver Spring, Maryland, United States

Penrose St. Francis Hospital; 🇺🇸 Colorado Springs, Colorado, United States

St. Joseph's Hospital and Medical Center; 🇺🇸 Phoenix, Arizona, United States

John Muir Clinical Research Center; 🇺🇸 Concord, California, United States

Women's Cancer Research Foundation; 🇺🇸 Newport Beach, California, 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

Duke University School of Medicine; 🇺🇸 Durham, North Carolina, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States