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

NCT01367002CompletedPHASE2INTERVENTIONAL

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).

Key Facts

Lead Sponsor

Yale University

Enrollment

Start Date

2011-06-01

Completion Date

2022-06-30

Study Type

INTERVENTIONAL

Official Title

Randomized Phase II Evaluation of Carboplatin/Paclitaxel With and Without Trastuzumab (Herceptin) in HER2/Neu+ Patients With Advance/Recurrent Uterine Serous Papillary Carcinoma

Interventions

Carboplatin/PaclitaxelTrastuzumab

Conditions

Endometrial Cancer

Eligibility

Sex

FEMALE

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.

Outcome Measures

Primary Outcomes

Progression Free Survival Differences Between Treatment Arms.

Progression free survival differences between treatment arms.

Time frame: 6 years

Secondary Outcomes

To Assess the Safety Profile of Trastuzumab in USPC Patients by CTCAE v4.0

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.

Time frame: 6 years

To Assess Objective Response Rate (ORR)

To assess objective response rate (ORR)

Time frame: 6 years

To Assess Overall Survival (OS)

To assess overall survival (OS), presented are the number of participants that survived through the duration of the study period.

Time frame: 6 years

Locations

St. Joseph's Hospital and Medical Center, Phoenix, United States

University of Arizona Cancer Center, Tucson, United States

John Muir Clinical Research Center, Concord, United States

Women's Cancer Research Foundation, Newport Beach, United States

Penrose St. Francis Hospital, Colorado Springs, United States

Danbury Hospital, Danbury, United States

University of Connecticut Health Center, Farmington, United States

The Hospital of Central Connecticut, New Britain, United States

Smilow Cancer Hospital at Yale New Haven, New Haven, United States

The University of Chicago Medicine, Chicago, United States

Greater Baltimore Medical Center, Baltimore, United States

Walter Reed National Military Medical Center, Bethesda, United States

Holy Cross Hospital, Silver Spring, United States

University of Maryland Medical Center, Silver Spring, United States

Jersey Shore University Medical Center, Neptune City, United States

Montefiore Medical Center, The Bronx, United States

Duke University School of Medicine, Durham, United States

Cleveland Clinic, Cleveland, United States

The Ohio State University, Hilliard, United States

University of Virginia, Charlottesville, United States

Linked Papers

2020-06-29

Randomized Phase II Trial of Carboplatin–Paclitaxel Compared with Carboplatin–Paclitaxel–Trastuzumab in Advanced (Stage III–IV) or Recurrent Uterine Serous Carcinomas that Overexpress Her2/Neu (NCT01367002): Updated Overall Survival Analysis

Abstract Purpose: Uterine-serous-carcinoma (USC) is an aggressive variant of endometrial cancer. On the basis of preliminary results of a multicenter, randomized phase II trial, trastuzumab (T), a humanized-mAb targeting Her2/Neu, in combination with carboplatin/paclitaxel (C/P), is recognized as an alternative in treating advanced/recurrent HER2/Neu-positive USC. We report the updated survival analysis of NCT01367002. Patients and Methods: Eligible patients had stage III to IV or recurrent disease. Participants were randomized 1:1 to receive C/P for six cycles ± T followed by maintenance T until progression or toxicity. Progression-free survival (PFS) was the primary endpoint; overall survival (OS) and toxicity were secondary endpoints. Results: Sixty-one patients were randomized. After a median-follow-up of 25.9 months, 43 progressions and 38 deaths occurred among 58 evaluable patients. Updated median-PFS continued to favor the T-arm, with medians of 8.0 months versus 12.9 months in the control and T-arms (HR = 0.46; 90% CI, 0.28–0.76; P = 0.005). Median-PFS was 9.3 months versus 17.7 months among 41 patients with stage III to IV disease undergoing primary treatment (HR = 0.44; 90% CI, 0.23–0.83; P = 0.015), and 7.0 months versus 9.2 months among 17 patients with recurrent disease (HR = 0.12; 90% CI, 0.03–0.48; P = 0.004). OS was higher in the T compared with the control arm, with medians of 29.6 months versus 24.4 months (HR = 0.58; 90% CI, 0.34–0.99; P = 0.046). The benefit was most notable in those with stage III to IV disease, with survival median not reached in the T-arm versus 24.4 months in the control arm (HR = 0.49; 90% CI, 0.25–0.97; P = 0.041). Toxicity was not different between arms. Conclusions: Addition of T to C/P increased PFS and OS in women with advanced/recurrent HER2/Neu-positive USC, with the greatest benefit seen for the treatment of stage III to IV disease.

Linked Investigators

Dana M. Roque

Eric Siegel

Floor Backes

Nicole Nevadunsky

Paul Celano