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


Phase 2
N/A
N/A
Open (Enrolling)
Female
Endometrial Cancer

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression free survival differences between Arm A versus Arm B.

Outcome Description:

Progression free survival differences between Arm A versus Arm B.

Outcome Time Frame:

4 years

Safety Issue:

Yes

Principal Investigator

Alessandro D Santin, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Yale University

Authority:

United States: Institutional Review Board

Study ID:

1012007786

NCT ID:

NCT01367002

Start Date:

June 2011

Completion Date:

July 2015

Related Keywords:

  • Endometrial Cancer
  • Uterine serous papillary carcinoma
  • Type II endometrial cancer
  • HER2/neu
  • Paclitaxel, Carboplatin, Trastuzumab
  • Endometrial Neoplasms
  • Carcinoma, Papillary
  • Adenoma

Name

Location
St. Joseph's Hospital and Medical Center Phoenix, Arizona  85001-2071
University of Connecticut Health Center Farmington, Connecticut  06360-7106
Montefiore Medical Center Bronx, New York  10467-2490
Greater Baltimore Medical Center Baltimore, Maryland  21204
University of Virginia Charlottesville, Virginia  22908
University of North Carolina Chapel Hill, North Carolina  27599
The Ohio State University Columbus, Ohio  43210
Holy Cross Hospital Silver Spring, Maryland  20910
Jersey Shore University Medical Center Neptune, New Jersey  07754
University of California at Los Angeles Los Angeles, California  90095
Duke University School of Medicine Durham, North Carolina  27710
Smilow Cancer Hospital at Yale New Haven New Haven, Connecticut  06510
John Muir Clinical Research Center Concord, California  94520