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

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.