Brief Title
Evaluation of Carboplatin/Paclitaxel With and Without Trastuzumab (Herceptin) in Uterine Serous Cancer
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
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 Phase
Phase 2
Study Type
Interventional
Primary Outcome
Progression free survival differences between Arm A versus Arm B.
Secondary Outcome
To assess the safety profile of trastuzumab in USPC patients by CTCAE v4.0
Condition
Endometrial Cancer
Intervention
Carboplatin/Paclitaxel
Study Arms / Comparison Groups
Carboplatin/Paclitaxel
Description: Chemotherapy
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
61
Start Date
June 2011
Completion Date
December 2020
Primary Completion Date
December 2020
Eligibility Criteria
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.
Gender
Female
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Alessandro D Santin, M.D., ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01367002
Organization ID
1012007786
Responsible Party
Sponsor
Study Sponsor
Yale University
Collaborators
Genentech, Inc.
Study Sponsor
Alessandro D Santin, M.D., Principal Investigator, Yale University
Verification Date
April 2020