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).
Brief Title
Evaluation of Carboplatin/Paclitaxel With and Without Trastuzumab (Herceptin) in Uterine Serous Cancer
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Endometrial Cancer
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.
* 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.
Inclusion 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
* 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
Gender
Female
Gender Based
false
Keywords
Uterine serous papillary carcinoma
Type II endometrial cancer
HER2/neu
Paclitaxel, Carboplatin, Trastuzumab
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
NCT Id
NCT01367002
Org Class
Other
Org Full Name
Yale University
Org Study Id
1012007786
Overall Status
Completed
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Actual
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
Primary Outcomes
Outcome Description
Progression free survival differences between treatment arms.
Outcome Measure
Progression Free Survival Differences Between Treatment Arms.
Outcome Time Frame
6 years
Secondary Outcomes
Outcome Description
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.
Outcome Time Frame
6 years
Outcome Measure
To Assess the Safety Profile of Trastuzumab in USPC Patients by CTCAE v4.0
Outcome Description
To assess objective response rate (ORR)
Outcome Time Frame
6 years
Outcome Measure
To Assess Objective Response Rate (ORR)
Outcome Description
To assess overall survival (OS), presented are the number of participants that survived through the duration of the study period.
Outcome Time Frame
6 years
Outcome Measure
To Assess Overall Survival (OS)
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Child
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
0
Investigators
Investigator Type
Principal Investigator
Investigator Name
Nicole Nevadunsky
Investigator Email
nnevadun@montefiore.org
Investigator Phone
718-405-8082