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



Status:Active, not recruiting
Conditions:Cervical Cancer, Cancer, Endometrial Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:4/17/2018
Start Date:June 2011
End Date:July 2019

Use our guide to learn which trials are right for you!

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

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).

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.
We found this trial at
14
sites
100 Grand St
New Britain, Connecticut 06050
(860) 224-5011
Phone: 860-826-1101
The Hospital of Central Connecticut The Hospital of Central Connecticut is dedicated to fostering, sustaining...
?
mi
from
New Britain, CT
Click here to add this to my saved trials
3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
?
mi
from
Bronx, NY
Click here to add this to my saved trials
9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Peter Rose, MD
Phone: 216-444-8551
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
6701 N Charles St
Baltimore, Maryland 21204
(443) 849-2000
Principal Investigator: Amanda Nickles-Fader, M.D.
Phone: 443-803-0235
Greater Baltimore Medical Center The 255-bed medical center (acute and sub-acute care) is located on...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
8901 Rockville Pike
Bethesda, Maryland 20889
(301) 295-4000
Principal Investigator: William J. Lowery, M.D.
Phone: 301-400-1271
Walter Reed National Military Medical Center The Walter Reed National Military Medical Center is one...
?
mi
from
Bethesda, MD
Click here to add this to my saved trials
Colorado Springs, Colorado 80907
Principal Investigator: Dirk Pikkaart, M.D.
Phone: 719-776-6222
?
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
Concord, California 94520
Principal Investigator: Babak Edraki, M.D.
Phone: 925-674-2580
?
mi
from
Concord, CA
Click here to add this to my saved trials
Durham, North Carolina 27710
Principal Investigator: Laura J Havrilesky, M.D.
Phone: 919-684-3765
?
mi
from
Durham, NC
Click here to add this to my saved trials
Hilliard, Ohio 43026
Principal Investigator: David O'Malley, M.D.
Phone: 614-293-7642
?
mi
from
Hilliard, OH
Click here to add this to my saved trials
Neptune, New Jersey 07754
?
mi
from
Neptune, NJ
Click here to add this to my saved trials
New Haven, Connecticut 06520
Principal Investigator: Alessandro Santin, M.D.
Phone: 203-737-4450
?
mi
from
New Haven, CT
Click here to add this to my saved trials
Silver Spring, Maryland 20910
Principal Investigator: Dana Roque, M.D.
Phone: 301-754-7552
?
mi
from
Silver Spring, MD
Click here to add this to my saved trials
Tucson, Arizona 85724
Principal Investigator: Setsuko Chambers, M.D.
Phone: 520-626-0950
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
Tucson, Arizona 85724
?
mi
from
Tucson, AZ
Click here to add this to my saved trials