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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by Yale University
Genentech, Inc.
Information provided by (Responsible Party):
Yale University Identifier:
First received: May 26, 2011
Last updated: April 7, 2016
Last verified: April 2016
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).

Condition Intervention Phase
Endometrial Cancer
Drug: Carboplatin/Paclitaxel
Drug: Trastuzumab
Phase 2

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

Resource links provided by NLM:

Further study details as provided by Yale University:

Primary Outcome Measures:
  • Progression free survival differences between Arm A versus Arm B. [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    Progression free survival differences between Arm A versus Arm B.

Secondary Outcome Measures:
  • To assess the safety profile of trastuzumab in USPC patients by CTCAE v4.0 [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    To assess the safety profile of trastuzumab in USPC patients by CTCAE v4.0.

Estimated Enrollment: 100
Study Start Date: June 2011
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: July 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Carboplatin/Paclitaxel
Drug: Carboplatin/Paclitaxel
Paclitaxel 175 mg/m2 will administered intravenously every 21 days for 6 cycles. Carboplatin AUC 5 will be administered intravenously every 21 days for 6 cycles. 100% of patients will receive Carboplatin/Paclitaxel.
Other Names:
  • Taxus brevifolia
  • cis-Diammine
Experimental: Trastuzumab
Monoclonal antibody
Drug: Trastuzumab
Paclitaxel 175 mg/m2 will be administered intravenously every 21 days for 6 cycles. Carboplatin AUC 5 will be administered intravenously every 21 days for 6 cycles. On day 1, an 8 mg/kg loading dose of trastuzumab will be administered over a 90 minute period. Beginning on day 21, patients will receive 6mg/kg of trastuzumab, administered intravenously every 21 days and continued indefinitely every 21 days after 6 cycles of cytotoxic therapy are completed and until progression of the disease or prohibitive toxicities occur. 50% of patients will receive Carboplatin/Paclitaxel with the addition of Trastuzumab.
Other Name: Herceptin

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.

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01367002

Contact: Alessandro D Santin, M.D. 203-737-4450
Contact: Martha Luther, R.N. 203-737-2781

United States, Arizona
University of Arizona Cancer Center Recruiting
Tucson, Arizona, United States, 85724
Contact: Setsuko Chambers, M.D.    520-626-0950   
Contact: Katherine Center    520-626-9283   
Principal Investigator: Setsuko Chambers, M.D.         
United States, California
John Muir Clinical Research Center Recruiting
Concord, California, United States, 94520
Contact: Babak Edraki, M.D.    925-674-2580   
Contact: Peggy Newsom    925-674-2198   
Principal Investigator: Babak Edraki, M.D.         
University of California at Los Angeles Not yet recruiting
Los Angeles, California, United States, 90095
Contact: Gottfried Konecny, M.D.    310-586-2652   
Contact: Christy Palodichuk         
Principal Investigator: Gottfried Konecny, M.D.         
United States, Colorado
Penrose St. Francis Hospital Recruiting
Colorado Springs, Colorado, United States, 80907
Contact: Dirk Pikkaart, M.D.    719-776-6222   
Contact: Cynthia Winemiller    719-776-6222   
Principal Investigator: Dirk Pikkaart, M.D.         
United States, Connecticut
The Hospital of Central Connecticut Recruiting
New Britain, Connecticut, United States, 06050
Contact: Amy Brown, M.D.    860-826-1101   
Contact: Siobhan Reilly, CCRP    860-224-5900 ext 6718   
Sub-Investigator: James Hoffman, M.D.         
Smilow Cancer Hospital at Yale New Haven Recruiting
New Haven, Connecticut, United States, 06510
Contact: Alessandro D Santin, M.D.    203-737-4450   
Contact: Martha Luther, R.N.    203-737-2781   
Principal Investigator: Alessandro Santin, M.D.         
United States, Maryland
Greater Baltimore Medical Center Recruiting
Baltimore, Maryland, United States, 21204
Contact: Amanda Nickles-Fader, M.D.    443-803-0235   
Contact: Tahisa Hamwright, B.S.    443-849-3123   
Principal Investigator: Amanda Nickles-Fader, M.D.         
Walter Reed National Military Medical Center Recruiting
Bethesda, Maryland, United States, 20889-5600
Contact: William J. Lowery, M.D.    301-400-1271   
Contact: Jannette McIntosh    301-400-1301   
Principal Investigator: William J. Lowery, M.D.         
University of Maryland Medical Center Recruiting
Silver Spring, Maryland, United States, 20910
Contact: Dana Roque, M.D.    301-754-7552   
Contact: Carolyn Harris, B.A.    410-328-8198   
Principal Investigator: Dana Roque, M.D.         
United States, New Jersey
Jersey Shore University Medical Center Recruiting
Neptune, New Jersey, United States, 07753
Contact: Karim El-Sahwi, M.D.    732-776-3790   
Contact: Diane Russomanno    732-776-3790   
Principal Investigator: Karim El-Sahwi, M.D.         
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10461
Contact: June Hou, M.D.    718-405-8082   
Contact: Randy Teeter    718-405-8395   
Principal Investigator: June Hou, M.D.         
United States, North Carolina
Duke University School of Medicine Recruiting
Durham, North Carolina, United States, 27710
Contact: Laura J. Havrilesky, M.D.    919-684-3765   
Contact: Sonja G. Hunter, AAS    919-684-9074   
Principal Investigator: Laura J Havrilesky, M.D.         
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Peter Rose, MD    216-444-8551   
Contact: Donna White, RN    216-444-3414   
Principal Investigator: Peter Rose, MD         
The Ohio State University Recruiting
Hilliard, Ohio, United States, 43026
Contact: David O'Malley, M.D.    614-293-7642    david.o'   
Contact: Michele Vaughan, B.S.    614-366-9088   
Principal Investigator: David O'Malley, M.D.         
Sponsors and Collaborators
Yale University
Genentech, Inc.
Principal Investigator: Alessandro D Santin, M.D. Yale University
  More Information


Responsible Party: Yale University Identifier: NCT01367002     History of Changes
Other Study ID Numbers: 1012007786 
Study First Received: May 26, 2011
Last Updated: April 7, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
Uterine serous papillary carcinoma
Type II endometrial cancer
Paclitaxel, Carboplatin, Trastuzumab

Additional relevant MeSH terms:
Endometrial Neoplasms
Carcinoma, Papillary
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Albumin-Bound Paclitaxel
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action processed this record on October 27, 2016