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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Yale University
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01367002
First received: May 26, 2011
Last updated: October 10, 2014
Last verified: October 2014
  Purpose

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 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Carboplatin/Paclitaxel
Chemotherapy
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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  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 ClinicalTrials.gov identifier: NCT01367002

Contacts
Contact: Alessandro D Santin, M.D. 203-737-4450 alessandro.santin@yale.edu
Contact: Martha Luther, R.N. 203-737-2781 martha.luther@yale.edu

Locations
United States, Arizona
St. Joseph's Hospital and Medical Center Recruiting
Pheonix, Arizona, United States, 85013
Contact: Dana Chase, M.D.    602-406-7730    dana.chase@dignityhealth.org   
Contact: Kelli Williamson, RN, MPH    602-406-689    kelli.williamson@dignityhealth.org   
Principal Investigator: Dana Chase, M.D.         
University of Arizona Cancer Center Recruiting
Tucson, Arizona, United States, 85724
Contact: Setsuko Chambers, M.D.    520-626-0950    schambers@uacc.arizona.edu   
Contact: Katherine Center    520-626-9283    kcenter@uacc.arizona.edu   
Principal Investigator: Setsuko Chambers, M.D.         
University of Arizona Cancer Center Recruiting
Tucson, Arizona, United States, 85704
Contact: Setsuko Chambers, M.D.    520-626-9283    schambers@uacc.arizona.edu   
Contact: Katherine Center    520-626-9283    kcenter@uacc.arizona.edu   
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    babak.edraki@johnmuirhealth.com   
Contact: Peggy Newsom    925-674-2198    peggy.newsom@johhmuirhealth.com   
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    gkonecny@mednet.ucla.edu   
Contact: Christy Palodichuk         
Principal Investigator: Gottfried Konecny, M.D.         
Women's Cancer Research Foundation Recruiting
Newport Beach, California, United States, 92663
Contact: Alberto Mendivil, M.D.    949-642-1361    amendivil@gynoncology.com   
Contact: Katrina Lopez, CCRC    949-642-5165    katrinal@gynoncology.com   
Principal Investigator: Alberto Mendivil, M.D.         
United States, Colorado
Penrose St. Francis Hospital Recruiting
Colorado Springs, Colorado, United States, 80907
Contact: Dirk Pikkaart, M.D.    719-776-6222    pikaartdp@gmail.com   
Contact: Cynthia Winemiller    719-776-6222    cynthiawinemiller@centura.org   
Principal Investigator: Dirk Pikkaart, M.D.         
United States, Connecticut
The Hospital of Central Connecticut Recruiting
New Britain, Connecticut, United States, 06050
Contact: James Hoffman, M.D.    860-826-1101    james.hoffman@hhchealth.org   
Contact: Siobhan Reilly, CCRP    860-224-5900 ext 6718    siobhan.reilly@hhchealth.org   
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    alessandro.santin@yale.edu   
Contact: Martha Luther, R.N.    203-737-2781    martha.luther@yale.edu   
Principal Investigator: Alessandro Santin, M.D.         
United States, Illinois
The University of Chicago Medicine Recruiting
Chicago, Illinois, United States, 60637
Contact: Gini Fleming, M.D.    773-702-6712    gfleming@medicine.bsd.uchicago.edu   
Contact: Tiffany Parks, BS, CRA    773-834-2643    tparks@bsd.uchicago.edu   
Principal Investigator: Gini Fleming, M.D.         
United States, Maryland
Greater Baltimore Medical Center Recruiting
Baltimore, Maryland, United States, 21204
Contact: Amanda Nickles-Fader, M.D.    443-803-0235    amandafader@gmail.com   
Contact: Tahisa Hamwright, B.S.    443-849-3123    thamwright@gbmc.org   
Principal Investigator: Amanda Nickles-Fader, M.D.         
Walter Reed National Military Medical Center Recruiting
Bethesda, Maryland, United States, 20889-5600
Contact: Michael P. Stany, M.D.    301-400-1258    michael.stany@med.navy.mil   
Contact: Jannette McIntosh    301-400-1307    jannette.j.mcintosh.civ@health.mil   
Principal Investigator: Michael P. Stany, M.D.         
Holy Cross Hospital Not yet recruiting
Silver Springs, Maryland, United States, 20910
Contact: Cheryl Aylesworth, M.D.    301-754-7552    cheryl.aylesworth@gmail.com   
Contact: Lyudmila Kalnitskaya    301-754-7552    kalnitsl@holycrosshealth.org   
Principal Investigator: Cheryl Aylesworth, 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    kelsahwi@meridianhealth.com   
Contact: Diane Russomanno    732-776-3790    drussomanno@meridianhealth.com   
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    yhou@montefiore.org   
Contact: Randy Teeter    718-405-8395    rteeter@montefiore.org   
Principal Investigator: June Hou, M.D.         
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27514
Contact: Paola Gehrig, M.D.    919-966-2131    paola_gehrig@med.unc.edu   
Contact: Ellen M. Cohen, Ph.D.    919-843-2448    ellen_cohen@med.unc.edu   
Principal Investigator: Paola Gehrig, M.D.         
Duke University School of Medicine Recruiting
Durham, North Carolina, United States, 27710
Contact: Laura J. Havrilesky, M.D.    919-684-3765    laura.havrilesky@duke.edu   
Contact: Sonja G. Hunter, AAS    919-684-9074    sonja.hunter@duke.edu   
Principal Investigator: Laura J Havrilesky, M.D.         
United States, Ohio
The Ohio State University Recruiting
Hilliard, Ohio, United States, 43026
Contact: David O'Malley, M.D.    614-293-7642    david.o'malley@osumc.edu   
Contact: Michele Vaughan, B.S.    614-366-9088    michele.vaughan@osumc.edu   
Principal Investigator: David O'Malley, M.D.         
Sponsors and Collaborators
Yale University
Genentech, Inc.
Investigators
Principal Investigator: Alessandro D Santin, M.D. Yale University
  More Information

Publications:

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01367002     History of Changes
Other Study ID Numbers: 1012007786
Study First Received: May 26, 2011
Last Updated: October 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
Uterine serous papillary carcinoma
Type II endometrial cancer
HER2/neu
Paclitaxel, Carboplatin, Trastuzumab

Additional relevant MeSH terms:
Trastuzumab
Carcinoma, Papillary
Carcinoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell
Carboplatin
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 21, 2014