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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 January 2017 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: January 23, 2017
Last verified: January 2017
  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
Intervention Model: Parallel Assignment
Masking: No masking
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 ]
    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 ]
    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
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

Ages Eligible for Study:   Child, Adult, Senior
Sexes 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
University of Arizona Cancer Center Active, not recruiting
Tucson, Arizona, United States, 85724
United States, California
John Muir Clinical Research Center Active, not recruiting
Concord, California, United States, 94520
University of California at Los Angeles Withdrawn
Los Angeles, California, United States, 90095
United States, Colorado
Penrose St. Francis Hospital Active, not recruiting
Colorado Springs, Colorado, United States, 80907
United States, Connecticut
The Hospital of Central Connecticut Completed
New Britain, Connecticut, United States, 06050
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, Maryland
Greater Baltimore Medical Center Active, not recruiting
Baltimore, Maryland, United States, 21204
Walter Reed National Military Medical Center Active, not recruiting
Bethesda, Maryland, United States, 20889-5600
University of Maryland Medical Center Active, not recruiting
Silver Spring, Maryland, United States, 20910
United States, New Jersey
Jersey Shore University Medical Center Active, not recruiting
Neptune, New Jersey, United States, 07753
United States, New York
Montefiore Medical Center Active, not recruiting
Bronx, New York, United States, 10461
United States, North Carolina
Duke University School of Medicine Active, not recruiting
Durham, North Carolina, United States, 27710
United States, Ohio
Cleveland Clinic Active, not recruiting
Cleveland, Ohio, United States, 44195
The Ohio State University Active, not recruiting
Hilliard, Ohio, United States, 43026
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: January 23, 2017

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

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

ClinicalTrials.gov processed this record on February 20, 2017