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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01367002
Recruitment Status : Completed
First Posted : June 6, 2011
Results First Posted : April 18, 2023
Last Update Posted : May 17, 2023
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Yale University

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).

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : June 2011
Actual Primary Completion Date : June 30, 2022
Actual Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Progression Free Survival Differences Between Treatment Arms. [ Time Frame: 6 years ]
    Progression free survival differences between treatment arms.


Secondary Outcome Measures :
  1. To Assess the Safety Profile of Trastuzumab in USPC Patients by CTCAE v4.0 [ Time Frame: 6 years ]
    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.

  2. To Assess Objective Response Rate (ORR) [ Time Frame: 6 years ]
    To assess objective response rate (ORR)

  3. To Assess Overall Survival (OS) [ Time Frame: 6 years ]
    To assess overall survival (OS), presented are the number of participants that survived through the duration of the study period.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01367002


Locations
Show Show 20 study locations
Sponsors and Collaborators
Yale University
Genentech, Inc.
Investigators
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Principal Investigator: Alessandro D Santin, M.D. Yale University
  Study Documents (Full-Text)

Documents provided by Yale University:
Publications of Results:
Other Publications:

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01367002    
Other Study ID Numbers: 1012007786
First Posted: June 6, 2011    Key Record Dates
Results First Posted: April 18, 2023
Last Update Posted: May 17, 2023
Last Verified: May 2023
Keywords provided by Yale University:
Uterine serous papillary carcinoma
Type II endometrial cancer
HER2/neu
Paclitaxel, Carboplatin, Trastuzumab
Additional relevant MeSH terms:
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Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Diseases
Paclitaxel
Carboplatin
Trastuzumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological