Clinical Trials /

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

NCT01367002

Description:

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).

Related Conditions:
  • Endometrial Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Evaluation of <span class="go-doc-concept go-doc-intervention">Carboplatin/Paclitaxel</span> With and Without <span class="go-doc-concept go-doc-intervention">Trastuzumab</span> (<span class="go-doc-concept go-doc-intervention">Herceptin</span>) in Uterine Serous Cancer

Title

  • Brief Title: Evaluation of Carboplatin/Paclitaxel With and Without Trastuzumab (Herceptin) in Uterine Serous Cancer
  • 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
  • Clinical Trial IDs

    NCT ID: NCT01367002

    ORG ID: 1012007786

    Trial Conditions

    Endometrial Cancer

    Trial Interventions

    Drug Synonyms Arms
    Carboplatin/Paclitaxel Taxus brevifolia, cis-Diammine Carboplatin/Paclitaxel
    Trastuzumab Herceptin Trastuzumab

    Trial 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).

    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.

    Trial Arms

    Name Type Description Interventions
    Carboplatin/Paclitaxel Active Comparator Chemotherapy Carboplatin/Paclitaxel
    Trastuzumab Experimental Monoclonal antibody Trastuzumab

    Eligibility 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.

    Minimum Eligible Age: N/A

    Maximum Eligible Age: N/A

    Eligible Gender: Female

    Primary Outcome Measures

    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

    Trial Keywords

    Uterine serous papillary carcinoma

    Type II endometrial cancer

    HER2/neu

    Paclitaxel, Carboplatin, Trastuzumab