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Topotecan Plus Paclitaxel and Carboplatin in the Initial Treatment of Advanced Ovarian and Primary Peritoneal Carcinoma

Primary Purpose

Ovary Cancer

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Topotecan
Paclitaxel
Carboplatin
Sponsored by
SCRI Development Innovations, LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovary Cancer focused on measuring Ovary Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: To be included in this study, you must meet the following criteria: Epithelial ovarian carcinoma or primary peritoneal carcinoma Willing to consider second-look surgery to evaluate response if necessary No previous treatment with chemotherapy or radiation therapy Ability to perform activities of daily living with minimal assistance Adequate bone marrow, liver and kidney function Written informed consent Exclusion Criteria: You cannot participate in this study if any of the following apply to you: Age < 18 years Brain metastases Recent history of significant heart disease within 6 months Other significant medical conditions Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Overall response rate

    Secondary Outcome Measures

    Overall toxicity

    Full Information

    First Posted
    September 12, 2005
    Last Updated
    May 2, 2011
    Sponsor
    SCRI Development Innovations, LLC
    Collaborators
    GlaxoSmithKline
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00193297
    Brief Title
    Topotecan Plus Paclitaxel and Carboplatin in the Initial Treatment of Advanced Ovarian and Primary Peritoneal Carcinoma
    Official Title
    A Phase II Study of a Three-Day Schedule of Topotecan Plus Paclitaxel and Carboplatin on Day Three in the Initial Treatment of Advanced Ovarian and Primary Peritoneal Carcinoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2002 (undefined)
    Primary Completion Date
    June 2005 (Actual)
    Study Completion Date
    June 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    SCRI Development Innovations, LLC
    Collaborators
    GlaxoSmithKline

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the feasibility and toxicity of the combination of paclitaxel, carboplatin, and topotecan in patients with previously untreated, stage III or IV epithelial ovarian carcinoma or primary peritoneal carcinoma. We will also make a preliminary evaluation of the efficacy of this three drug regimen in the initial treatment of these patients.
    Detailed Description
    Upon determination of eligibility, all patients will be receive: Paclitaxel + Carboplatin + Topotecan a maximum of six courses of chemotherapy will be given at 21 day intervals

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ovary Cancer
    Keywords
    Ovary Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    50 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Topotecan
    Intervention Type
    Drug
    Intervention Name(s)
    Paclitaxel
    Intervention Type
    Drug
    Intervention Name(s)
    Carboplatin
    Primary Outcome Measure Information:
    Title
    Overall response rate
    Secondary Outcome Measure Information:
    Title
    Overall toxicity

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: To be included in this study, you must meet the following criteria: Epithelial ovarian carcinoma or primary peritoneal carcinoma Willing to consider second-look surgery to evaluate response if necessary No previous treatment with chemotherapy or radiation therapy Ability to perform activities of daily living with minimal assistance Adequate bone marrow, liver and kidney function Written informed consent Exclusion Criteria: You cannot participate in this study if any of the following apply to you: Age < 18 years Brain metastases Recent history of significant heart disease within 6 months Other significant medical conditions Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Anthony Greco, MD
    Organizational Affiliation
    SCRI Development Innovations, LLC
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Topotecan Plus Paclitaxel and Carboplatin in the Initial Treatment of Advanced Ovarian and Primary Peritoneal Carcinoma

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