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Positron Emission Tomography/Computed Tomography (PET/CT) in Relapsed Ovarian Cancer (MK-0000-143)

Primary Purpose

Ovarian Cancer, Primary Peritoneal Cancer, Fallopian Tube Cancer

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Comparator: 18-F-FDG PET/CT and Volumetric CT
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ovarian Cancer focused on measuring Relapsed ovarian cancer

Eligibility Criteria

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

Inclusion Criteria:

  • Patient has ovarian, primary peritoneal, or fallopian tube cancer
  • Patient has first or subsequent relapse
  • Patient has had at least on prior platinum-based treatment for ovarian cancer
  • Patient is scheduled to receive treatment with carboplatin or cisplatin monotherapy or combination where one of the drugs is a platinum
  • Patient is not pregnant

Exclusion Criteria:

  • Patient has had abdominal surgery within the last 6 weeks
  • Patient has life expectancy < 6 months
  • Patient has had radiotherapy to the abdomen or pelvis within the last 6 months
  • Patient has poorly controlled diabetes

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    1

    Arm Description

    18-F-FDG PET/CT imaging

    Outcomes

    Primary Outcome Measures

    Proportion of patients with metabolic non-response assessed by FDG-PET standardized uptake value (SUV) 3 weeks and 6 weeks after starting platinum-based therapy
    Progression free proportion

    Secondary Outcome Measures

    Full Information

    First Posted
    August 12, 2009
    Last Updated
    January 21, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00959582
    Brief Title
    Positron Emission Tomography/Computed Tomography (PET/CT) in Relapsed Ovarian Cancer (MK-0000-143)
    Official Title
    A Multicenter Trial to Measure Early Patterns of Change in [18F]-Fluorodeoxyglucose Uptake by PET/CT in Relapsed Ovarian Cancer Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2009 (undefined)
    Primary Completion Date
    October 2011 (Actual)
    Study Completion Date
    October 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study will characterize FDG-PET (18F-Fluorodeoxyglucose-Positron Emission Tomography) as an early response marker in recurrent, platinum-sensitive ovarian cancer treated with platinum-based therapy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ovarian Cancer, Primary Peritoneal Cancer, Fallopian Tube Cancer
    Keywords
    Relapsed ovarian cancer

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    42 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    18-F-FDG PET/CT imaging
    Intervention Type
    Procedure
    Intervention Name(s)
    Comparator: 18-F-FDG PET/CT and Volumetric CT
    Intervention Description
    Patients will receive standard-of-care therapy (carboplatin or cisplatin monotherapy, or a two-drug combination where one is platinum). FDG-PET/CT scans will be performed at baseline following enrollment, after Cycles 1 and 2 of chemotherapy, and if patients are progression-free at the end of Cycle 6. Volumetric CT scans will be performed at baseline following enrollment, after Cycles 1 and 2 of chemotherapy, after Cycle 3 of chemotherapy (optional), and if patients are progression-free at the end of Cycle 6 and at 40 weeks after Cycle 1 dosing.
    Primary Outcome Measure Information:
    Title
    Proportion of patients with metabolic non-response assessed by FDG-PET standardized uptake value (SUV) 3 weeks and 6 weeks after starting platinum-based therapy
    Time Frame
    Baseline, Week 3, Week 6
    Title
    Progression free proportion
    Time Frame
    40 Weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patient has ovarian, primary peritoneal, or fallopian tube cancer Patient has first or subsequent relapse Patient has had at least on prior platinum-based treatment for ovarian cancer Patient is scheduled to receive treatment with carboplatin or cisplatin monotherapy or combination where one of the drugs is a platinum Patient is not pregnant Exclusion Criteria: Patient has had abdominal surgery within the last 6 weeks Patient has life expectancy < 6 months Patient has had radiotherapy to the abdomen or pelvis within the last 6 months Patient has poorly controlled diabetes
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Positron Emission Tomography/Computed Tomography (PET/CT) in Relapsed Ovarian Cancer (MK-0000-143)

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