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

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ClinicalTrials.gov Identifier: NCT00959582
Recruitment Status : Completed
First Posted : August 14, 2009
Last Update Posted : January 22, 2015
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Primary Peritoneal Cancer Fallopian Tube Cancer Procedure: Comparator: 18-F-FDG PET/CT and Volumetric CT Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Multicenter Trial to Measure Early Patterns of Change in [18F]-Fluorodeoxyglucose Uptake by PET/CT in Relapsed Ovarian Cancer Patients
Study Start Date : September 2009
Primary Completion Date : October 2011
Study Completion Date : October 2011


Arms and Interventions

Arm Intervention/treatment
Experimental: 1
18-F-FDG PET/CT imaging
Procedure: Comparator: 18-F-FDG PET/CT and Volumetric CT
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.


Outcome Measures

Primary Outcome Measures :
  1. 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 ]
  2. Progression free proportion [ Time Frame: 40 Weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations

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): NCT00959582


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00959582     History of Changes
Other Study ID Numbers: 0000-143
2009_632
First Posted: August 14, 2009    Key Record Dates
Last Update Posted: January 22, 2015
Last Verified: January 2015

Keywords provided by Merck Sharp & Dohme Corp.:
Relapsed ovarian cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action