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

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: August 12, 2009
Last updated: January 21, 2015
Last verified: January 2015
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 Intervention Phase
Ovarian Cancer
Primary Peritoneal Cancer
Fallopian Tube Cancer
Procedure: Comparator: 18-F-FDG PET/CT and Volumetric CT
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Merck Sharp & Dohme Corp.:

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 [ Time Frame: Baseline, Week 3, Week 6 ]
  • Progression free proportion [ Time Frame: 40 Weeks ]

Enrollment: 42
Study Start Date: September 2009
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


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

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
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Please refer to this study by its identifier: NCT00959582

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

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00959582     History of Changes
Other Study ID Numbers: 0000-143
Study First Received: August 12, 2009
Last Updated: January 21, 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
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases
Fluorodeoxyglucose F18
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017