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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00959582
First received: August 12, 2009
Last updated: February 14, 2014
Last verified: February 2014

August 12, 2009
February 14, 2014
September 2009
October 2011   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
  • Progression free proportion [ Time Frame: 40 Weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00959582 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Positron Emission Tomography/Computed Tomography (PET/CT) in Relapsed Ovarian Cancer (MK-0000-143)
A Multicenter Trial to Measure Early Patterns of Change in [18F]-Fluorodeoxyglucose Uptake by PET/CT in Relapsed Ovarian Cancer Patients

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Ovarian Cancer
  • Primary Peritoneal Cancer
  • Fallopian Tube Cancer
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.
Experimental: 1
18-F-FDG PET/CT imaging
Intervention: Procedure: Comparator: 18-F-FDG PET/CT and Volumetric CT
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
October 2011
October 2011   (final data collection date for primary outcome measure)

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
Female
35 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00959582
0000-143, 2009_632
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP