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

Phase 1

Completed

• Conditions: Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cancer

• Registration Number: NCT00959582
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-08-12
• Study First Submitted QC: 2009-08-13
• Study First Posted: 2009-08-14
• Study Start: 2009-09
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-21
• Last Update Posted: 2015-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 42

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Progression free proportion	40 Weeks
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	Baseline, Week 3, Week 6