A Multicenter Trial to Measure Early Patterns of Change in [18F]-Fluorodeoxyglucose Uptake by PET/CT in Relapsed Ovarian Cancer Patients
Phase 1
35 Years
N/A
35 Years
N/A
Not Enrolling
Female
Ovarian Cancer, Primary Peritoneal Cancer, Fallopian Tube Cancer
Female
Ovarian Cancer, Primary Peritoneal Cancer, Fallopian Tube Cancer
Trial Information
A Multicenter Trial to Measure Early Patterns of Change in [18F]-Fluorodeoxyglucose Uptake by PET/CT in Relapsed Ovarian Cancer Patients
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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
Outcome Time Frame:
Baseline, Week 3, Week 6
Safety Issue:
No
Principal Investigator
Medical Monitor
Investigator Role:
Study Director
Investigator Affiliation:
Merck
Authority:
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study ID:
2009_632
NCT ID:
NCT00959582
Start Date:
October 2009
Completion Date:
October 2011
Related Keywords:
- Ovarian Cancer
- Primary Peritoneal Cancer
- Fallopian Tube Cancer
- Relapsed ovarian cancer
- Ovarian Neoplasms
- Peritoneal Neoplasms
- Fallopian Tube Neoplasms
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