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

Ovarian Cancer Clinical Trial

Official title:

A Multicenter Trial to Measure Early Patterns of Change in [18F]-Fluorodeoxyglucose Uptake by PET/CT in Relapsed Ovarian Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00959582
• Other study ID #: 0000-143
• Secondary ID: 2009_632
• Status: Completed
• Phase: Phase 1
• First received: August 12, 2009
• Last updated: January 21, 2015
• Start date: September 2009
• Est. completion date: October 2011

Study information

• Verified date: January 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Fallopian Tube Cancer
• Ovarian Cancer
• Ovarian Neoplasms
• Primary Peritoneal Cancer

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Progression free proportion		40 Weeks	No