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

NCT ID: NCT00959582

Last Updated: 2015-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2011-10-31

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.

Conditions

Ovarian Cancer; Primary Peritoneal Cancer; Fallopian Tube Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

1

18-F-FDG PET/CT imaging

Group Type: EXPERIMENTAL

Comparator: 18-F-FDG PET/CT and Volumetric CT

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

2009_632

Identifier Type: -

Identifier Source: secondary_id

0000-143

Identifier Type: -

Identifier Source: org_study_id