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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:
Merck
ClinicalTrials.gov Identifier:
NCT00959582
First received: August 12, 2009
Last updated: January 5, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Ovarian Cancer
Primary Peritoneal Cancer
Fallopian Tube Cancer
 Procedure: Comparator: 18-F-FDG PET/CT and Volumetric CT
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Multicenter Trial to Measure Early Patterns of Change in [18F]-Fluorodeoxyglucose Uptake by PET/CT in Relapsed Ovarian Cancer Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • 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 ]

Enrollment: 42
Study Start Date: October 2009
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
18-F-FDG PET/CT imaging
 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.

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00959582

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

Responsible Party: Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00959582     History of Changes
Other Study ID Numbers: 2009_632, 143
Study First Received: August 12, 2009
Last Updated: January 5, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Merck:
Relapsed ovarian cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
 Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Fallopian Tube Diseases

ClinicalTrials.gov processed this record on June 17, 2013