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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


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
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