Ovarian CancerPhase 1NCT00959582
Positron Emission Tomography/Computed Tomography (PET/CT) in Relapsed Ovarian Cancer (MK-0000-143)
A Phase 1 study testing Comparator: 18-F-FDG PET/CT and Volumetric CT in people with Ovarian Cancer and Primary Peritoneal Cancer, run by Merck Sharp & Dohme LLC.
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. Read more about this study
- Who is it for?
- Ages 35 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Primary Peritoneal Cancer, Fallopian Tube Cancer
- What is being tested?
- Comparator: 18-F-FDG PET/CT and Volumetric CT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Sep 2009to Oct 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: A Multicenter Trial to Measure Early Patterns of Change in [18F]-Fluorodeoxyglucose Uptake by PET/CT in Relapsed Ovarian Cancer Patients
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.
- Being tested
- Comparator: 18-F-FDG PET/CT and Volumetric CT
- Keywords
- Relapsed ovarian cancer
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparator: 18-F-FDG PET/CT and Volumetric CTProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 18-F-FDG PET/CT imaging Receives: Procedure: Comparator: 18-F-FDG PET/CT and Volumetric CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, Week 3, Week 6
Progression free proportion
Measured: 40 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2009 (estimated)
- Study startSep 2009
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00959582
- Sponsor's protocol ID
- 0000-143
- Other IDs
- 2009_632
- Status last verified
- Jan 2015
- First submitted
- 12 Aug 2009
- Last updated
- 22 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Trial to Measure Early Patterns of Change in [18F]-Fluorodeoxyglucose Uptake by PET/CT in Relapsed Ovarian Cancer Patients
- ClinicalTrials.gov ID
- NCT00959582
- Acronym / sponsor ID
- 0000-143
- Keywords
- Relapsed ovarian cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 14 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Comparator: 18-F-FDG PET/CT and Volumetric CT18-F-FDG PET/CT imaging |
Who may qualify
- Ages
- 35 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comparator: 18-F-FDG PET/CT and Volumetric CTPatients 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. | Procedure or surgery | 1 |
Primary outcome
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
Progression free proportion
Time frame: 40 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Comparator: 18-F-FDG PET/CT and Volumetric CT in people with Ovarian Cancer and Primary Peritoneal Cancer, run by Merck Sharp & Dohme LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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 (time frame: Baseline, Week 3, Week 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2015.