CarcinomaPhase 1NCT00599755
Phase I Imaging Study Evaluating Gem/Cis or Gem/Carbo for Participants With Non-Small Cell Lung Cancer (MK-0000-083 AM3)
A Phase 1 study testing Comparator: CT or MRI and FDG-PET and Gemcitabine and Cisplatin or Gemcitabine and Carboplatin in people with Carcinoma and Non-small Cell Lung Cancer, run by Merck Sharp & Dohme LLC.
Trial summary
This study will use imaging to look at tumor response to combination chemotherapy of gemcitabine (Gem) and cisplatin (Cis) or gemcitabine and carboplatin (Carbo) in non small cell lung cancer (NSCLC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-small Cell Lung Cancer
- What is being tested?
- Comparator: CT or MRI and FDG-PET and Gemcitabine and Cisplatin or Gemcitabine and Carboplatin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2009to 13 Apr 2011
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has histologically or cytopathologically confirmed metastatic or locally advanced stage IIIB/IV Non-small cell lung cancer (NSCLC)
- Has measurable disease
- Has not been previously treated with surgery (involving the thorax), radiation (unless it was for a metastatic site), or chemotherapy for NSCLC
- Is 18 years of age or older
- Has a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) scale
- Women of childbearing potential have a negative pregnancy test
Who cannot join
- Is participating in or has participated in a study with an investigational compound or device within 30 days or 5 half-lives of the start of treatment
- Has untreated brain metastases related to their NSCLC or carcinomatous meningitis
- Abuses drugs or alcohol
- Is pregnant or breastfeeding
- Is Human Immunodeficiency Virus (HIV) positive
- Has active viral hepatitis
Show all 9Show fewer
- Has hearing loss
- Has poorly controlled diabetes mellitus
- Is allergic to gemcitabine, cisplatin or carboplatin
About this study
Official title: A Multicenter Phase Ib Trial to Measure [18F]-Fluorodeoxyglucose Uptake by Positron Emission Tomography in Stage IIIB and IV Non-Small Cell Lung Cancer Before and After Chemotherapy With Gemcitabine and Cisplatin or Carboplatin
This study will use imaging to look at tumor response to combination chemotherapy of gemcitabine (Gem) and cisplatin (Cis) or gemcitabine and carboplatin (Carbo) in non small cell lung cancer (NSCLC).
- Conditions
- Carcinoma, Non-small Cell Lung Cancer
- Being tested
- Comparator: CT or MRI and FDG-PET, Gemcitabine and Cisplatin or Gemcitabine and Carboplatin
- Medical subject headings
- Carcinoma, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparator: CT or MRI and FDG-PETRadiation
Participants have 4 computed tomography (CT) or magnetic resonance imaging (MRI) scans at screening, baseline, at the end of each treatment cycle (day 21 and day 42.) They also have FDG-PET scans, 2 at Baseline and one at the end of each treatment cycle.
Gemcitabine and Cisplatin or Gemcitabine and CarboplatinDrug
Gemcitabine administered intravenously at a dose of 1000-1250 mg/m^2 on Day 1 and Day 8 of each cycle; Cisplatin administered intravenously at a dose of 60-85 mg/m^2 or Carboplatin at a dose of 4-6 Area Under the Curve (AUC) on Day 1 of each cycle. Two cycles are given 3 weeks apart.
| Study group | Role | What they receive |
|---|---|---|
| Gem/Cis or Gem/Carbo | Experimental | Not described Receives: Radiation: Comparator: CT or MRI and FDG-PET; Drug: Gemcitabine and Cisplatin or Gemcitabine and Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic Response Conversion Rate Between 3 and 6 Weeks After Starting Chemotherapy at a Threshold of a 20% Decrease in SUVmean
Metabolic response conversion rate is the number of participants initially classified as non-metabolic responders relative to baseline at week 3 after starting chemotherapy, who are then, relative to week 3, reclassified as metabolic responders at week 6 after starting chemotherapy, based on a pre-specified threshold of a 20% decrease in mean standardized uptake value (SUVmean) of [18F]-Fluorodeoxyglucose (FDG). The SUVmean was calculated by summing the radioactivity from volumes of interest within each tumor and normalizing for the injected dose and lean body mass.
Measured: Weeks 3 and 6 following chemotherapy
Secondary outcomes (4)
Repeatability of FDG SUVmean at Baseline
Two positron emission tomography (PET) scans are obtained on different days at baseline, as close together as possible, under conditions of no biological change, to measure FDG SUVmean. The SUVmean was calculated by summing the radioactivity from volumes of interest within each tumor and normalizing for the injected dose and lean body mass.
Measured: Between -14 to -6 days and between -5 to 0 days prior to starting chemotherapy
Change in FDG-PET Uptake From Baseline to Week 3
Fold change in SUVmean of FDG uptake with accompanying 80% Confidence Interval. The SUVmean was calculated by summing the radioactivity from volumes of interest within each tumor and normalizing for the injected dose and lean body mass.
Measured: Baseline and Week 3
Change in FDG-PET Uptake From Week 3 to Week 6
Fold change in SUVmean of FDG uptake with accompanying 80% Confidence Interval. The SUVmean was calculated by summing the radioactivity from volumes of interest within each tumor and normalizing for the injected dose and lean body mass.
Measured: Week 3 and Week 6
Change in FGD-PET Uptake From Baseline to Week 6
Fold change in SUVmean of FDG uptake with accompanying 80% Confidence Interval.
The SUVmean was calculated by summing the radioactivity from volumes of interest within each tumor and normalizing for the injected dose and lean body mass.
Measured: Baseline and Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2008 (estimated)
- Study start1 Jan 2009
- Primary completion10 Jun 2010
- Study completion13 Apr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CarcinomaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 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
- NCT00599755
- Sponsor's protocol ID
- 0000-083
- Other IDs
- 2007_662
- Status last verified
- Dec 2017
- First submitted
- 7 Jan 2008
- Last updated
- 16 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Phase Ib Trial to Measure [18F]-Fluorodeoxyglucose Uptake by Positron Emission Tomography in Stage IIIB and IV Non-Small Cell Lung Cancer Before and After Chemotherapy With Gemcitabine and Cisplatin or Carboplatin
- ClinicalTrials.gov ID
- NCT00599755
- Acronym / sponsor ID
- 0000-083
- Conditions
- Carcinoma, Non-small Cell Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2009 (actual)
- Primary completion
- 10 Jun 2010 (actual)
- Study completion
- 13 Apr 2011 (actual)
- First posted
- 24 Jan 2008 (estimated)
- Results
- Posted 27 Jun 2012
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 use imaging to look at tumor response to combination chemotherapy of gemcitabine (Gem) and cisplatin (Cis) or gemcitabine and carboplatin (Carbo) in non small cell lung cancer (NSCLC).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gem/Cis or Gem/Carbo | Experimental | Radiation: Comparator: CT or MRI and FDG-PET, Drug: Gemcitabine and Cisplatin or Gemcitabine and Carboplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Has histologically or cytopathologically confirmed metastatic or locally advanced stage IIIB/IV Non-small cell lung cancer (NSCLC)
- Has measurable disease
- Has not been previously treated with surgery (involving the thorax), radiation (unless it was for a metastatic site), or chemotherapy for NSCLC
- Is 18 years of age or older
- Has a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) scale
Key exclusion criteria (9 listed)
- Is participating in or has participated in a study with an investigational compound or device within 30 days or 5 half-lives of the start of treatment
- Has untreated brain metastases related to their NSCLC or carcinomatous meningitis
- Abuses drugs or alcohol
- Is pregnant or breastfeeding
- Is Human Immunodeficiency Virus (HIV) positive
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: CT or MRI and FDG-PETParticipants have 4 computed tomography (CT) or magnetic resonance imaging (MRI) scans at screening, baseline, at the end of each treatment cycle (day 21 and day 42.) They also have FDG-PET scans, 2 at Baseline and one at the end of each treatment cycle. | Radiation | Gem/Cis or Gem/Carbo |
| Gemcitabine and Cisplatin or Gemcitabine and CarboplatinGemcitabine administered intravenously at a dose of 1000-1250 mg/m^2 on Day 1 and Day 8 of each cycle; Cisplatin administered intravenously at a dose of 60-85 mg/m^2 or Carboplatin at a dose of 4-6 Area Under the Curve (AUC) on Day 1 of each cycle. Two cycles are given 3 weeks apart. | Drug | Gem/Cis or Gem/Carbo |
Primary outcome
Metabolic Response Conversion Rate Between 3 and 6 Weeks After Starting Chemotherapy at a Threshold of a 20% Decrease in SUVmean
Time frame: Weeks 3 and 6 following chemotherapy
Metabolic response conversion rate is the number of participants initially classified as non-metabolic responders relative to baseline at week 3 after starting chemotherapy, who are then, relative to week 3, reclassified as metabolic responders at week 6 after starting chemotherapy, based on a pre-specified threshold of a 20% decrease in mean standardized uptake value (SUVmean) of [18F]-Fluorodeoxyglucose (FDG). The SUVmean was calculated by summing the radioactivity from volumes of interest within each tumor and normalizing for the injected dose and lean body mass.
4 secondary outcomes
Repeatability of FDG SUVmean at Baseline
Time frame: Between -14 to -6 days and between -5 to 0 days prior to starting chemotherapy
Change in FDG-PET Uptake From Baseline to Week 3
Time frame: Baseline and Week 3
Change in FDG-PET Uptake From Week 3 to Week 6
Time frame: Week 3 and Week 6
Change in FGD-PET Uptake From Baseline to Week 6
Time frame: Baseline and Week 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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: CT or MRI and FDG-PET and Gemcitabine and Cisplatin or Gemcitabine and Carboplatin in people with Carcinoma and Non-small Cell Lung 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 6 inclusion and 9 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 16 Jan 2018. 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?
Yes. Results are posted in the registry (first posted 27 Jun 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Metabolic Response Conversion Rate Between 3 and 6 Weeks After Starting Chemotherapy at a Threshold of a 20% Decrease in SUVmean (time frame: Weeks 3 and 6 following chemotherapy). 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 16 Jan 2018.