NSCLCPhase 1/2NCT02175381
Carboplatin Plus Gemcitabine for Elderly Patients With Stage IV NSCLC
A Phase 1/2 study testing Carboplatin and Gemcitabine in people with NSCLC, run by Hellenic Oncology Research Group at 5 sites in Greece.
Trial summary
The investigators propose to study the safety and efficacy of the combination of Carboplatin plus Gemcitabine in a Phase I/II trial of elderly subjects with non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- NSCLC
- What is being tested?
- Carboplatin and Gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 5 sitesGreece
- Study dates
- Feb 2011to Apr 2014
- Phase
- Phase 1/2
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥70 years old
- Cytologically or histologically documented NSCLC
- Measurable disease according to Response Evaluation Criteria in Solid Tumors (at least one measurable lesion)
- World Health Organisation (WHO) performance status 0-2
- Non-frail patients according to Comprehensive Geriatric Assessment
- Previously treated NSCLC (or patients for whom the combination is considered adequate treatment) (for phase I part)
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- No prior chemotherapy (for phase II part)
- Life expectancy of at least 12 weeks
- Serum bilirubin less than 1.5 times the upper normal limit
- Aspartate Aminotransferase and Alanine Aminotransferase less than 2.5 times the upper normal limit in the absence of demonstrable liver metastases, or less than 5 times the upper normal limit in the presence of liver metastases
- Serum creatinine less than 1.5 times the upper normal limit and Creatinine Clearance >60 ml/min
- Neutrophil count more than 1.5x 109 /L
- Platelet count more than 100x 109 /L
- Before patient enrollment, written informed consent must be given according to Good Clinical Practice guidelines and national/local regulations.
Who cannot join
- Hemoptysis
- Central nervous system metastases
- Clinically significant cardiovascular disease
- Medically uncontrolled hypertension
- Other co-existing malignancies or malignancies diagnosed within the last 5 years (with the exception of basal cell carcinoma or cervical cancer in situ)
- Any evidence of severe uncontrolled concomitant disease (in the opinion of the investigator)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Greece5 sites
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
Athens
401 Military Hospital of Athens
Athens
Air Forces Military Hospital of Athens Athens, Greece
Athens
Medical Oncology Unit NIMTS (Veterans Hospital)
Athens
University Hospital of Crete, Dep of Medical Oncology Heraklion, Greece
Heraklion, Crete
About this study
Official title: A Phase I/II Trial of the Carboplatin/Gemcitabine Combination as First Line Treatment for Elderly Patients With Stage IV NSCLC.
The investigators propose to study the safety and efficacy of the combination of Carboplatin plus Gemcitabine in a Phase I/II trial of elderly subjects with non-small cell lung cancer.
Read the detailed description
About 50% of newly diagnosed cases of NSCLC concern patients older than 65 years, while 30-40% of cases are diagnosed in patients older than 70 years. Furthermore, recent data suggest that during the last decade, the incidence and mortality of NSCLC has decreased in younger patients, while it has increased among older patients. Based on these observations, it becomes clear that NSCLC represents a significant health problem in elderly patients. However, elderly patients are frequently underrepresented in clinical trials evaluating new treatments in NSCLC. Indeed, more than 75% of patients older than 65 years with metastatic NSCLC never receive any kind of chemotherapy in the daily clinical practice.
In elderly patients there is lack of prospective data regarding the role of platinum-based doublets. It is not clear whether elderly patients gain any survival benefit or not from platinum-based doublets and whether these chemotherapeutic regimens result in a significant increase in toxicity.
There is a clear need to prospectively evaluate the tolerability and efficacy of platinum-based doublets as first-line chemotherapy for older NSCLC patients.
On this basis it would be very interesting to initiate a phase I/II study with gemcitabine/carboplatin combination as first line treatment in older NSCLC patients.
- Conditions
- NSCLC
- Being tested
- Carboplatin, Gemcitabine
- Keywords
- Metastatic NSCLC, Elderly, 1st Line, Platinum-based treatment
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarboplatinDrug
Carboplatin: 2.5 AUC i.v on day 1. Cycle repeated ever 2 weeks
GemcitabineDrug
Gemcitabine: 1100 mg/m2, iv on day 1. Cycle repeated every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Carbo/GEM | Experimental | Not described Receives: Drug: Carboplatin; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate
Measured: Disease evaluation at Week 8
Secondary outcomes (4)
Disease control rate
Disease control rate is defined as the proportion of patients with complete response or partial response or stable disease for at least 16 weeks
Measured: Disease evaluation at Week 8
Progression Free Survival
Measured: 1 year
Overall Survival
Measured: 1 year
Safety Profile
Patients will be evaluated for Adverse Events (related or unrelated to the treatment) on Day 1 of each cycle (cycle repeated every 2 weeks) up to 12 weeks from the date of first dose administration
Measured: Every two weeks up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2014 (estimated)
- Study startFeb 2011
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hellenic Oncology Research Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lambros Vamvakas, MD, Principal investigator, University Hospital of HerklionAthanasios Karambeazis, MD, Principal investigator, Medical Oncology Unit NIMTS (Veterans Hospital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02175381
- Sponsor's protocol ID
- CT/10.04
- Status last verified
- May 2015
- First submitted
- 21 Jun 2014
- Last updated
- 15 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Trial of the Carboplatin/Gemcitabine Combination as First Line Treatment for Elderly Patients With Stage IV NSCLC.
- ClinicalTrials.gov ID
- NCT02175381
- Acronym / sponsor ID
- CT/10.04
- Conditions
- NSCLC
- Keywords
- Metastatic NSCLC, Elderly, 1st Line, Platinum-based treatment
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Hellenic Oncology Research GroupUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 26 Jun 2014 (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.
The investigators propose to study the safety and efficacy of the combination of Carboplatin plus Gemcitabine in a Phase I/II trial of elderly subjects with non-small cell lung cancer.
Detailed description
About 50% of newly diagnosed cases of NSCLC concern patients older than 65 years, while 30-40% of cases are diagnosed in patients older than 70 years. Furthermore, recent data suggest that during the last decade, the incidence and mortality of NSCLC has decreased in younger patients, while it has increased among older patients. Based on these observations, it becomes clear that NSCLC represents a significant health problem in elderly patients. However, elderly patients are frequently underrepresented in clinical trials evaluating new treatments in NSCLC. Indeed, more than 75% of patients older than 65 years with metastatic NSCLC never receive any kind of chemotherapy in the daily clinical practice.
In elderly patients there is lack of prospective data regarding the role of platinum-based doublets. It is not clear whether elderly patients gain any survival benefit or not from platinum-based doublets and whether these chemotherapeutic regimens result in a significant increase in toxicity.
There is a clear need to prospectively evaluate the tolerability and efficacy of platinum-based doublets as first-line chemotherapy for older NSCLC patients.
On this basis it would be very interesting to initiate a phase I/II study with gemcitabine/carboplatin combination as first line treatment in older NSCLC patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carbo/GEM | Experimental | Drug: Carboplatin, Drug: Gemcitabine |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (14 listed)
- Age ≥70 years old
- Cytologically or histologically documented NSCLC
- Measurable disease according to Response Evaluation Criteria in Solid Tumors (at least one measurable lesion)
- World Health Organisation (WHO) performance status 0-2
- Non-frail patients according to Comprehensive Geriatric Assessment
Key exclusion criteria (6 listed)
- Hemoptysis
- Central nervous system metastases
- Clinically significant cardiovascular disease
- Medically uncontrolled hypertension
- Other co-existing malignancies or malignancies diagnosed within the last 5 years (with the exception of basal cell carcinoma or cervical cancer in situ)
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 |
|---|---|---|
| CarboplatinCarboplatin: 2.5 AUC i.v on day 1. Cycle repeated ever 2 weeks | Drug | Carbo/GEM |
| GemcitabineGemcitabine: 1100 mg/m2, iv on day 1. Cycle repeated every 2 weeks | Drug | Carbo/GEM |
Primary outcome
Overall Response Rate
Time frame: Disease evaluation at Week 8
4 secondary outcomes
Disease control rate
Time frame: Disease evaluation at Week 8
Progression Free Survival
Time frame: 1 year
Overall Survival
Time frame: 1 year
Safety Profile
Time frame: Every two weeks up to 12 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 15 May 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.
Lambros Vamvakas, MD principal investigator
University Hospital of Herklion
Athanasios Karambeazis, MD principal investigator
Medical Oncology Unit NIMTS (Veterans Hospital)
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Carboplatin and Gemcitabine in people with NSCLC, run by Hellenic Oncology Research Group at 5 sites in Greece.
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 14 inclusion and 6 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 15 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Overall Response Rate (time frame: Disease evaluation at Week 8). 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 15 May 2015.