Non Small Cell Lung CancerPhase 2NCT00401492
MILES-02: Study of Chemotherapy Treatment and Toxicity in Elderly Patients With Advanced Non Small Cell Lung Cancer
A Phase 2 study testing gemcitabine prolonged continuous infusion, cisplatin and vinorelbine in people with Non Small Cell Lung Cancer, run by National Cancer Institute, Naples.
Trial summary
The main purpose of this study is to describe activity and toxicity of single-agent gemcitabine given as prolonged infusion, and of two 2-drug combinations containing cisplatin (cisplatin + vinorelbine, and cisplatin + gemcitabine) in the treatment of elderly patients with advanced non small cell lung cancer Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- gemcitabine prolonged continuous infusion, cisplatin and vinorelbine
- Type of treatment
- Injection or infusion
- How many people
- 159 participants
- Where
- No sites listed yet
- Study dates
- Jun 2002to Apr 2007
- Phase
- Phase 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
- Histologic or cytologic diagnosis of NSCLC
- Stage IV or IIIB with pleural effusion or metastatic supraclavicular lymphoadenopathy
- Age > o = 70 years.
- Written informed consent.
Who cannot join
- Performance status (ECOG) ³2
- Previous chemotherapy.
- Symptomatic brain metastases requiring synchronous radiotherapy
- Previous radiotherapy (completed less than 4 weeks before enrollment)
- Previous or synchronous malignant disease (except adequately treated non melanomatous skin cancer or carcinoma in situ of the cervix) if diagnosed in the last five years before enrollment.
- Neutrophils < 2.000/mm³ or platelets < 100.000/mm³ or hemoglobin < 10 g/dl.
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- Serum creatinine > 1.5 times the UNL.
- GOT and/or GPT >1.25 times the UNL or serum total bilirubin >1.25 times the UNL without hepatic metastases.
- GOT and/or GPT >2.5 times the UNL or serum total bilirubin >1.5 times the UNL with hepatic metastases.
- Other concomitant diseases contraindicating the study treatments.
- Refusal of written informed consent.
- Follow-up impossible.
About this study
Official title: Phase II Study of Chemotherapy With Gemcitabine in Prolonged Infusion or With Schedules With Cisplatin in Non-small Cell Lung Cancer Elderly Patients
The main purpose of this study is to describe activity and toxicity of single-agent gemcitabine given as prolonged infusion, and of two 2-drug combinations containing cisplatin (cisplatin + vinorelbine, and cisplatin + gemcitabine) in the treatment of elderly patients with advanced non small cell lung cancer
Read the detailed description
The study design includes three parallel phase II studies, all with the same rules for patient selection and outcome assessment. In the two studies of cisplatin-based doublets, a dose-finding phase is planned, with subsequent cohorts of 6 patients treated with increasing doses of cisplatin (50-60-70 mg/m²). Following this phase, patients will be assigned to the three studies through a randomization procedure, to reduce selection biases.
Arm A: gemcitabine:
Gemcitabine 1200 mg/m2 intravenously in 2 hours (10 mg/m²/minute) on days 1 \& 8 of each cycle, every 21 days, for a maximum of 6 cycles.
Arm B: cisplatin + vinorelbine:
Vinorelbine 25 mg/m² on days 1 \& 8, followed by Cisplatin (50 or 60 or 70 mg/m²) on day 1 of each cycle, every 21 days, for a maximum of 6 cycles.
Arm C: cisplatin + gemcitabine:
Gemcitabine 1000 mg/m2,, on days 1 \& 8, followed by Cisplatin (50 or 60 or 70 mg/m²) on day 1 of each cycle, every 21 days, for a maximum of 6 cycles.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- gemcitabine prolonged continuous infusion, cisplatin, vinorelbine
- Keywords
- elderly, chemotherapy, quality of life, ADL, toxicity
- 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.
gemcitabine prolonged continuous infusionDrug
cisplatinDrug
vinorelbineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Activity and toxicity of monochemotherapy with gemcitabine as prolonged infusion
Toxicity and activity of 2 standard polychemotherapy cisplatin based treatments (cisplatin and vinorelbine , and cisplatin and gemcitabine
Secondary outcomes (4)
patient quality of life
the prognostic significance of the ADL and IADL scales for time to progression and survival
exploratory predictive clinical variables for chemotherapy related toxicity
exploratory predictive clinical variables for response to chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2006 (estimated)
- Study startJun 2002
- Primary completionDec 2006
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Non Small Cell Lung CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Naples
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cesare Gridelli, M.D., Principal investigator, San Giuseppe Moscati HospitalFrancesco Perrone, M.D., Principal investigator, National Cancer Institute, Naples Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00401492
- Sponsor's protocol ID
- MILES-02
- Status last verified
- Jul 2012
- First submitted
- 17 Nov 2006
- Last updated
- 13 Jul 2012
- Results posted
- No
Publications
Gridelli C, Maione P, Illiano A, Piantedosi FV, Favaretto A, Bearz A, Robbiati SF, Filipazzi V, Lorusso V, Carrozza F, Iaffaioli RV, Manzione L, Gallo C, Morabito A, Perrone F. Cisplatin plus gemcitabine or vinorelbine for elderly patients with advanced non small-cell lung cancer: the MILES-2P studies. J Clin Oncol. 2007 Oct 10;25(29):4663-9. doi: 10.1200/JCO.2007.12.5708.
PubMed 17925563Gridelli C, De Maio E, Barbera S, Sannicolo M, Piazza E, Piantedosi F, Brancaccio L, Morabito A, Maione P, Renda F, Signoriello G, Perrone F; MILES Investigators. The MILES-2G phase 2 study of single-agent gemcitabine with prolonged constant infusion in advanced non-small cell lung cancer elderly patients. Lung Cancer. 2008 Jul;61(1):67-72. doi: 10.1016/j.lungcan.2007.12.002.
PubMed 18683299
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Chemotherapy With Gemcitabine in Prolonged Infusion or With Schedules With Cisplatin in Non-small Cell Lung Cancer Elderly Patients
- ClinicalTrials.gov ID
- NCT00401492
- Acronym / sponsor ID
- MILES-02
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- elderly, chemotherapy, quality of life, ADL, toxicity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- National Cancer Institute, NaplesUniversity, hospital or other
- Study start
- Jun 2002
- Primary completion
- Dec 2006 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 20 Nov 2006 (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 main purpose of this study is to describe activity and toxicity of single-agent gemcitabine given as prolonged infusion, and of two 2-drug combinations containing cisplatin (cisplatin + vinorelbine, and cisplatin + gemcitabine) in the treatment of elderly patients with advanced non small cell lung cancer
Detailed description
The study design includes three parallel phase II studies, all with the same rules for patient selection and outcome assessment. In the two studies of cisplatin-based doublets, a dose-finding phase is planned, with subsequent cohorts of 6 patients treated with increasing doses of cisplatin (50-60-70 mg/m²). Following this phase, patients will be assigned to the three studies through a randomization procedure, to reduce selection biases.
Arm A: gemcitabine:
Gemcitabine 1200 mg/m2 intravenously in 2 hours (10 mg/m²/minute) on days 1 \& 8 of each cycle, every 21 days, for a maximum of 6 cycles.
Arm B: cisplatin + vinorelbine:
Vinorelbine 25 mg/m² on days 1 \& 8, followed by Cisplatin (50 or 60 or 70 mg/m²) on day 1 of each cycle, every 21 days, for a maximum of 6 cycles.
Arm C: cisplatin + gemcitabine:
Gemcitabine 1000 mg/m2,, on days 1 \& 8, followed by Cisplatin (50 or 60 or 70 mg/m²) on day 1 of each cycle, every 21 days, for a maximum of 6 cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Histologic or cytologic diagnosis of NSCLC
- Stage IV or IIIB with pleural effusion or metastatic supraclavicular lymphoadenopathy
- Age > o = 70 years.
- Written informed consent.
Key exclusion criteria (12 listed)
- Performance status (ECOG) ³2
- Previous chemotherapy.
- Symptomatic brain metastases requiring synchronous radiotherapy
- Previous radiotherapy (completed less than 4 weeks before enrollment)
- Previous or synchronous malignant disease (except adequately treated non melanomatous skin cancer or carcinoma in situ of the cervix) if diagnosed in the last five years before enrollment.
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 |
|---|---|---|
| gemcitabine prolonged continuous infusion | Drug | – |
| cisplatin | Drug | – |
| vinorelbine | Drug | – |
Primary outcome
Activity and toxicity of monochemotherapy with gemcitabine as prolonged infusion
Toxicity and activity of 2 standard polychemotherapy cisplatin based treatments (cisplatin and vinorelbine , and cisplatin and gemcitabine
4 secondary outcomes
patient quality of life
the prognostic significance of the ADL and IADL scales for time to progression and survival
exploratory predictive clinical variables for chemotherapy related toxicity
exploratory predictive clinical variables for response to chemotherapy
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 13 Jul 2012.
- Results publication: PubMed 17925563Gridelli C, Maione P, Illiano A, Piantedosi FV, Favaretto A, Bearz A, Robbiati SF, Filipazzi V, Lorusso V, Carrozza F, Iaffaioli RV, Manzione L, Gallo C, Morabito A, Perrone F. Cisplatin plus gemcitabine or vinorelbine for elderly patients with advanced non small-cell lung cancer: the MILES-2P studies. J Clin Oncol. 2007 Oct 10;25(29):4663-9. doi: 10.1200/JCO.2007.12.5708.
- Results publication: PubMed 18683299Gridelli C, De Maio E, Barbera S, Sannicolo M, Piazza E, Piantedosi F, Brancaccio L, Morabito A, Maione P, Renda F, Signoriello G, Perrone F; MILES Investigators. The MILES-2G phase 2 study of single-agent gemcitabine with prolonged constant infusion in advanced non-small cell lung cancer elderly patients. Lung Cancer. 2008 Jul;61(1):67-72. doi: 10.1016/j.lungcan.2007.12.002.
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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.
Cesare Gridelli, M.D. principal investigator
San Giuseppe Moscati Hospital
Francesco Perrone, M.D. principal investigator
National Cancer Institute, Naples Italy
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing gemcitabine prolonged continuous infusion, cisplatin and vinorelbine in people with Non Small Cell Lung Cancer, run by National Cancer Institute, Naples.
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 4 inclusion and 12 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 13 Jul 2012. 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 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?
Activity and toxicity of monochemotherapy with gemcitabine as prolonged infusion. 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?
On the ClinicalTrials.gov record for NCT00401492, which also lists 2 linked publications.
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 13 Jul 2012; AzTrials last refreshed its copy on 8 Nov 2026.