Non Small Cell Lung CancerPhase 2NCT00614965
Irinotecan Plus Cisplatin vs Pemetrexed Plus Cisplatin as 2nd Line in NSCLC Stage IIIB/IV
A Phase 2 study testing Irinotecan, Cisplatin and Pemetrexed in people with Non Small Cell Lung Cancer, run by Hellenic Oncology Research Group at 2 sites in Greece.
Trial summary
This trial will compare the efficacy of irinotecan/cisplatin and pemetrexed/cisplatin in the second-line treatment of patients with stage IIIB/IV NSCLC Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Irinotecan, Cisplatin and Pemetrexed
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 2 sitesGreece
- Study dates
- Nov 2006to Mar 2010
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed NSCLC
- Age 18 -75 years
- Performance status (WHO) <2
- Patients progressing after first-line docetaxel/gemcitabine treatment
- Adequate bone marrow (absolute neutrophil count >1000/mm3, platelet count >100000/mm3, hemoglobin > 9 gr/ mm3)
- Adequate liver (bilirubin <1.5 times upper limit of normal), renal (Creatinine clearance > 50mg/min) and cardiac (LVEF >50%) function
- Presence of measurable disease (according to RESIST criteria)
- Informed consent
Who cannot join
- Psychiatric illness or social situation that would preclude study compliance'
- Other concurrent uncontrolled illness.
- Other invasive malignancy within the past 5 years except nonmelanoma skin cancer
Trial locations and contacts
2 sites in 1 country.
Greece2 sites
Air Forces Military Hospital, Dep of Medical Oncology
Athens
IASO" General Hospital of Athens, 1st Dep of Medical Oncology
Athens
About this study
Official title: A Multicenter Randomized Phase II Study of the Combination of Irinotecan/Cisplatin Versus Pemetrexed/Cisplatin as Second-line Treatment of Patients With Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC)
This trial will compare the efficacy of irinotecan/cisplatin and pemetrexed/cisplatin in the second-line treatment of patients with stage IIIB/IV NSCLC
Read the detailed description
Non-platinum-based doublets including the newer drugs can be used instead of platinum-based regimens in the first line treatment of patients with advanced NSCLC. Docetaxel or pemetrexed have been proven effective as second-line treatment of patients with NSCLC. In a study conducted by our group the combination of irinotecan/cisplatin demonstrated higher response rates over cisplatin monotherapy in patients progressing after first-line docetaxel/gemcitabine. Moreover, pemetrexed has been combined with the platinums (ie, cisplatin, carboplatin, and oxaliplatin) in NSCLC to yield clinical activity similar to that of other platinum-based doublets. The efficacy of different platinum-based combinations in patients pretreated with non-platinum based first-line chemotherapy is not known.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Irinotecan, Cisplatin, Pemetrexed
- Keywords
- Cancer, NSCLC, second-line chemotherapy, irinotecan, pemetrexed
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IrinotecanDrug
Also called CPT-11
Irinotecan at the dose of 110 mg/m2 IV on day 1 every 3 weeks for 6 consecutive cycles
CisplatinDrug
Also called CDDP
Cisplatin at the dose of 80 mg/m2 IV on day 1 every 3 weeks for 6 consecutive cycles
PemetrexedDrug
Also called Alimta
Pemetrexed at the dose of 500mg/m2 IV every 3 weeks for 6 consecutive cycles
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | IC Receives: Drug: Irinotecan; Drug: Cisplatin |
| 2 | Experimental | PC Receives: Drug: Cisplatin; Drug: Pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate
Measured: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)
Secondary outcomes (4)
Time to Tumor Progression
Measured: 1-year
Overall Survival
Measured: 1-year
Toxicity profile between the two treatment arms
Measured: Toxicity assessment on each chemotherapy cycles
Quality of life assessment
Measured: Assessment every two cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2008 (estimated)
- Study startNov 2006
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hellenic Oncology Research Group
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital of Crete
- Investigators
- Sofia Aggelaki, MD, Principal investigator, University Hospital of Crete, Dep of Medical Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00614965
- Sponsor's protocol ID
- CT/06.16
- Status last verified
- May 2011
- First submitted
- 1 Feb 2008
- Last updated
- 23 May 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Kentepozidis N, Economopoulou P, Christofyllakis C, Chelis L, Polyzos A, Vardakis N, Koinis F, Vamvakas L, Katsaounis P, Kalbakis K, Nikolaou C, Georgoulias V, Kotsakis A. Salvage treatment with irinotecan/cisplatin versus pemetrexed/cisplatin in patients with non-small cell lung cancer pre-treated with a non-platinum-based regimen in the first-line setting: a randomized phase II study of the Hellenic Oncology Research Group (HORG). Clin Transl Oncol. 2017 Mar;19(3):317-325. doi: 10.1007/s12094-016-1532-y. Epub 2016 Aug 4.
PubMed 27492015
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Phase II Study of the Combination of Irinotecan/Cisplatin Versus Pemetrexed/Cisplatin as Second-line Treatment of Patients With Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT00614965
- Acronym / sponsor ID
- CT/06.16
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- Cancer, NSCLC, second-line chemotherapy, irinotecan, pemetrexed
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Hellenic Oncology Research GroupUniversity, hospital or other
- Collaborators
- University Hospital of Crete
- Study start
- Nov 2006
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 14 Feb 2008 (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 trial will compare the efficacy of irinotecan/cisplatin and pemetrexed/cisplatin in the second-line treatment of patients with stage IIIB/IV NSCLC
Detailed description
Non-platinum-based doublets including the newer drugs can be used instead of platinum-based regimens in the first line treatment of patients with advanced NSCLC. Docetaxel or pemetrexed have been proven effective as second-line treatment of patients with NSCLC. In a study conducted by our group the combination of irinotecan/cisplatin demonstrated higher response rates over cisplatin monotherapy in patients progressing after first-line docetaxel/gemcitabine. Moreover, pemetrexed has been combined with the platinums (ie, cisplatin, carboplatin, and oxaliplatin) in NSCLC to yield clinical activity similar to that of other platinum-based doublets. The efficacy of different platinum-based combinations in patients pretreated with non-platinum based first-line chemotherapy is not known.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Irinotecan, Drug: CisplatinIC |
| 2 | Experimental | Drug: Cisplatin, Drug: PemetrexedPC |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically or cytologically confirmed NSCLC
- Age 18 -75 years
- Performance status (WHO) <2
- Patients progressing after first-line docetaxel/gemcitabine treatment
- Adequate bone marrow (absolute neutrophil count >1000/mm3, platelet count >100000/mm3, hemoglobin > 9 gr/ mm3)
Key exclusion criteria (3 listed)
- Psychiatric illness or social situation that would preclude study compliance'
- Other concurrent uncontrolled illness.
- Other invasive malignancy within the past 5 years except nonmelanoma skin cancer
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 |
|---|---|---|
| IrinotecanAlso: CPT-11Irinotecan at the dose of 110 mg/m2 IV on day 1 every 3 weeks for 6 consecutive cycles | Drug | 1 |
| CisplatinAlso: CDDPCisplatin at the dose of 80 mg/m2 IV on day 1 every 3 weeks for 6 consecutive cycles | Drug | 1, 2 |
| PemetrexedAlso: AlimtaPemetrexed at the dose of 500mg/m2 IV every 3 weeks for 6 consecutive cycles | Drug | 2 |
Primary outcome
Overall Response Rate
Time frame: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)
4 secondary outcomes
Time to Tumor Progression
Time frame: 1-year
Overall Survival
Time frame: 1-year
Toxicity profile between the two treatment arms
Time frame: Toxicity assessment on each chemotherapy cycles
Quality of life assessment
Time frame: Assessment every two cycles
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 23 May 2011.
- Derived from this study: PubMed 27492015Kentepozidis N, Economopoulou P, Christofyllakis C, Chelis L, Polyzos A, Vardakis N, Koinis F, Vamvakas L, Katsaounis P, Kalbakis K, Nikolaou C, Georgoulias V, Kotsakis A. Salvage treatment with irinotecan/cisplatin versus pemetrexed/cisplatin in patients with non-small cell lung cancer pre-treated with a non-platinum-based regimen in the first-line setting: a randomized phase II study of the Hellenic Oncology Research Group (HORG). Clin Transl Oncol. 2017 Mar;19(3):317-325. doi: 10.1007/s12094-016-1532-y. Epub 2016 Aug 4.
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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.
Sofia Aggelaki, MD principal investigator
University Hospital of Crete, Dep of Medical Oncology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Irinotecan, Cisplatin and Pemetrexed in people with Non Small Cell Lung Cancer, run by Hellenic Oncology Research Group at 2 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 8 inclusion and 3 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 23 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 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?
Overall Response Rate (time frame: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)). 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 NCT00614965, which also lists 1 linked publication.
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 23 May 2011.