Non Small Cell Lung CancerPhase 2NCT00350792
Pemetrexed/Carboplatin Non-Small Cell Lung Cancer (NSCLC) Elderly Patients
A Phase 2 study testing pemetrexed and carboplatin in people with Non Small Cell Lung Cancer, run by Eli Lilly and Company at 7 sites in France.
Trial summary
A phase II study to evaluate the efficacy and safety profile of the combination of Pemetrexed and Carboplatin in 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?
- pemetrexed and carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 7 sitesFrance
- Study dates
- Aug 2006to Nov 2009
- Phase
- Phase 2
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Pathologically confirmed Non Small Cell Lung Cancer Stage IIIb (not amenable to radiotherapy treatment) or Stage IV
- No previous chemotherapy for lung cancer
- Men and women > or = 70 years
- At least one uni-dimensionally measurable lesion (Response Evaluation Criteria In Solid Tumors [RECIST]criteria)
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1
Who cannot join
- Treatment within the last 30 days with a drug that has not received regulatory approval
- Serious systemic disorders
- Inability to discontinue administration of aspirin or anti-inflammatory non steroid
- Concurrent administration of any other antitumor therapy
- Brain metastasis
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Bobigny, 93009
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Brest, 29609
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Caen, 14076
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Le Mans, 72000
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Lille, 59000
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Nantes, 44202
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Vandœuvre-lès-Nancy, 54511
About this study
Official title: A Phase II Trial Pemetrexed Carboplatin as First Line Chemotherapy for Advanced Non-Small Cell Lung Cancer (NSCLC) in Elderly Patients
A phase II study to evaluate the efficacy and safety profile of the combination of Pemetrexed and Carboplatin in elderly patients with advanced non-small cell lung cancer
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- pemetrexed, carboplatin
- 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.
pemetrexedDrug
Also called LY231514, Alimta
500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 6 cycles
carboplatinDrug
Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
| Study group | Role | What they receive |
|---|---|---|
| Pemetrexed + Carboplatin | Experimental | Pemetrexed: 500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 6 cycles.
Carboplatin: Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles. Receives: Drug: pemetrexed; Drug: carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With a Complete or Partial Tumor Response (Overall Tumor Response)
Tumor response is defined as the percentage of patients with either a complete response or a partial response. Response was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions and Partial Response=30% decrease in sum of longest diameter of target lesions.
Measured: baseline to measured objective tumor response (up to six 21-day cycles)
Secondary outcomes (3)
Time to Treatment Failure
Defined as the time from study enrollment to the first observation of disease progression, death as a result of any cause, or early discontinuation of treatment. Time to treatment failure was censored at the date of the last follow-up visit for patients who did not discontinue early, who were still alive, and who have not progressed.
Measured: baseline to stopping treatment (up to six 21-day cycles)
Overall Survival
Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.
Measured: baseline to date of death from any cause (up to 14.5 months)
Estimated Probability of One Year Progression-free Survival
Progression free survival (PFS) is the duration from enrollment until first disease progression or death. For patients not known to have died as of the data cut-off date and who do not have progressive disease, PFS is censored at the last radiological assessment date.
Measured: baseline to measured progressive disease or death, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2006 (estimated)
- Study startAug 2006
- Primary completionNov 2008
- Study completionNov 2009
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 Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00350792
- Sponsor's protocol ID
- 9941
- Other IDs
- H3E-FP-S099
- Status last verified
- Oct 2010
- First submitted
- 10 Jul 2006
- Last updated
- 13 Oct 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial Pemetrexed Carboplatin as First Line Chemotherapy for Advanced Non-Small Cell Lung Cancer (NSCLC) in Elderly Patients
- ClinicalTrials.gov ID
- NCT00350792
- Acronym / sponsor ID
- 9941
- Conditions
- Non Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 11 Jul 2006 (estimated)
- Results
- Posted 9 Dec 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A phase II study to evaluate the efficacy and safety profile of the combination of Pemetrexed and Carboplatin in elderly patients with advanced non-small cell lung cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pemetrexed + Carboplatin | Experimental | Drug: pemetrexed, Drug: carboplatinPemetrexed: 500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 6 cycles. Carboplatin: Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Pathologically confirmed Non Small Cell Lung Cancer Stage IIIb (not amenable to radiotherapy treatment) or Stage IV
- No previous chemotherapy for lung cancer
- Men and women > or = 70 years
- At least one uni-dimensionally measurable lesion (Response Evaluation Criteria In Solid Tumors [RECIST]criteria)
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1
Key exclusion criteria (5 listed)
- Treatment within the last 30 days with a drug that has not received regulatory approval
- Serious systemic disorders
- Inability to discontinue administration of aspirin or anti-inflammatory non steroid
- Concurrent administration of any other antitumor therapy
- Brain metastasis
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 |
|---|---|---|
| pemetrexedAlso: LY231514, Alimta500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 6 cycles | Drug | Pemetrexed + Carboplatin |
| carboplatinArea Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles | Drug | Pemetrexed + Carboplatin |
Primary outcome
Percentage of Participants With a Complete or Partial Tumor Response (Overall Tumor Response)
Time frame: baseline to measured objective tumor response (up to six 21-day cycles)
Tumor response is defined as the percentage of patients with either a complete response or a partial response. Response was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions and Partial Response=30% decrease in sum of longest diameter of target lesions.
3 secondary outcomes
Time to Treatment Failure
Time frame: baseline to stopping treatment (up to six 21-day cycles)
Overall Survival
Time frame: baseline to date of death from any cause (up to 14.5 months)
Estimated Probability of One Year Progression-free Survival
Time frame: baseline to measured progressive disease or death, 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2010.
- 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.
1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
7 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 pemetrexed and carboplatin in people with Non Small Cell Lung Cancer, run by Eli Lilly and Company at 7 sites in France.
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 5 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 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. 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?
Yes. Results are posted in the registry (first posted 9 Dec 2009). 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?
Percentage of Participants With a Complete or Partial Tumor Response (Overall Tumor Response) (time frame: baseline to measured objective tumor response (up to six 21-day cycles)). 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 13 Oct 2010.