Non-Small Cell Lung CancerPhase 1/2NCT00529100
Concurrent Pemetrexed, Cisplatin and Radiation Therapy in Patients With Stage IIIA/B Non Small Cell Lung Cancer
A Phase 1/2 study testing Pemetrexed Phase 1, Cisplatin Phase 1 and Radiation Therapy in people with Non-Small Cell Lung Cancer, run by Eli Lilly and Company at 4 sites in Canada.
Trial summary
Measure the 1 year survival of non small cell lung cancer (NSCLC) patients who are being treated with pemetrexed in combination with cisplatin and radiation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Pemetrexed Phase 1, Cisplatin Phase 1 and Radiation Therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 4 sitesCanada
- Study dates
- Dec 2005to Sep 2012
- Phase
- Phase 1/2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Some of the requirements to be in this study are:
- Patient must be at least 18 years old.
- Patient must have been diagnosed with non-small cell lung cancer.
- Patient must be able to visit the doctor's office once a week.
- Patient must have adequate blood, liver, lungs and kidney function within the requirements of this study.
- Female patients of child-bearing potential must test negative for pregnancy at the time of enrollment based on a serum pregnancy test. Male and female patients must agree to use a reliable method of birth control during and for 3 months following the last dose of study drug.
Who cannot join
- Patients cannot participate in this study for any of the following reasons:
- Patient has previously had chemotherapy.
- Patient has previously had thoracic radiation therapy.
- Patient has received treatment within the last 30 days with a drug that has not received approval by Health Canada for any indication at the time of study entry.
- Female patient is pregnant or breast-feeding.
- Patient is unsuitable to participate in the study in the opinion of the investigator.
- Patient is unable or unwilling to take folic acid, vitamin B12 supplementation, or dexamethasone.
Trial locations and contacts
4 sites in 1 country.
Canada4 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.
Edmonton, Alberta, T6G 1Z2
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.
Hamilton, Ontario, L8V 5C2
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.
Ottawa, Ontario, K1H 8L6
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.
Toronto, Ontario, M5G 2M9
About this study
Official title: A Phase I/II Study of Concurrent Pemetrexed/Cisplatin/Radiation in Stage IIIA/B Non-Small Cell Lung Cancer
Measure the 1 year survival of non small cell lung cancer (NSCLC) patients who are being treated with pemetrexed in combination with cisplatin and radiation.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Pemetrexed Phase 1, Cisplatin Phase 1, Radiation Therapy, Pemetrexed Phase 2, Cisplatin Phase 2
- 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.
Pemetrexed Phase 1Drug
Also called LY231514, Alimta
300 mg/m^2 IV, Days 1 and 22; intermediate dose escalation level of 400 mg/m^2 IV; then 500 mg/m^2 IV, repeated every 21 days (q 21 days) x 2 cycles
Cisplatin Phase 1Drug
Cohorts 1-3: 25 mg/m^2 IV, Days 1-3 and 22-24 then 75 mg/m^2 IV, q21 days x 2 cycles
Cohort 4 carried into Phase 2: 20 mg/m^2 IV, Days 1-5 and 22-26 then 75 mg/m^2 IV, q21 days x 2 cycles.
Radiation TherapyProcedure or surgery
Phases 1 and 2: 61-65 Gy in 33-35 fractions
Pemetrexed Phase 2Drug
Also called LY231514, Alimta
Concurrent phase pemetrexed IV bolus as determined by Phase 1 trial to be 500 mg/m^2 IV on Days 1 and 22.
Cisplatin Phase 2Drug
Phase 2 (Cohort 4 carried over from Phase 1): 20 mg/m^2 IV, Days 1-5 and 22-26 then 75 mg/m^2 IV, q21 days x 2 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Pemetrexed/Cisplatin/Radiation Phase 1 | Experimental | Treatment included: radiation as 61-65 Gray (Gy) in 33-35 fractions if 2-phase treatment and 62-66 Gy in 31-33 fractions if 1-phase treatment; concurrent pemetrexed intravenous (IV) bolus with doses escalating from 300 milligrams per square meter (mg/m^2) IV through 500 mg/m^2 IV on Days 1 and 22; concurrent cisplatin 25 mg/m^2 IV on Days 1-3 and 22-24 for Cohorts 1-3 and cisplatin 20 mg/m^2 IV on Days 1-5 and 22-26 for Cohort 4. Participants then received 2 additional consolidation cycles repeated every 3 weeks (q3 weeks) of pemetrexed 500 mg/m^2 IV and cisplatin 75 mg/m^2 IV. Receives: Drug: Pemetrexed Phase 1; Drug: Cisplatin Phase 1; Procedure: Radiation Therapy |
| Pemetrexed/Cisplatin/Radiation Phase 2 | Experimental | Treatment included: radiation, 61-65 Gy in 33-35 fractions if 2-phase treatment and 62-66 Gy in 31-33 fractions if 1-phase treatment; concurrent phase pemetrexed IV bolus as determined by Phase 1 trial to be 500 mg/m^2 IV on Days 1 and 22 ; concurrent cisplatin 20 mg/m^2 IV as determined by Phase 1 trial with cycles commencing on Days 1 and 22; 2 additional consolidation cycles (q3 weeks) of pemetrexed 500 mg/m^2 IV and cisplatin 75 mg/m^2 IV. Receives: Procedure: Radiation Therapy; Drug: Pemetrexed Phase 2; Drug: Cisplatin Phase 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Maximum Tolerated Dose (MTD) of Pemetrexed in Combination With Cisplatin and Radiation Therapy
Recommended Phase 2 MTD was highest dose at which no more than 1 of 6 participants experienced dose level toxicity (DLT). DLT=(1) Grade 3/4 dysphagia/esophagitis, leukopenia, thrombocytopenia, febrile neutropenia, fatigue/malaise, pneumonitis, dermatitis, persistent elevation of bilirubin/alkaline phosphatase/aspartate aminotransferase only if resulting in delay of radiotherapy >1 week, delay of pemetrexed/cisplatin Cycle 2 >2 weeks, or delay of pemetrexed/cisplatin Cycle 3 past 5 weeks after radiotherapy; (2) other Grade 3 or 4 toxicity possibly related to concurrent treatment administration.
Measured: Baseline to measured progressive disease (PD; up to 1 year)
Phase 2: Percentage of Participants With Overall Survival (OS) at 1 Year
OS was defined as the time from date of enrollment to death due to any cause.
Measured: Baseline to date of death from any cause (up to 1 year)
Secondary outcomes (7)
Phase 1: Number of Participants With Adverse Events (AE; Toxicity)
A listing of AEs is located in the Reported Adverse Event module.
Measured: Baseline to measured PD (up to 1 year)
Phase 2: Percentage of Participants With Overall Survival (OS) at 2 Years and 3 Years
OS was defined as the time from date of enrollment to death due to any cause.
Measured: Baseline and 2 years and 3 years
Phase 2: Time to Progressive Disease (PD)
Time to PD was defined as the time from study enrollment to the first date of objective disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.0) as at least a 20% increase in the sum of the longest diameter (LD) of target lesions as references the smallest sum LD recorded since treatment started or the appearance of 1 or more new lesions. Time to PD was censored at the date of death if death was due to other cause. For participants not known to have died as of the data cut-off date and who did not have PD, time to PD was censored at the last progression-free disease assessment. For participants who received subsequent cancer therapy (after discontinuation from the study therapy) before PD, time to PD was censored at the date of subsequent cancer therapy initiation.
Measured: Baseline to measured PD (up to 3 years)
Phase 2: Percentage of Participants With Progression Free Survival (PFS)
The percentage of participants not known to have died as of the data cut-off date or last contact and who did not have PD.
Measured: Baseline and 1 year and 2 years and 3 years
Progression Free Survival (PFS)
PFS was defined as the period from study entry until PD, death, or date of last contact. For participants not known to have died as of the data cut-off date and who did not have PD, the PFS date was censored at the last contact date (contacts considered in the determination of last progression free disease assessment).
Measured: Baseline to measured PD (up to 36 months)
Phase 2: Percentage of Participants With Objective Tumor Response (Response Rate)
Response using Response Evaluation Criteria In Solid Tumors (RECIST 1.0). Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD)=20% increase in sum of longest diameter of target lesions; Stable Disease (SD)=small changes that do not meet above criteria. Objective response rate (%)=number of objective responders divided by the number of participants with measurable disease * 100, where objective responders are those participants who have met criteria either for CR or PR.
Measured: Baseline to measured PD (up to 3 years)
Phase 2: Site of Progressive Disease (PD)
Summarized participants with local (progression within the sites of initial disease)/regional (disease progression adjacent to but not within the site of initial disease at the start of treatment), distant (disease progression that is blood borne to other parts of the body, including outside the chest or involving the contralateral lung), and local + distant sites of disease. Objective PD is defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.0) as at least a 20% increase in the sum of the longest diameter (LD) of target lesions as references the smallest sum LD recorded since treatment started or the appearance of 1 or more new lesions.
Measured: Baseline to measured PD (up to 3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2007 (estimated)
- Study startDec 2005
- Primary completionAug 2010
- Study completionSep 2012
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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 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
- NCT00529100
- Sponsor's protocol ID
- 10259
- Other IDs
- H3E-CA-JMHU
- Status last verified
- Jul 2013
- First submitted
- 12 Sep 2007
- Last updated
- 9 Jul 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of Concurrent Pemetrexed/Cisplatin/Radiation in Stage IIIA/B Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00529100
- Acronym / sponsor ID
- 10259
- Conditions
- Non-Small Cell Lung Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- Aug 2010 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 14 Sep 2007 (estimated)
- Results
- Posted 28 Sep 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Measure the 1 year survival of non small cell lung cancer (NSCLC) patients who are being treated with pemetrexed in combination with cisplatin and radiation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pemetrexed/Cisplatin/Radiation Phase 1 | Experimental | Drug: Pemetrexed Phase 1, Drug: Cisplatin Phase 1, Procedure: Radiation TherapyTreatment included: radiation as 61-65 Gray (Gy) in 33-35 fractions if 2-phase treatment and 62-66 Gy in 31-33 fractions if 1-phase treatment; concurrent pemetrexed intravenous (IV) bolus with doses escalating from 300 milligrams per square meter (mg/m^2) IV through 500 mg/m^2 IV on Days 1 and 22; concurrent cisplatin 25 mg/m^2 IV on Days 1-3 and 22-24 for Cohorts 1-3 and cisplatin 20 mg/m^2 IV on Days 1-5 and 22-26 for Cohort 4. Participants then received 2 additional consolidation cycles repeated every 3 weeks (q3 weeks) of pemetrexed 500 mg/m^2 IV and cisplatin 75 mg/m^2 IV. |
| Pemetrexed/Cisplatin/Radiation Phase 2 | Experimental | Procedure: Radiation Therapy, Drug: Pemetrexed Phase 2, Drug: Cisplatin Phase 2Treatment included: radiation, 61-65 Gy in 33-35 fractions if 2-phase treatment and 62-66 Gy in 31-33 fractions if 1-phase treatment; concurrent phase pemetrexed IV bolus as determined by Phase 1 trial to be 500 mg/m^2 IV on Days 1 and 22 ; concurrent cisplatin 20 mg/m^2 IV as determined by Phase 1 trial with cycles commencing on Days 1 and 22; 2 additional consolidation cycles (q3 weeks) of pemetrexed 500 mg/m^2 IV and cisplatin 75 mg/m^2 IV. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient must be at least 18 years old.
- Patient must have been diagnosed with non-small cell lung cancer.
- Patient must be able to visit the doctor's office once a week.
- Patient must have adequate blood, liver, lungs and kidney function within the requirements of this study.
- Female patients of child-bearing potential must test negative for pregnancy at the time of enrollment based on a serum pregnancy test. Male and female patients must agree to use a reliable method of birth control during and for 3 months following the last dose of study drug.
Key exclusion criteria (7 listed)
- Patient has previously had chemotherapy.
- Patient has previously had thoracic radiation therapy.
- Patient has received treatment within the last 30 days with a drug that has not received approval by Health Canada for any indication at the time of study entry.
- Female patient is pregnant or breast-feeding.
- Patient is unsuitable to participate in the study in the opinion of the investigator.
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 |
|---|---|---|
| Pemetrexed Phase 1Also: LY231514, Alimta300 mg/m^2 IV, Days 1 and 22; intermediate dose escalation level of 400 mg/m^2 IV; then 500 mg/m^2 IV, repeated every 21 days (q 21 days) x 2 cycles | Drug | Pemetrexed/Cisplatin/Radiation Phase 1 |
| Cisplatin Phase 1Cohorts 1-3: 25 mg/m^2 IV, Days 1-3 and 22-24 then 75 mg/m^2 IV, q21 days x 2 cycles Cohort 4 carried into Phase 2: 20 mg/m^2 IV, Days 1-5 and 22-26 then 75 mg/m^2 IV, q21 days x 2 cycles. | Drug | Pemetrexed/Cisplatin/Radiation Phase 1 |
| Radiation TherapyPhases 1 and 2: 61-65 Gy in 33-35 fractions | Procedure or surgery | Pemetrexed/Cisplatin/Radiation Phase 1, Pemetrexed/Cisplatin/Radiation Phase 2 |
| Pemetrexed Phase 2Also: LY231514, AlimtaConcurrent phase pemetrexed IV bolus as determined by Phase 1 trial to be 500 mg/m^2 IV on Days 1 and 22. | Drug | Pemetrexed/Cisplatin/Radiation Phase 2 |
| Cisplatin Phase 2Phase 2 (Cohort 4 carried over from Phase 1): 20 mg/m^2 IV, Days 1-5 and 22-26 then 75 mg/m^2 IV, q21 days x 2 cycles. | Drug | Pemetrexed/Cisplatin/Radiation Phase 2 |
Primary outcome
Phase 1: Maximum Tolerated Dose (MTD) of Pemetrexed in Combination With Cisplatin and Radiation Therapy
Time frame: Baseline to measured progressive disease (PD; up to 1 year)
Recommended Phase 2 MTD was highest dose at which no more than 1 of 6 participants experienced dose level toxicity (DLT). DLT=(1) Grade 3/4 dysphagia/esophagitis, leukopenia, thrombocytopenia, febrile neutropenia, fatigue/malaise, pneumonitis, dermatitis, persistent elevation of bilirubin/alkaline phosphatase/aspartate aminotransferase only if resulting in delay of radiotherapy >1 week, delay of pemetrexed/cisplatin Cycle 2 >2 weeks, or delay of pemetrexed/cisplatin Cycle 3 past 5 weeks after radiotherapy; (2) other Grade 3 or 4 toxicity possibly related to concurrent treatment administration.
Phase 2: Percentage of Participants With Overall Survival (OS) at 1 Year
Time frame: Baseline to date of death from any cause (up to 1 year)
OS was defined as the time from date of enrollment to death due to any cause.
7 secondary outcomes
Phase 1: Number of Participants With Adverse Events (AE; Toxicity)
Time frame: Baseline to measured PD (up to 1 year)
Phase 2: Percentage of Participants With Overall Survival (OS) at 2 Years and 3 Years
Time frame: Baseline and 2 years and 3 years
Phase 2: Time to Progressive Disease (PD)
Time frame: Baseline to measured PD (up to 3 years)
Phase 2: Percentage of Participants With Progression Free Survival (PFS)
Time frame: Baseline and 1 year and 2 years and 3 years
Progression Free Survival (PFS)
Time frame: Baseline to measured PD (up to 36 months)
Phase 2: Percentage of Participants With Objective Tumor Response (Response Rate)
Time frame: Baseline to measured PD (up to 3 years)
Phase 2: Site of Progressive Disease (PD)
Time frame: Baseline to measured PD (up to 3 years)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Lilly Clinical Trial RegistryLink provided by the sponsor.
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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.
Call 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
4 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 Pemetrexed Phase 1, Cisplatin Phase 1 and Radiation Therapy in people with Non-Small Cell Lung Cancer, run by Eli Lilly and Company at 4 sites in Canada.
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 7 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 9 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. 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?
Yes. Results are posted in the registry (first posted 28 Sep 2011). 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?
Phase 1: Maximum Tolerated Dose (MTD) of Pemetrexed in Combination With Cisplatin and Radiation Therapy (time frame: Baseline to measured progressive disease (PD; up to 1 year)). 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?
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 9 Jul 2013.