Back to resultsConcurrent Pemetrexed, Cisplatin and Radiation Therapy in Patients With Stage IIIA/B Non Small Cell Lung Cancer
Primary Purpose
Non-Small Cell Lung Cancer
Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Pemetrexed Phase 1
Cisplatin Phase 1
Radiation Therapy
Pemetrexed Phase 2
Cisplatin Phase 2
Sponsored by
About this trial
This is an interventional treatment trial for Non-Small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Sites / Locations
- 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.
- 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.
- 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.
- 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.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Pemetrexed/Cisplatin/Radiation Phase 1
Pemetrexed/Cisplatin/Radiation Phase 2
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Phase 1: Number of Participants With Adverse Events (AE; Toxicity)
A listing of AEs is located in the Reported Adverse Event module.
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.
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.
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.
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).
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00529100
Brief Title
Concurrent Pemetrexed, Cisplatin and Radiation Therapy in Patients With Stage IIIA/B Non Small Cell Lung Cancer
Official Title
A Phase I/II Study of Concurrent Pemetrexed/Cisplatin/Radiation in Stage IIIA/B Non-Small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pemetrexed/Cisplatin/Radiation Phase 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Pemetrexed/Cisplatin/Radiation Phase 2
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Pemetrexed Phase 1
Other Intervention Name(s)
LY231514, Alimta
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Cisplatin Phase 1
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Radiation Therapy
Intervention Description
Phases 1 and 2: 61-65 Gy in 33-35 fractions
Intervention Type
Drug
Intervention Name(s)
Pemetrexed Phase 2
Other Intervention Name(s)
LY231514, Alimta
Intervention Description
Concurrent phase pemetrexed IV bolus as determined by Phase 1 trial to be 500 mg/m^2 IV on Days 1 and 22.
Intervention Type
Drug
Intervention Name(s)
Cisplatin Phase 2
Intervention Description
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.
Primary Outcome Measure Information:
Title
Phase 1: Maximum Tolerated Dose (MTD) of Pemetrexed in Combination With Cisplatin and Radiation Therapy
Description
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.
Time Frame
Baseline to measured progressive disease (PD; up to 1 year)
Title
Phase 2: Percentage of Participants With Overall Survival (OS) at 1 Year
Description
OS was defined as the time from date of enrollment to death due to any cause.
Time Frame
Baseline to date of death from any cause (up to 1 year)
Secondary Outcome Measure Information:
Title
Phase 1: Number of Participants With Adverse Events (AE; Toxicity)
Description
A listing of AEs is located in the Reported Adverse Event module.
Time Frame
Baseline to measured PD (up to 1 year)
Title
Phase 2: Percentage of Participants With Overall Survival (OS) at 2 Years and 3 Years
Description
OS was defined as the time from date of enrollment to death due to any cause.
Time Frame
Baseline and 2 years and 3 years
Title
Phase 2: Time to Progressive Disease (PD)
Description
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.
Time Frame
Baseline to measured PD (up to 3 years)
Title
Phase 2: Percentage of Participants With Progression Free Survival (PFS)
Description
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.
Time Frame
Baseline and 1 year and 2 years and 3 years
Title
Progression Free Survival (PFS)
Description
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).
Time Frame
Baseline to measured PD (up to 36 months)
Title
Phase 2: Percentage of Participants With Objective Tumor Response (Response Rate)
Description
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.
Time Frame
Baseline to measured PD (up to 3 years)
Title
Phase 2: Site of Progressive Disease (PD)
Description
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.
Time Frame
Baseline to measured PD (up to 3 years)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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.
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
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.
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
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.
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
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.
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Concurrent Pemetrexed, Cisplatin and Radiation Therapy in Patients With Stage IIIA/B Non Small Cell Lung Cancer
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