Back to resultsPemetrexed/Carboplatin Non-Small Cell Lung Cancer (NSCLC) Elderly Patients
Primary Purpose
Non Small Cell Lung Cancer
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
pemetrexed
carboplatin
Sponsored by
About this trial
This is an interventional treatment trial for Non Small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
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.
- 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 Type
Experimental
Arm Label
Pemetrexed + Carboplatin
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Overall Survival
Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00350792
Brief Title
Pemetrexed/Carboplatin Non-Small Cell Lung Cancer (NSCLC) Elderly Patients
Official Title
A Phase II Trial Pemetrexed Carboplatin as First Line Chemotherapy for Advanced Non-Small Cell Lung Cancer (NSCLC) in Elderly Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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
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 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pemetrexed + Carboplatin
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
pemetrexed
Other Intervention Name(s)
LY231514, Alimta
Intervention Description
500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 6 cycles
Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Description
Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
Primary Outcome Measure Information:
Title
Percentage of Participants With a Complete or Partial Tumor Response (Overall Tumor Response)
Description
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.
Time Frame
baseline to measured objective tumor response (up to six 21-day cycles)
Secondary Outcome Measure Information:
Title
Time to Treatment Failure
Description
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.
Time Frame
baseline to stopping treatment (up to six 21-day cycles)
Title
Overall Survival
Description
Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.
Time Frame
baseline to date of death from any cause (up to 14.5 months)
Title
Estimated Probability of One Year Progression-free Survival
Description
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.
Time Frame
baseline to measured progressive disease or death, 1 year
Other Pre-specified Outcome Measures:
Title
Time to Treatment Failure
Description
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.
Time Frame
baseline to stopping treatment (up to six 21-day cycles)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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
Bobigny
ZIP/Postal Code
93009
Country
France
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
Brest
ZIP/Postal Code
29609
Country
France
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
Caen
ZIP/Postal Code
14076
Country
France
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
Le Mans
ZIP/Postal Code
72000
Country
France
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
Lille
ZIP/Postal Code
59000
Country
France
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
Nantes
ZIP/Postal Code
44202
Country
France
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
Vandoeuvre Les Nancy
ZIP/Postal Code
54511
Country
France
12. IPD Sharing Statement
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Pemetrexed/Carboplatin Non-Small Cell Lung Cancer (NSCLC) Elderly Patients
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