Back to resultsMolecular Profiling in Lung Cancer Patients
Primary Purpose
Non-Small Cell Lung Cancer, Carcinoma
Status
Completed
Phase
Phase 2
Locations
Poland
Study Type
Interventional
Intervention
pemetrexed
cisplatin
Radical Non-Small Cell Lung Cancer (NSCLC) surgery
Sponsored by
About this trial
This is an interventional treatment trial for Non-Small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria: pathologic documentation of non-small cell lung cancer (NSCLC) tumor must be accessible by bronchoscopy for tumor tissue sample collection patients must have lung cancer with clinical stage IB, II, IIIA Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 patients must not have received prior systemic chemotherapy or radiation therapy for NSCLC (prior resection of lung is allowed provided at least 5 years have elapsed between prior surgery and enrolment) Exclusion Criteria: bronchoalveolar carcinoma or stage IIIA tumor involving the superior sulcus (Pancoast tumors) pregnant or breast feeding patients patients who have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry patients with history or presence of other malignancy except in situ carcinoma of the skin or prior malignancy treated more than 5 years before without recurrence (excluding melanoma, breast cancer and hypernephroma) unwillingness to take folic acid or vitamin B12 supplementation
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.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pemetrexed + Cisplatin
Arm Description
Pemetrexed: 500 milligrams per square meter (mg/m^2) intravenous (IV) every 21 days (q 21 days) for 3 cycles unless disease progression occurs Cisplatin: 75 mg/m^2 IV q 21 days for 3 cycles unless disease progression occurs
Outcomes
Primary Outcome Measures
High/Low Expression of Selected Molecular Markers in Tumor Tissues and Hypermethylated Genes in Peripheral Blood
Molecular markers assessed by immunohistochemistry: thymidylate synthase, glycinamide ribonucleotide formyl transferase (GARFT), epidermal growth factor receptor (EGFR); and by polymerase chain reaction: dihydrofolate reductase (DHFR), dihydropyrimidine dehydrogenase (DPD), folylpolyglutamate synthetase (FPGS), reduced folate carrier, alpha folate receptor, Excision Repair Cross-Complementation Group 1 (ERCC1), folylpolyglutamate hydrolase (FPGH). Hypermethylated genes assessed by methylation-specific polymerase chain reaction. Due to small sample size, tumor-tissue analyses were not done.
Secondary Outcome Measures
Percentage of Participants With Objective Tumor Response (Response Rate)
Tumor response to treatment using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. 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. Response rate was estimated as the total number of CR or PR, divided by the total number of participants treated.
Duration of Response
The duration of response was defined as the time from complete response (CR) or partial response (PR) to disease progression. 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.
Disease Free Survival (DFS)
DFS was the time from date of first dose to first observation of progressive disease (PD) or death due to any cause. PD=20% increase in sum of longest diameter of target lesions. If a participant was not known to have died or have PD, DFS was censored at the date of the last objective progression-free disease assessment.
Overall Survival (OS)
OS was defined as the time from treatment start to death from any cause. For participants who were alive, OS was censored at the last contact date.
Full Information
NCT ID
NCT00191308
First Posted
September 12, 2005
Last Updated
October 13, 2011
Sponsor
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT00191308
Brief Title
Molecular Profiling in Lung Cancer Patients
Official Title
Molecular Profiling and Safety Study of Operable Lung Cancer Patients Treated With Alimta Combined With Cisplatin as Neoadjuvant Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
December 2010 (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
The main purpose of this study of pemetrexed combined with cisplatin used as neoadjuvant chemotherapy (2 or 3 cycles) in participants with operable non-small cell lung cancer (NSCLC) is to look at various genes present in participants' blood and tumor tissue to see if there is any link between the levels or changes in the genes and how participants with lung cancer respond to pemetrexed and cisplatin treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer, Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pemetrexed + Cisplatin
Arm Type
Experimental
Arm Description
Pemetrexed: 500 milligrams per square meter (mg/m^2) intravenous (IV) every 21 days (q 21 days) for 3 cycles unless disease progression occurs
Cisplatin: 75 mg/m^2 IV q 21 days for 3 cycles unless disease progression occurs
Intervention Type
Drug
Intervention Name(s)
pemetrexed
Other Intervention Name(s)
LY231514, Alimta
Intervention Description
500 mg/m^2 IV q 21 days for 3 cycles unless disease progression occurs
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Description
75 mg/m^2 IV q 21 days for 3 cycles unless disease progression occurs
Intervention Type
Procedure
Intervention Name(s)
Radical Non-Small Cell Lung Cancer (NSCLC) surgery
Intervention Description
All participants proceeded to surgery within 4-8 weeks from the last dose of pemetrexed.
Primary Outcome Measure Information:
Title
High/Low Expression of Selected Molecular Markers in Tumor Tissues and Hypermethylated Genes in Peripheral Blood
Description
Molecular markers assessed by immunohistochemistry: thymidylate synthase, glycinamide ribonucleotide formyl transferase (GARFT), epidermal growth factor receptor (EGFR); and by polymerase chain reaction: dihydrofolate reductase (DHFR), dihydropyrimidine dehydrogenase (DPD), folylpolyglutamate synthetase (FPGS), reduced folate carrier, alpha folate receptor, Excision Repair Cross-Complementation Group 1 (ERCC1), folylpolyglutamate hydrolase (FPGH). Hypermethylated genes assessed by methylation-specific polymerase chain reaction. Due to small sample size, tumor-tissue analyses were not done.
Time Frame
Baseline, Cycle 2, and surgery (4-8 weeks after last dose of pemetrexed)
Secondary Outcome Measure Information:
Title
Percentage of Participants With Objective Tumor Response (Response Rate)
Description
Tumor response to treatment using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. 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. Response rate was estimated as the total number of CR or PR, divided by the total number of participants treated.
Time Frame
Treatment start to disease progression or surgery (4-8 weeks after last dose of pemetrexed)
Title
Duration of Response
Description
The duration of response was defined as the time from complete response (CR) or partial response (PR) to disease progression. 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.
Time Frame
Time of response to disease progression (up to 44.4 months)
Title
Disease Free Survival (DFS)
Description
DFS was the time from date of first dose to first observation of progressive disease (PD) or death due to any cause. PD=20% increase in sum of longest diameter of target lesions. If a participant was not known to have died or have PD, DFS was censored at the date of the last objective progression-free disease assessment.
Time Frame
Treatment start to disease progression or death from any cause (up to 45.5 months)
Title
Overall Survival (OS)
Description
OS was defined as the time from treatment start to death from any cause. For participants who were alive, OS was censored at the last contact date.
Time Frame
Treatment start to death from any cause (up to 47.6 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
pathologic documentation of non-small cell lung cancer (NSCLC)
tumor must be accessible by bronchoscopy for tumor tissue sample collection
patients must have lung cancer with clinical stage IB, II, IIIA
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
patients must not have received prior systemic chemotherapy or radiation therapy for NSCLC (prior resection of lung is allowed provided at least 5 years have elapsed between prior surgery and enrolment)
Exclusion Criteria:
bronchoalveolar carcinoma or stage IIIA tumor involving the superior sulcus (Pancoast tumors)
pregnant or breast feeding patients
patients who have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
patients with history or presence of other malignancy except in situ carcinoma of the skin or prior malignancy treated more than 5 years before without recurrence (excluding melanoma, breast cancer and hypernephroma)
unwillingness to take folic acid or vitamin B12 supplementation
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
Bystra Slaska
ZIP/Postal Code
43-360
Country
Poland
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
Poznan
ZIP/Postal Code
60-569
Country
Poland
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
Warsaw
ZIP/Postal Code
02-781
Country
Poland
12. IPD Sharing Statement
Learn more about this trial
Molecular Profiling in Lung Cancer Patients
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