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Molecular Profiling in Lung Cancer Patients

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ClinicalTrials.gov Identifier: NCT00191308
Recruitment Status : Completed
First Posted : September 19, 2005
Results First Posted : April 20, 2010
Last Update Posted : October 21, 2011
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Non-Small Cell Lung Cancer
Carcinoma
Interventions Drug: pemetrexed
Drug: cisplatin
Procedure: Radical Non-Small Cell Lung Cancer (NSCLC) surgery
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pemetrexed + Cisplatin
Hide Arm/Group Description

Pemetrexed: 500 milligram 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.

Period Title: Overall Study
Started 30
Completed 29
Not Completed 1
Reason Not Completed
Adverse Event             1
Arm/Group Title Pemetrexed + Cisplatin
Hide Arm/Group Description

Pemetrexed: 500 milligram 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.

Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants
55.94  (8.214)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
1
   3.3%
Male
29
  96.7%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Caucasian Number Analyzed 30 participants
30
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Poland Number Analyzed 30 participants
30
Basis for Diagnosis  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 30 participants
Histopathological 30
Cytological 0
Initial Pathological Diagnosis   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 30 participants
Adenocarcinoma of Lung 2
Mixed Cell Carcinoma of Lung 0
Squamous Cell Carcinoma of Lung 20
Large Cell Carcinoma of Lung 0
Bronchoalveolar Carcinoma 0
Other 8
[1]
Measure Description: Pemetrexed was approved in April 2008 for first- and second-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC), other than predominantly squamous. Of the 30 participants enrolled at that time, 20 had squamous cell histology. The protocol was not amended since enrollment stopped early (October 2008) due to lack of eligible participants.
Stage of Disease at Study Entry   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 30 participants
Stage IB 18
Stage IIA 2
Stage IIB 10
[1]
Measure Description: Tumor stages ranged from 0 (not spread) to IV (spread throughout the body). Stage IB=tumor was larger or grew deeper than IA, but was not in the lymph nodes; Stage IIA=cancer spread to some lymph nodes near the original tumor; Stage IIB=cancer was not in the lymph nodes but in the chest wall region, or was a larger tumor in the lymph nodes.
1.Primary Outcome
Title High/Low Expression of Selected Molecular Markers in Tumor Tissues and Hypermethylated Genes in Peripheral Blood
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Due to lack of eligible participants, enrollment was stopped early when 30 participants were enrolled. Tumor samples were collected in only 19 of these 30 participants. Results obtained from analyses of a small number of available samples were considered to be of little scientific and medical relevance, and tumor-tissue analyses were not conducted.
Arm/Group Title Pemetrexed + Cisplatin
Hide Arm/Group Description:

Pemetrexed: 500 milligram 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.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Percentage of Participants With Objective Tumor Response (Response Rate)
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Tumor response rate and 95% confidence interval (CI) of best CR or PR were evaluated on all qualified enrolled participants treated with at least 1 dose of study medication. Criteria=histological or cytological diagnosis of non-small cell lung cancer (NSCLC) IB-IIIA; presence of measurable disease; no previous NSCLC chemotherapy and radiotherapy.
Arm/Group Title Pemetrexed + Cisplatin
Hide Arm/Group Description:

Pemetrexed: 500 milligram 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.

Overall Number of Participants Analyzed 29
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
34.5
(17.9 to 54.3)
3.Secondary Outcome
Title Duration of Response
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Duration of response was analyzed on responders treated with at least 1 dose of study medication. Criteria=histological or cytological diagnosis of non-small cell lung cancer (NSCLC) IB-IIIA; presence of measurable disease; no previous NSCLC chemotherapy and radiotherapy; responder.
Arm/Group Title Pemetrexed + Cisplatin
Hide Arm/Group Description:

Pemetrexed: 500 milligram 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.

Overall Number of Participants Analyzed 10
Median (95% Confidence Interval)
Unit of Measure: months
42.5 [1] 
(8.31 to NA)
[1]
The upper limit of the 95% confidence interval (CI) was not calculable because an insufficient number of participants reached the event at the final time point for assessment.
4.Secondary Outcome
Title Disease Free Survival (DFS)
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
DFS was evaluated on all qualified enrolled patients who received at least 1 dose of study medication. Criteria=histological or cytological diagnosis of non-small cell lung cancer (NSCLC) IB-IIIA; presence of measurable disease; no previous NSCLC chemotherapy and radiotherapy.
Arm/Group Title Pemetrexed + Cisplatin
Hide Arm/Group Description:

Pemetrexed: 500 milligram 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.

Overall Number of Participants Analyzed 29
Median (95% Confidence Interval)
Unit of Measure: months
43.7 [1] 
(25.36 to NA)
[1]
The upper limit of the 95% confidence interval (CI) was not calculable because an insufficient number of participants reached the event at the final time point for assessment.
5.Secondary Outcome
Title Overall Survival (OS)
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
OS was evaluated on all qualified enrolled patients who received at least 1 dose of study medication.
Arm/Group Title Pemetrexed + Cisplatin
Hide Arm/Group Description:

Pemetrexed: 500 milligram 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.

Overall Number of Participants Analyzed 29
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(31.15 to NA)
[1]
The median and upper limit of the 95% confidence interval (CI) were not calculable because an insufficient number of participants reached the event at the final time point for assessment.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pemetrexed + Cisplatin
Hide Arm/Group Description

Pemetrexed: 500 milligram 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.

All-Cause Mortality
Pemetrexed + Cisplatin
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Pemetrexed + Cisplatin
Affected / at Risk (%) # Events
Total   4/30 (13.33%)    
Gastrointestinal disorders   
Gastric ulcer  1  1/30 (3.33%)  1
Injury, poisoning and procedural complications   
Post procedural haemorrhage  1  1/30 (3.33%)  1
Respiratory, thoracic and mediastinal disorders   
Bronchopleural fistula  1  2/30 (6.67%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pemetrexed + Cisplatin
Affected / at Risk (%) # Events
Total   19/30 (63.33%)    
Investigations   
Alanine aminotransferase increased  1  4/30 (13.33%)  4
Aspartate aminotransferase increased  1  4/30 (13.33%)  4
Weight increased  1  4/30 (13.33%)  4
Metabolism and nutrition disorders   
Hyperkalaemia  1  3/30 (10.00%)  3
Hypernatraemia  1  2/30 (6.67%)  2
Skin and subcutaneous tissue disorders   
Rash  1  2/30 (6.67%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.1
Trial enrollment was terminated early due to lack of eligible participants.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00191308    
Other Study ID Numbers: 9356
H3E-PL-S051 ( Other Identifier: Eli Lilly and Company )
First Submitted: September 12, 2005
First Posted: September 19, 2005
Results First Submitted: March 16, 2010
Results First Posted: April 20, 2010
Last Update Posted: October 21, 2011