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Chemotherapy in Treating Patients With Non-Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00520676
Recruitment Status : Completed
First Posted : August 24, 2007
Results First Posted : July 18, 2011
Last Update Posted : August 10, 2011
Sponsor:
Information provided by:
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Non-Small Cell Lung Cancer
Interventions Drug: pemetrexed
Drug: docetaxel
Drug: carboplatin
Enrollment 260
Recruitment Details  
Pre-assignment Details Analyses were conducted on the qualified intent-to-treat population (Q-ITT) unless otherwise specified. This population includes all data from all randomized participants, with nonsquamous histology, receiving at least 1 dose of the study drug according to the treatment the participants were assigned.
Arm/Group Title Pemetrexed Plus Carboplatin Docetaxel Plus Carboplatin
Hide Arm/Group Description pemetrexed 500 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days docetaxel 75 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
Period Title: Overall Study
Started 128 132
Received at Least 1 Dose of Study Drug 118 127
Qualified Intent-to-treat (Q-ITT) 106 105
Completed 27 29
Not Completed 101 103
Reason Not Completed
Death             84             81
Lost to Follow-up             6             10
Physician Decision             4             1
Withdrawal by Subject             7             11
Arm/Group Title Pemetrexed Plus Carboplatin Docetaxel Plus Carboplatin Total
Hide Arm/Group Description pemetrexed 500 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days docetaxel 75 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days Total of all reporting groups
Overall Number of Baseline Participants 106 105 211
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 106 participants 105 participants 211 participants
59.6  (10.0) 59.2  (10.7) 59.4  (10.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 106 participants 105 participants 211 participants
Female
42
  39.6%
55
  52.4%
97
  46.0%
Male
64
  60.4%
50
  47.6%
114
  54.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 106 participants 105 participants 211 participants
Taiwan 3 9 12
Mexico 17 22 39
Brazil 35 25 60
Australia 10 14 24
China 20 17 37
Korea, Republic of 21 18 39
Smoking Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 106 participants 105 participants 211 participants
Never Smoking 34 41 75
Ever Smoking but Quit 61 53 114
Currently Smoking 11 11 22
Histology  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 106 participants 105 participants 211 participants
Adenocarcinoma, lung 10 11 21
Adenocarcinoma, not otherwise specified 80 80 160
Large cell carcinoma, lung 10 9 19
Carcinoma, lung 6 5 11
1.Primary Outcome
Title Survival Without Grade 3 or 4 Toxicity
Hide Description

Defined as the time from date of randomization to first date of a Grade 3 or 4 treatment-emergent adverse event (TEAE; as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events [CTCAE], version 3.0) or death due to any cause. Grade 3 TEAE: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated. Grade 4 TEAE: Life-threatening consequences; urgent intervention indicated.

Participants who were alive without experiencing Grade 3 or 4 toxicity were censored at the date of last contact.

Time Frame Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months).
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on protocol-qualified, intent-to-treat (Q-ITT) population. This population includes all data from all randomized participants, with nonsquamous histology, receiving at least 1 dose of the study drug according to the treatment the participants were assigned.
Arm/Group Title Pemetrexed Plus Carboplatin Docetaxel Plus Carboplatin
Hide Arm/Group Description:
pemetrexed 500 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
docetaxel 75 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
Overall Number of Participants Analyzed 106 105
Median (95% Confidence Interval)
Unit of Measure: months
3.2
(2.1 to 3.7)
0.7
(0.5 to 1.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pemetrexed Plus Carboplatin, Docetaxel Plus Carboplatin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The comparison was conducted at a 1-sided significance level of 0.05.
Method Log Rank
Comments Note that the 2-sided p-value for log rank is reported, which is <0.001, hence 1-sided p-value is <0.001.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.45
Confidence Interval (2-Sided) 95%
0.34 to 0.60
Estimation Comments Cox regression model is used for HR estimate.
2.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS is the duration from enrollment to death. For participants who are alive, OS is censored at the last contact.
Time Frame Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months).
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on protocol-qualified, intent-to-treat (Q-ITT) population. This population includes all data from all randomized participants, with nonsquamous histology, receiving at least 1 dose of the study drug according to the treatment the participants were assigned.
Arm/Group Title Pemetrexed Plus Carboplatin Docetaxel Plus Carboplatin
Hide Arm/Group Description:
pemetrexed 500 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
docetaxel 75 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
Overall Number of Participants Analyzed 106 105
Median (95% Confidence Interval)
Unit of Measure: months
14.9
(12.2 to 19.0)
14.7
(10.8 to 19.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pemetrexed Plus Carboplatin, Docetaxel Plus Carboplatin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.934
Comments The comparison was conducted at a 2-sided significance level of 0.05.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.01
Confidence Interval (2-Sided) 95%
0.72 to 1.42
Estimation Comments Cox regression model is used for hazard ratio (HR) estimate.
3.Secondary Outcome
Title Progression-free Survival (PFS)
Hide Description Defined as the time from date of first dose to the first observation of disease progression (PD), or death due to any cause.
Time Frame Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months).
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on protocol-qualified, intent-to-treat (Q-ITT) population. This set includes all data from all randomized participants, with nonsquamous histology, receiving at least 1 dose of the study drug according to the treatment the participants were assigned.
Arm/Group Title Pemetrexed Plus Carboplatin Docetaxel Plus Carboplatin
Hide Arm/Group Description:
pemetrexed 500 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
docetaxel 75 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
Overall Number of Participants Analyzed 106 105
Median (95% Confidence Interval)
Unit of Measure: months
5.8
(4.8 to 6.4)
6.0
(4.8 to 6.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pemetrexed Plus Carboplatin, Docetaxel Plus Carboplatin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.800
Comments The comparison was conducted at a 2-sided significance level of 0.05.
Method Log Rank
Comments Cox regression model is used for hazard ratio (HR) estimate.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.96
Confidence Interval (2-Sided) 95%
0.72 to 1.29
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants With Tumor Response (Response Rate)
Hide Description Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=at least a 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD)=at least a 20% increase in sum of longest diameter of target lesions; Stable Disease (SD)=small changes not meeting above criteria. Response rate (%)=Number of participants with CR+PR/Number of participants analyzed *100. Disease Control rate=Number of participants with SD+PR+CR/Number of participants analyzed *100.
Time Frame Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months).
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on tumour response-qualified population. This population includes all participants with locally advanced or metastatic non-small cell lung cancer (NSCLC), non-squamous histology with measurable disease as defined by RECIST (Version 1.0), who received at least 1 dose of pemetrexed, docetaxel, or carboplatin.
Arm/Group Title Pemetrexed Plus Carboplatin Docetaxel Plus Carboplatin
Hide Arm/Group Description:
pemetrexed 500 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
docetaxel 75 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
Overall Number of Participants Analyzed 106 104
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Tumor Response Rate
34.0
(25.0 to 43.8)
23.1
(15.4 to 32.4)
Disease Control Rate
74.5
(65.1 to 82.5)
64.4
(54.4 to 73.6)
Complete Response
0.9
(0.0 to 5.1)
0
(0 to 3.5)
Partial Response
33.0
(24.2 to 42.8)
23.1
(15.4 to 32.4)
Stable Disease
40.6
(31.1 to 50.5)
41.3
(31.8 to 51.4)
Progressive Disease
16.0
(9.6 to 24.4)
17.3
(10.6 to 26.0)
Unknown
9.4
(4.6 to 16.7)
18.3
(11.4 to 27.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pemetrexed Plus Carboplatin, Docetaxel Plus Carboplatin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.081
Comments The comparison of tumor response rates was conducted at a 2-sided significance level of 0.05.
Method Fisher Exact
Comments Tumor response rate= # participants with a confirmed best response of CR or PR / # of participants who qualify for the analysis population.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.71
Confidence Interval (2-Sided) 95%
0.93 to 3.15
Estimation Comments Logistic regression model is used for odds ratio (OR) estimate.
5.Secondary Outcome
Title Survival Without Clinically Important Grade 3 or 4 Toxicity
Hide Description Survival without Grade 3 or 4 toxicity is the time from date of randomization to the first date of the following clinically important Grade 3 or 4 TEAEs graded by the Common Terminology Criteria for Adverse Events [CTCAE], version 3.0: neutropenia (lasting >5 days), febrile neutropenia, documented infections related to neutropenia, anemia, thrombocytopenia, fatigue, nausea, vomiting, diarrhea, stomatitis, and neurosensory events; or death due to any cause. Participants who were alive without experiencing Grade 3 or 4 toxicity were censored for this analysis at the date of last contact.
Time Frame Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months).
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on protocol-qualified, intent-to-treat (Q-ITT) population. This population includes all data from all randomized participants, with nonsquamous histology, receiving at least one dose of the study drug according to the treatment the participants were assigned.
Arm/Group Title Pemetrexed Plus Carboplatin Docetaxel Plus Carboplatin
Hide Arm/Group Description:
pemetrexed 500 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
docetaxel 75 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
Overall Number of Participants Analyzed 106 105
Median (95% Confidence Interval)
Unit of Measure: months
3.6
(3.0 to 8.0)
1.3
(1.1 to 1.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pemetrexed Plus Carboplatin, Docetaxel Plus Carboplatin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The comparison was conducted at a 2-sided significance level of 0.05.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.53
Confidence Interval (2-Sided) 95%
0.40 to 0.71
Estimation Comments Cox regression model is used for unadjusted hazard ratio (HR) estimate.
6.Secondary Outcome
Title Survival Without Grade 4 Toxicity
Hide Description Survival without Grade 4 toxicity is the time from the date of randomization to the first date of a Grade 4 TEAE or death due to any cause. Participants who are alive without experiencing Grade 4 toxicity will be censored for this analysis at the date of last contact.
Time Frame Baseline to until 218 events (defined as death or Grade 4 toxicity) have been observed (up to 33.3 months).
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on protocol-qualified, intent-to-treat (Q-ITT) population. This population includes all data from all randomized participants, with nonsquamous histology, receiving at least 1 dose of the study drug according to the treatment the participants were assigned.
Arm/Group Title Pemetrexed Plus Carboplatin Docetaxel Plus Carboplatin
Hide Arm/Group Description:
pemetrexed 500 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
docetaxel 75 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
Overall Number of Participants Analyzed 106 105
Median (95% Confidence Interval)
Unit of Measure: participants
12.2
(8.4 to 14.9)
2.0
(1.6 to 3.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pemetrexed Plus Carboplatin, Docetaxel Plus Carboplatin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The comparison was conducted at a 2-sided significance level of 0.05.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.49
Confidence Interval (2-Sided) 95%
0.35 to 0.66
Estimation Comments Cox regression model is used for unadjusted hazard ratio (HR) estimate.
7.Secondary Outcome
Title Number of Participants With Adverse Events (AEs)
Hide Description Summaries of serious AEs (SAEs) and all other non-serious AEs are located in the Reported Adverse Event Module.
Time Frame Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months).
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on safety population. This population includes all participants with non-squamous histology who received at least one dose of study drug. Participants were analysed according to treatments they actually received.
Arm/Group Title Pemetrexed Plus Carboplatin Docetaxel Plus Carboplatin
Hide Arm/Group Description:
pemetrexed 500 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
docetaxel 75 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
Overall Number of Participants Analyzed 106 105
Measure Type: Number
Unit of Measure: participants
Non-Serious Adverse Events (AEs) 94 100
Serious Adverse Events (SAEs) 28 35
8.Other Pre-specified Outcome
Title Duration of Response
Hide Description The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. CR=disappearance of all target lesions; PR=at least a 30% decrease in sum of longest diameter of target lesions.
Time Frame Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months).
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on tumour response qualified population. This population includes all participants with locally advanced or metastatic non-small cell lung cancer (NSCLC), non-squamous histology with measurable disease as defined by RECIST (Version 1.0), who received at least 1 dose of pemetrexed, docetaxel, or carboplatin.
Arm/Group Title Pemetrexed Plus Carboplatin Docetaxel Plus Carboplatin
Hide Arm/Group Description:
pemetrexed 500 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
docetaxel 75 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
Overall Number of Participants Analyzed 106 104
Median (95% Confidence Interval)
Unit of Measure: months
5.5
(4.0 to 8.1)
5.4
(4.4 to 6.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pemetrexed Plus Carboplatin, Docetaxel Plus Carboplatin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.641
Comments The comparison was conducted at a 2-sided significance level of 0.05.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.87
Confidence Interval (2-Sided) 95%
0.49 to 1.55
Estimation Comments Cox regression model is used for hazard ratio (HR) estimate.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pemetrexed Plus Carboplatin Docetaxel Plus Carboplatin
Hide Arm/Group Description pemetrexed 500 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days docetaxel 75 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
All-Cause Mortality
Pemetrexed Plus Carboplatin Docetaxel Plus Carboplatin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Pemetrexed Plus Carboplatin Docetaxel Plus Carboplatin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   28/106 (26.42%)      35/105 (33.33%)    
Blood and lymphatic system disorders     
Anaemia  1  2/106 (1.89%)  2 0/105 (0.00%)  0
Febrile neutropenia  1  0/106 (0.00%)  0 9/105 (8.57%)  10
Haematotoxicity  1  1/106 (0.94%)  1 0/105 (0.00%)  0
Leukopenia  1  1/106 (0.94%)  1 3/105 (2.86%)  3
Neutropenia  1  2/106 (1.89%)  2 8/105 (7.62%)  9
Pancytopenia  1  2/106 (1.89%)  2 0/105 (0.00%)  0
Thrombocytopenia  1  3/106 (2.83%)  3 2/105 (1.90%)  2
Cardiac disorders     
Acute myocardial infarction  1  0/106 (0.00%)  0 1/105 (0.95%)  1
Arrhythmia  1  1/106 (0.94%)  1 1/105 (0.95%)  1
Atrial fibrillation  1  0/106 (0.00%)  0 3/105 (2.86%)  3
Cardiac arrest  1  0/106 (0.00%)  0 1/105 (0.95%)  1
Cor pulmonale  1  1/106 (0.94%)  1 0/105 (0.00%)  0
Tachycardia  1  1/106 (0.94%)  1 0/105 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain  1  1/106 (0.94%)  1 0/105 (0.00%)  0
Diarrhoea  1  0/106 (0.00%)  0 3/105 (2.86%)  3
Lower gastrointestinal haemorrhage  1  1/106 (0.94%)  1 0/105 (0.00%)  0
Nausea  1  0/106 (0.00%)  0 1/105 (0.95%)  1
Vomiting  1  1/106 (0.94%)  1 2/105 (1.90%)  2
General disorders     
Asthenia  1  1/106 (0.94%)  1 2/105 (1.90%)  2
Chest pain  1  0/106 (0.00%)  0 1/105 (0.95%)  1
Death  1  1/106 (0.94%)  1 0/105 (0.00%)  0
Pain  1  1/106 (0.94%)  1 0/105 (0.00%)  0
Pyrexia  1  1/106 (0.94%)  1 2/105 (1.90%)  2
Immune system disorders     
Anaphylactic shock  1  0/106 (0.00%)  0 1/105 (0.95%)  1
Infections and infestations     
Bronchopulmonary aspergillosis  1  1/106 (0.94%)  1 0/105 (0.00%)  0
Device related infection  1  0/106 (0.00%)  0 1/105 (0.95%)  1
Pharyngitis  1  0/106 (0.00%)  0 1/105 (0.95%)  1
Pneumonia  1  5/106 (4.72%)  5 7/105 (6.67%)  7
Pneumonia bacterial  1  0/106 (0.00%)  0 1/105 (0.95%)  1
Septic shock  1  1/106 (0.94%)  1 1/105 (0.95%)  1
Investigations     
Body temperature increased  1  1/106 (0.94%)  1 0/105 (0.00%)  0
Platelet count decreased  1  1/106 (0.94%)  1 0/105 (0.00%)  0
Troponin increased  1  0/106 (0.00%)  0 1/105 (0.95%)  1
Metabolism and nutrition disorders     
Decreased appetite  1  1/106 (0.94%)  1 0/105 (0.00%)  0
Dehydration  1  0/106 (0.00%)  0 1/105 (0.95%)  1
Musculoskeletal and connective tissue disorders     
Back pain  1  1/106 (0.94%)  1 0/105 (0.00%)  0
Nervous system disorders     
Cerebrovascular accident  1  1/106 (0.94%)  1 0/105 (0.00%)  0
Convulsion  1  1/106 (0.94%)  1 0/105 (0.00%)  0
Neuralgia  1  1/106 (0.94%)  1 0/105 (0.00%)  0
Psychiatric disorders     
Anxiety  1  0/106 (0.00%)  0 1/105 (0.95%)  1
Renal and urinary disorders     
Renal failure  1  1/106 (0.94%)  1 1/105 (0.95%)  1
Reproductive system and breast disorders     
Prostatitis  1  1/106 (0.94%)  1 0/105 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure  1  1/106 (0.94%)  1 1/105 (0.95%)  1
Asphyxia  1  0/106 (0.00%)  0 1/105 (0.95%)  1
Bronchospasm  1  1/106 (0.94%)  1 0/105 (0.00%)  0
Dyspnoea  1  0/106 (0.00%)  0 3/105 (2.86%)  3
Haemoptysis  1  1/106 (0.94%)  1 1/105 (0.95%)  1
Pleural effusion  1  0/106 (0.00%)  0 1/105 (0.95%)  1
Pleuritic pain  1  0/106 (0.00%)  0 1/105 (0.95%)  1
Pulmonary embolism  1  1/106 (0.94%)  1 1/105 (0.95%)  1
Respiratory failure  1  0/106 (0.00%)  0 3/105 (2.86%)  3
Vascular disorders     
Arterial occlusive disease  1  1/106 (0.94%)  1 0/105 (0.00%)  0
Deep vein thrombosis  1  2/106 (1.89%)  2 0/105 (0.00%)  0
Hypotension  1  0/106 (0.00%)  0 1/105 (0.95%)  1
Superior vena caval occlusion  1  1/106 (0.94%)  1 1/105 (0.95%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pemetrexed Plus Carboplatin Docetaxel Plus Carboplatin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   94/106 (88.68%)      100/105 (95.24%)    
Blood and lymphatic system disorders     
Anaemia  1  36/106 (33.96%)  46 18/105 (17.14%)  25
Leukopenia  1  33/106 (31.13%)  80 56/105 (53.33%)  139
Lymphopenia  1  14/106 (13.21%)  26 25/105 (23.81%)  38
Neutropenia  1  40/106 (37.74%)  109 74/105 (70.48%)  203
Thrombocytopenia  1  12/106 (11.32%)  23 4/105 (3.81%)  6
Cardiac disorders     
Arrhythmia  1  3/106 (2.83%)  3 6/105 (5.71%)  6
Gastrointestinal disorders     
Abdominal pain  1  11/106 (10.38%)  14 13/105 (12.38%)  16
Constipation  1  18/106 (16.98%)  23 15/105 (14.29%)  17
Diarrhoea  1  12/106 (11.32%)  21 30/105 (28.57%)  43
Dyspepsia  1  5/106 (4.72%)  6 7/105 (6.67%)  8
Nausea  1  43/106 (40.57%)  71 37/105 (35.24%)  66
Stomatitis  1  9/106 (8.49%)  17 11/105 (10.48%)  16
Vomiting  1  18/106 (16.98%)  22 19/105 (18.10%)  31
General disorders     
Asthenia  1  15/106 (14.15%)  20 19/105 (18.10%)  30
Chest pain  1  4/106 (3.77%)  4 7/105 (6.67%)  7
Fatigue  1  13/106 (12.26%)  15 21/105 (20.00%)  24
Mucosal inflammation  1  7/106 (6.60%)  11 5/105 (4.76%)  7
Oedema  1  4/106 (3.77%)  4 6/105 (5.71%)  6
Pyrexia  1  11/106 (10.38%)  12 7/105 (6.67%)  15
Infections and infestations     
Conjunctivitis infective  1  7/106 (6.60%)  8 0/105 (0.00%)  0
Nail infection  1  0/106 (0.00%)  0 7/105 (6.67%)  7
Investigations     
Alanine aminotransferase increased  1  9/106 (8.49%)  11 3/105 (2.86%)  3
Platelet count decreased  1  7/106 (6.60%)  13 5/105 (4.76%)  11
Weight decreased  1  3/106 (2.83%)  3 6/105 (5.71%)  6
Metabolism and nutrition disorders     
Decreased appetite  1  27/106 (25.47%)  37 30/105 (28.57%)  35
Hyponatraemia  1  4/106 (3.77%)  4 6/105 (5.71%)  6
Musculoskeletal and connective tissue disorders     
Myalgia  1  3/106 (2.83%)  3 8/105 (7.62%)  11
Nervous system disorders     
Dizziness  1  7/106 (6.60%)  8 7/105 (6.67%)  7
Dysgeusia  1  7/106 (6.60%)  12 11/105 (10.48%)  15
Headache  1  8/106 (7.55%)  9 7/105 (6.67%)  9
Neurotoxicity  1  2/106 (1.89%)  2 7/105 (6.67%)  11
Paraesthesia  1  0/106 (0.00%)  0 7/105 (6.67%)  8
Peripheral sensory neuropathy  1  7/106 (6.60%)  10 14/105 (13.33%)  18
Psychiatric disorders     
Insomnia  1  7/106 (6.60%)  7 6/105 (5.71%)  7
Respiratory, thoracic and mediastinal disorders     
Cough  1  13/106 (12.26%)  14 8/105 (7.62%)  8
Dyspnoea  1  10/106 (9.43%)  10 10/105 (9.52%)  10
Epistaxis  1  8/106 (7.55%)  9 2/105 (1.90%)  3
Skin and subcutaneous tissue disorders     
Alopecia  1  10/106 (9.43%)  11 45/105 (42.86%)  46
Pruritus  1  7/106 (6.60%)  8 5/105 (4.76%)  5
Rash  1  8/106 (7.55%)  9 9/105 (8.57%)  9
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
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: Chief Medical Officer, Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00520676    
Other Study ID Numbers: 11626
H3E-CR-S380 ( Other Identifier: Eli Lilly and Company )
First Submitted: August 22, 2007
First Posted: August 24, 2007
Results First Submitted: June 17, 2011
Results First Posted: July 18, 2011
Last Update Posted: August 10, 2011