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To Investigate Efficacy and Safety of Pemetrexed as Second or Third Line Therapy in Patients With Non-small Cell Lung Cancer (NSCLC)

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: NCT00191191
Recruitment Status : Completed
First Posted : September 19, 2005
Results First Posted : November 25, 2009
Last Update Posted : December 9, 2009
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 500 mg/m2
Drug: Pemetrexed 1000 mg/m2
Enrollment 226
Recruitment Details  
Pre-assignment Details Baseline demographics and efficacy outcome measures are provided for the Full Analysis Set population (all randomized participants who met all inclusion and no exclusion criteria and received at least one dose of study drug).
Arm/Group Title Pemetrexed 500 mg/m2 Pemetrexed 1000 mg/m2
Hide Arm/Group Description Pemetrexed 500 mg/m2, intravenous, every 21 days Pemetrexed 1000 mg/m2, intravenous, every 21 days
Period Title: Overall Study
Started 114 112
Safety Analysis Population 114 111
Full Analysis Set Population 108 108
Completed 0 0
Not Completed 114 112
Reason Not Completed
Entry Criteria Exclusion             2             0
Treated with Another Systemic Agent             1             1
Adverse Event             11             21
Progressive Disease             84             72
Toxicity After Dose Reduction             7             8
Family/Caregiver Decision             5             7
Lost to Follow-up             1             0
Physician Decision             3             2
Good Clinical Practice Violation             0             1
Arm/Group Title Pemetrexed 500 mg/m2 Pemetrexed 1000 mg/m2 Total
Hide Arm/Group Description Pemetrexed 500 mg/m2, intravenous, every 21 days Pemetrexed 1000 mg/m2, intravenous, every 21 days Total of all reporting groups
Overall Number of Baseline Participants 108 108 216
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 108 participants 108 participants 216 participants
60.8  (8.7) 61.3  (8.8) 61.1  (8.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 108 participants 108 participants 216 participants
Female
40
  37.0%
39
  36.1%
79
  36.6%
Male
68
  63.0%
69
  63.9%
137
  63.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 108 participants 108 participants 216 participants
108 108 216
Eastern Cooperative Oncology Group (ECOG) Performance Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 108 participants 108 participants 216 participants
0 - Fully Active 43 36 79
1 - Ambulatory, Restricted Strenuous Activity 59 66 125
2 - Ambulatory, No Work Activities 6 6 12
[1]
Measure Description: Classifies patients according to their functional impairment. Scores range from 0 (Fully Active) to 5 (Death).
Histological Types  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 108 participants 108 participants 216 participants
Adenocarcinoma 77 80 157
Squamous Cell Carcinoma 23 25 48
Large Cell Carcinoma 5 1 6
Adenosquamous Carcinoma 1 0 1
Other 2 2 4
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeters (cm)
Number Analyzed 108 participants 108 participants 216 participants
161.0  (7.9) 161.1  (8.7) 161.0  (8.3)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 108 participants 108 participants 216 participants
59.8  (9.9) 59.1  (11.9) 59.5  (10.9)
1.Primary Outcome
Title Best Overall Response
Hide Description Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria as determined by the Case Judgment Committee. Best overall response was defined as the most favorable overall response recorded for each patient during the observation period. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.
Time Frame baseline to measured progressive disease (up to 3.2 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set: all randomized participants who met all of the inclusion criteria and none of the exclusion criteria and received at least one dose of study drug.
Arm/Group Title Pemetrexed 500 mg/m2 Pemetrexed 1000 mg/m2
Hide Arm/Group Description:
Pemetrexed 500 mg/m2, intravenous, every 21 days
Pemetrexed 1000 mg/m2, intravenous, every 21 days
Overall Number of Participants Analyzed 108 108
Measure Type: Number
Unit of Measure: participants
Complete Response (CR) 0 0
Partial Response (PR) 20 16
Stable Disease (SD) 40 34
Progressive Disease (PD) 48 58
2.Secondary 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.
Time Frame time of response to progressive disease (up to 3.2 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set: all randomized participants who met all of the inclusion criteria and none of the exclusion criteria and received at least one dose of study drug.
Arm/Group Title Pemetrexed 500 mg/m2 Pemetrexed 1000 mg/m2
Hide Arm/Group Description:
Pemetrexed 500 mg/m2, intravenous, every 21 days
Pemetrexed 1000 mg/m2, intravenous, every 21 days
Overall Number of Participants Analyzed 108 108
Median (95% Confidence Interval)
Unit of Measure: months
4.9
(3.8 to 8.7)
3.0
(2.8 to 6.1)
3.Secondary Outcome
Title Progression-Free Survival (PFS)
Hide Description PFS was defined as time from the scheduled date of the first treatment cycle until the date of confirmation of progressive disease on the overall response rating. For patients who died before confirmation of progressive disease, the number of days until the date of death (from any cause) was handled as progression-free survival.
Time Frame baseline to measured progressive disease (up to 3.2 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set: all randomized participants who met all of the inclusion criteria and none of the exclusion criteria and received at least one dose of study drug.
Arm/Group Title Pemetrexed 500 mg/m2 Pemetrexed 1000 mg/m2
Hide Arm/Group Description:
Pemetrexed 500 mg/m2, intravenous, every 21 days
Pemetrexed 1000 mg/m2, intravenous, every 21 days
Overall Number of Participants Analyzed 108 108
Median (95% Confidence Interval)
Unit of Measure: months
3.0
(2.0 to 3.5)
2.5
(1.8 to 3.2)
4.Secondary Outcome
Title Change From Baseline to 3 Months in Quality of Life Questionnaire for Cancer Patients Treated With Anticancer Drugs (QOL-ACD)
Hide Description 20-items assessed quality of life in patients undergoing chemotherapy. Scores range from 1 (not at all/very poor) to 5 (very much/very well). Face scale scores (patient circles number of the face that best fits his/her feelings) range from 1 (sad face) to 5 (smiling face). Item scores were grouped according to Functional (daily activity: 5 items), Physical (5 items), Emotional (psychological condition: 4 items), Social Attitude (5 items), and Face Scale (1 item). Score of subscales were converted to scores with range from 0 to 100. Higher scores represent higher QOL.
Time Frame Baseline (pre-dose), 3 Months after first dose of Cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set: all randomized participants who met all of the inclusion criteria and none of the exclusion criteria and received at least one dose of study drug.
Arm/Group Title Pemetrexed 500 mg/m2 Pemetrexed 1000 mg/m2
Hide Arm/Group Description:
Pemetrexed 500 mg/m2, intravenous, every 21 days
Pemetrexed 1000 mg/m2, intravenous, every 21 days
Overall Number of Participants Analyzed 108 108
Mean (Standard Deviation)
Unit of Measure: units on a scale
Functional Baseline (n=107, n=107) 77.0  (24.81) 75.0  (26.18)
Functional Change from Baseline (n=58, n=60) -1.5  (23.66) -3.7  (19.99)
Physical Baseline (n=107, n=107) 78.9  (18.02) 73.9  (21.06)
Physical Change from Baseline (n=58, n=60) -1.6  (18.27) -3.5  (17.21)
Emotional Baseline (n=107, n=107) 67.2  (20.21) 62.1  (23.29)
Emotional Change from Baseline (n=58, n=60) -1.7  (17.36) 0.3  (20.10)
Sociality Baseline (n=107, n=107) 45.9  (22.09) 46.1  (22.37)
Sociality Change from Baseline (n=58, n=60) 1.6  (12.26) 1.6  (17.05)
Face Scale Baseline (n=107, n=107) 59.3  (20.75) 59.3  (25.12)
Face Scale Change from Baseline (n=58, n=60) -1.3  (20.64) -2.1  (21.73)
5.Secondary Outcome
Title Change From Baseline to 3 Months in Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) Lung Cancer Subscale (LCS)
Hide Description FACT-L LCS measured health-related quality of life (HR-QL) related to additional concerns of lung cancer. Original LCS subscale scores range from 0 to 28, but the scores were converted to scores with a range of 0 to 100 in this study. Higher scores represent better HR-QL.
Time Frame Baseline (pre-dose), 3 Months after first dose of Cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set: all randomized participants who met all of the inclusion criteria and none of the exclusion criteria and received at least one dose of study drug.
Arm/Group Title Pemetrexed 500 mg/m2 Pemetrexed 1000 mg/m2
Hide Arm/Group Description:
Pemetrexed 500 mg/m2, intravenous, every 21 days
Pemetrexed 1000 mg/m2, intravenous, every 21 days
Overall Number of Participants Analyzed 108 108
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=107, n=107) 71.5  (18.81) 69.6  (18.52)
Change from Baseline (n=58, n=60) 3.0  (16.13) 0.4  (18.63)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pemetrexed 500 mg/m2 Pemetrexed 1000 mg/m2
Hide Arm/Group Description Pemetrexed 500 mg/m2, intravenous, every 21 days Pemetrexed 1000 mg/m2, intravenous, every 21 days
All-Cause Mortality
Pemetrexed 500 mg/m2 Pemetrexed 1000 mg/m2
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Pemetrexed 500 mg/m2 Pemetrexed 1000 mg/m2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   19/114 (16.67%)      21/111 (18.92%)    
Blood and lymphatic system disorders     
Thrombocytopenia  1  1/114 (0.88%)  1 0/111 (0.00%)  0
Ear and labyrinth disorders     
Vertigo positional  1  1/114 (0.88%)  1 1/111 (0.90%)  1
Gastrointestinal disorders     
Diarrhoea  1  1/114 (0.88%)  1 1/111 (0.90%)  1
Gastric ulcer haemorrhage  1  0/114 (0.00%)  0 1/111 (0.90%)  1
Haematochezia  1  1/114 (0.88%)  1 0/111 (0.00%)  0
Ileus paralytic  1  0/114 (0.00%)  0 1/111 (0.90%)  1
Intestinal obstruction  1  1/114 (0.88%)  1 0/111 (0.00%)  0
Nausea  1  0/114 (0.00%)  0 1/111 (0.90%)  1
Vomiting  1  1/114 (0.88%)  1 1/111 (0.90%)  1
General disorders     
Malaise  1  1/114 (0.88%)  1 1/111 (0.90%)  1
Pyrexia  1  0/114 (0.00%)  0 5/111 (4.50%)  8
Immune system disorders     
Anaphylactic shock  1  0/114 (0.00%)  0 1/111 (0.90%)  1
Infections and infestations     
Cellulitis  1  0/114 (0.00%)  0 1/111 (0.90%)  1
Pneumonia  1  1/114 (0.88%)  1 2/111 (1.80%)  3
Pneumonia bacterial  1  1/114 (0.88%)  1 0/111 (0.00%)  0
Sepsis  1  0/114 (0.00%)  0 1/111 (0.90%)  1
Investigations     
C-reactive protein increased  1  0/114 (0.00%)  0 1/111 (0.90%)  1
Haemoglobin decreased  1  0/114 (0.00%)  0 2/111 (1.80%)  2
Oxygen saturation decreased  1  1/114 (0.88%)  1 0/111 (0.00%)  0
Metabolism and nutrition disorders     
Anorexia  1  0/114 (0.00%)  0 2/111 (1.80%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Cancer pain  1  2/114 (1.75%)  2 1/111 (0.90%)  1
Nervous system disorders     
Cerebral infarction  1  0/114 (0.00%)  0 1/111 (0.90%)  1
Depressed level of consciousness  1  1/114 (0.88%)  1 0/111 (0.00%)  0
Dizziness  1  1/114 (0.88%)  1 1/111 (0.90%)  1
Headache  1  1/114 (0.88%)  1 0/111 (0.00%)  0
Paralysis  1  1/114 (0.88%)  1 0/111 (0.00%)  0
Syncope  1  0/114 (0.00%)  0 1/111 (0.90%)  1
Vocal cord paralysis  1  1/114 (0.88%)  1 0/111 (0.00%)  0
Renal and urinary disorders     
Neurogenic bladder  1  1/114 (0.88%)  1 0/111 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Apnoea  1  1/114 (0.88%)  1 0/111 (0.00%)  0
Cough  1  0/114 (0.00%)  0 1/111 (0.90%)  1
Dyspnoea  1  0/114 (0.00%)  0 1/111 (0.90%)  1
Dyspnoea exertional  1  1/114 (0.88%)  1 0/111 (0.00%)  0
Haemoptysis  1  1/114 (0.88%)  1 0/111 (0.00%)  0
Interstitial lung disease  1  6/114 (5.26%)  6 3/111 (2.70%)  3
Skin and subcutaneous tissue disorders     
Rash  1  0/114 (0.00%)  0 2/111 (1.80%)  2
Vascular disorders     
Hypotension  1  0/114 (0.00%)  0 1/111 (0.90%)  1
Superior vena caval occlusion  1  1/114 (0.88%)  1 1/111 (0.90%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pemetrexed 500 mg/m2 Pemetrexed 1000 mg/m2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   114/114 (100.00%)      111/111 (100.00%)    
Gastrointestinal disorders     
Abdominal discomfort  1  6/114 (5.26%)  9 2/111 (1.80%)  2
Abdominal pain  1  5/114 (4.39%)  5 10/111 (9.01%)  12
Constipation  1  28/114 (24.56%)  33 21/111 (18.92%)  31
Diarrhoea  1  16/114 (14.04%)  23 15/111 (13.51%)  19
Nausea  1  64/114 (56.14%)  187 64/111 (57.66%)  133
Stomatitis  1  9/114 (7.89%)  12 13/111 (11.71%)  23
Vomiting  1  33/114 (28.95%)  122 36/111 (32.43%)  54
General disorders     
Chest pain  1  6/114 (5.26%)  7 3/111 (2.70%)  10
Face oedema  1  6/114 (5.26%)  6 4/111 (3.60%)  5
Fatigue  1  18/114 (15.79%)  35 18/111 (16.22%)  25
Feeling hot  1  9/114 (7.89%)  13 12/111 (10.81%)  16
Malaise  1  46/114 (40.35%)  100 49/111 (44.14%)  92
Oedema  1  6/114 (5.26%)  11 10/111 (9.01%)  11
Oedema peripheral  1  7/114 (6.14%)  8 6/111 (5.41%)  7
Pyrexia  1  35/114 (30.70%)  62 49/111 (44.14%)  97
Infections and infestations     
Nasopharyngitis  1  14/114 (12.28%)  18 14/111 (12.61%)  19
Investigations     
Alanine aminotransferase increased  1  81/114 (71.05%)  227 82/111 (73.87%)  185
Aspartate aminotransferase increased  1  88/114 (77.19%)  271 88/111 (79.28%)  254
Blood albumin decreased  1  25/114 (21.93%)  53 44/111 (39.64%)  85
Blood alkaline phosphatase increased  1  35/114 (30.70%)  51 35/111 (31.53%)  64
Blood bilirubin increased  1  11/114 (9.65%)  22 19/111 (17.12%)  43
Blood chloride decreased  1  7/114 (6.14%)  11 5/111 (4.50%)  10
Blood creatinine increased  1  11/114 (9.65%)  15 13/111 (11.71%)  25
Blood glucose increased  1  22/114 (19.30%)  36 19/111 (17.12%)  42
Blood lactate dehydrogenase increased  1  71/114 (62.28%)  182 71/111 (63.96%)  130
Blood potassium decreased  1  3/114 (2.63%)  7 6/111 (5.41%)  18
Blood potassium increased  1  4/114 (3.51%)  4 7/111 (6.31%)  15
Blood pressure increased  1  4/114 (3.51%)  8 8/111 (7.21%)  12
Blood sodium decreased  1  10/114 (8.77%)  11 10/111 (9.01%)  16
Blood urea increased  1  12/114 (10.53%)  18 9/111 (8.11%)  22
Blood urine present  1  20/114 (17.54%)  26 13/111 (11.71%)  27
C-reactive protein increased  1  31/114 (27.19%)  96 41/111 (36.94%)  102
Gamma-glutamyltransferase increased  1  10/114 (8.77%)  11 11/111 (9.91%)  16
Glucose urine present  1  11/114 (9.65%)  20 8/111 (7.21%)  21
Haemoglobin decreased  1  59/114 (51.75%)  133 68/111 (61.26%)  152
Lymphocyte count decreased  1  56/114 (49.12%)  109 64/111 (57.66%)  163
Neutrophil count decreased  1  73/114 (64.04%)  280 74/111 (66.67%)  256
Neutrophil count increased  1  22/114 (19.30%)  38 37/111 (33.33%)  84
Platelet count decreased  1  54/114 (47.37%)  170 51/111 (45.95%)  145
Platelet count increased  1  15/114 (13.16%)  52 12/111 (10.81%)  43
Protein total decreased  1  12/114 (10.53%)  22 20/111 (18.02%)  28
Protein urine present  1  18/114 (15.79%)  27 16/111 (14.41%)  27
Red blood cell count decreased  1  46/114 (40.35%)  109 45/111 (40.54%)  82
Urobilin urine present  1  5/114 (4.39%)  5 6/111 (5.41%)  9
Weight decreased  1  20/114 (17.54%)  20 30/111 (27.03%)  34
White blood cell count decreased  1  80/114 (70.18%)  287 81/111 (72.97%)  274
White blood cell count increased  1  27/114 (23.68%)  49 37/111 (33.33%)  83
Metabolism and nutrition disorders     
Anorexia  1  56/114 (49.12%)  149 76/111 (68.47%)  157
Decreased appetite  1  7/114 (6.14%)  8 10/111 (9.01%)  19
Musculoskeletal and connective tissue disorders     
Arthralgia  1  8/114 (7.02%)  17 5/111 (4.50%)  5
Back pain  1  9/114 (7.89%)  10 7/111 (6.31%)  13
Myalgia  1  6/114 (5.26%)  6 1/111 (0.90%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Cancer pain  1  20/114 (17.54%)  24 15/111 (13.51%)  15
Tumour associated fever  1  5/114 (4.39%)  11 11/111 (9.91%)  24
Nervous system disorders     
Dizziness  1  8/114 (7.02%)  12 8/111 (7.21%)  9
Dysgeusia  1  4/114 (3.51%)  7 7/111 (6.31%)  12
Headache  1  16/114 (14.04%)  24 18/111 (16.22%)  29
Hypoaesthesia  1  8/114 (7.02%)  8 5/111 (4.50%)  6
Psychiatric disorders     
Insomnia  1  12/114 (10.53%)  13 12/111 (10.81%)  13
Respiratory, thoracic and mediastinal disorders     
Cough  1  28/114 (24.56%)  31 16/111 (14.41%)  16
Dyspnoea  1  12/114 (10.53%)  13 13/111 (11.71%)  14
Epistaxis  1  2/114 (1.75%)  4 7/111 (6.31%)  9
Haemoptysis  1  10/114 (8.77%)  12 7/111 (6.31%)  8
Hiccups  1  4/114 (3.51%)  8 8/111 (7.21%)  10
Hypoxia  1  6/114 (5.26%)  6 8/111 (7.21%)  10
Oropharyngeal pain  1  8/114 (7.02%)  9 8/111 (7.21%)  13
Productive cough  1  11/114 (9.65%)  13 8/111 (7.21%)  8
Rhinorrhoea  1  9/114 (7.89%)  9 9/111 (8.11%)  13
Skin and subcutaneous tissue disorders     
Pigmentation disorder  1  8/114 (7.02%)  8 4/111 (3.60%)  4
Pruritus  1  14/114 (12.28%)  19 13/111 (11.71%)  25
Rash  1  79/114 (69.30%)  128 87/111 (78.38%)  134
Vascular disorders     
Hot flush  1  5/114 (4.39%)  6 7/111 (6.31%)  10
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
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
ClinicalTrials.gov Identifier: NCT00191191    
Other Study ID Numbers: 5250
H3E-JE-NS01 ( Other Identifier: Eli Lilly and Company )
First Submitted: September 12, 2005
First Posted: September 19, 2005
Results First Submitted: October 23, 2009
Results First Posted: November 25, 2009
Last Update Posted: December 9, 2009