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Chemotherapy for Patients With Non-Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT00380718
Recruitment Status : Completed
First Posted : September 26, 2006
Results First Posted : October 6, 2009
Last Update Posted : November 16, 2010
Sponsor:
Information provided by:
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Non-small Cell Lung Cancer
Intervention Drug: pemetrexed
Enrollment 33
Recruitment Details  
Pre-assignment Details Thirty-seven participants were screened; 3 did not meet inclusion/exclusion criteria and one withdrew.
Arm/Group Title Pemetrexed
Hide Arm/Group Description 500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days until disease progression (toxicity in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 in subsequent cycles).
Period Title: Overall Study
Started 33
Received at Least One Dose of Study Drug 33
Received Escalated Dose in Cycle 2 25
Completed 15
Not Completed 18
Reason Not Completed
Adverse Event             1
Death after 30-day post-therapy followup             17
Arm/Group Title Pemetrexed
Hide Arm/Group Description 500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days until disease progression (toxicity in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 in subsequent cycles).
Overall Number of Baseline Participants 33
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 33 participants
58.0  (11.27)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants
Female
13
  39.4%
Male
20
  60.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Taiwan Number Analyzed 33 participants
33
Disease Characteristic: Basis for Diagnosis  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 33 participants
Histopathological 17
Cytological 16
Disease Characteristic: Disease Stage at Study Entry   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 33 participants
Stage IIIB 3
Stage IV 30
[1]
Measure Description: Stage means how big the tumor is and how far it's spread. Stages range from 0 (the cancer has not spread beyond the inner lining of the lung) to IV (the cancer has spread to other organs of the body such as the other lung, brain, or liver).
Disease Characteristic: Eastern Cooperative Oncology Group Performance Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 33 participants
0 - Fully Active 9
1 - Ambulatory, Restricted Strenuous Activity 24
[1]
Measure Description: Classifies patients according to their functional impairment. Scores range from 0 (Fully Active) to 5 (Death).
Disease Characterstic: Pathological Diagnosis Code  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 33 participants
Adenocarcinoma of Lung 23
Large Cell Carcinoma of Lung 1
Mixed Cell 0
Squamous Cell Carcinoma of Lung 8
Non-Small Cell Lung Carcinoma 1
Race/Ethnicity  
Measure Type: Number
Unit of measure:  Participants
East/Southeast Asian Number Analyzed 33 participants
33
Smoking Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 33 participants
Ever Smoking 20
Never Smoking 13
24 Hour Creatinine Clearance   [1] 
Mean (Standard Deviation)
Unit of measure:  Milliliters per minute (ml/min)
Number Analyzed 33 participants
81.142  (24.9265)
[1]
Measure Description: N=32 (Data not available for 1 participant).
Body Temperature  
Mean (Standard Deviation)
Unit of measure:  Degrees Celcius (°C)
Number Analyzed 33 participants
36.25  (0.336)
Disease Characteristic: Time from Initial Diagnosis to Prior Chemotherapy Failure   [1] 
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 33 participants
12.04  (23.764)
[1]
Measure Description: N=25 (Data not available for 8 patients)
Disease Characteristic: Time from Initial Diagnosis to Study Entry  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 33 participants
11.54  (20.829)
Disease Characteristic: Time from Prior Chemotherapy Failure to Study Entry   [1] 
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 33 participants
1.00  (0.486)
[1]
Measure Description: N=25 (Data not available for 8 patients)
Heart Rate  
Mean (Standard Deviation)
Unit of measure:  Beats per minute (bpm)
Number Analyzed 33 participants
87.5  (15.00)
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeters
Number Analyzed 33 participants
162.0  (8.59)
Homocysteine  
Mean (Standard Deviation)
Unit of measure:  Micromoles per Liter (μmol/L)
Number Analyzed 33 participants
7.521  (2.6229)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 33 participants
63.08  (9.912)
1.Primary Outcome
Title Proportion of Participants With a Complete or Partial Response (Objective Response Rate [ORR])
Hide Description The objective response rate (ORR) was defined as the proportion of participants who achieved a best response of either complete response (CR) or partial response (PR) (responders) based on the RECIST criteria. ORR=(CR+PR)/Number of Participants. The RECIST define when cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments.
Time Frame baseline to measured progressive disease (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until documented disease progression, or up to 18 months after enrollment)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants who received at least one dose of study drug. Participants who were classified as "Unknown" were considered nonresponders rather than missing.
Arm/Group Title Pemetrexed
Hide Arm/Group Description:
500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days until disease progression (toxicity in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 in subsequent cycles).
Overall Number of Participants Analyzed 33
Mean (95% Confidence Interval)
Unit of Measure: proportion of responders
0.182
(0.07 to 0.355)
2.Secondary Outcome
Title Proportion of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), and Stable Disease (SD) (Disease Control Rate [DCR])
Hide Description DCR was defined as the proportion of best overall response of CR, PR, and SD. DCR=(CR+PR+SD)/Number of participants. Response was evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease 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 (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until documented disease progression, or up to 18 months after enrollment)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants who received at least one dose of study drug. Participants who were classified as "Unknown" were considered nonresponders rather than missing.
Arm/Group Title Pemetrexed
Hide Arm/Group Description:
500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days until disease progression (toxicity in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 in subsequent cycles).
Overall Number of Participants Analyzed 33
Mean (95% Confidence Interval)
Unit of Measure: proportion of participants
0.545
(0.364 to 0.719)
3.Secondary Outcome
Title Overall Survival
Hide Description Overall survival is the duration from enrollment to death from any cause. For patients who are alive, overall survival is censored at the last follow-up visit.
Time Frame baseline to date of death from any cause (includes post-treatment follow-up of up to 18 months post-Last Patient Entered Treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants who received at least one dose of study drug. Sixteen participants were censored as they were alive at the time of analysis.
Arm/Group Title Pemetrexed
Hide Arm/Group Description:
500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days until disease progression (toxicity in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 in subsequent cycles).
Overall Number of Participants Analyzed 33
Median (Full Range)
Unit of Measure: months
20.2
(0.7 to 32.0)
4.Secondary Outcome
Title Progression-Free Survival (PFS)
Hide Description Time to PFS was defined as the time from the date of enrollment to the date of the first of the following events: objective disease progression or death due to any cause. Survival time frame includes post-treatment follow-up of up to 18 months post-Last Patient Entered Treatment. Patients were censored if their disease had not progressed, treatment was discontinued due to an undocumented progression or toxicity/other reason, onset of new anti-tumor therapy or otherwise experienced death/progression after more than one missed (assessment) visit.
Time Frame baseline to measured progressive disease or death from any cause (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until documented disease progression, or up to 18 months after enrollment)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants who received at least one dose of study drug. Sixteen participants were censored as they were alive at the time of analysis.
Arm/Group Title Pemetrexed
Hide Arm/Group Description:
500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days until disease progression (toxicity in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 in subsequent cycles).
Overall Number of Participants Analyzed 33
Median (95% Confidence Interval)
Unit of Measure: months
6.9
(3.0 to 9.5)
5.Secondary Outcome
Title Duration of Response
Hide Description Duration of overall tumor response was measured from the time of first documentation of complete response or partial response (whichever status was first recorded) until the date of progression-free survival, with censoring defined as: disease had not progressed, treatment was discontinued due to undocumented progression or toxicity/other reason, onset of new anti-tumor therapy or otherwise experienced death/progression after more than one missed (assessment) visit.
Time Frame time of response to measured progressive disease or death from any cause (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until documented disease progression, or up to 18 months after enrollment)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received study drug and who had either a complete or partial response to treatment. Three participants were censored as they were alive at the time of analysis.
Arm/Group Title Pemetrexed
Hide Arm/Group Description:
500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days until disease progression (toxicity in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 in subsequent cycles).
Overall Number of Participants Analyzed 6
Median (Full Range)
Unit of Measure: months
6.6
(1.6 to 9.7)
6.Secondary Outcome
Title Time to Treatment Failure
Hide Description Time to treatment failure was define as the time from the date of enrollment to the date of the first of the following events: objective disease progression, death due to any cause, treatment discontinuation for undocumented progression, early treatment discontinuation for toxicity or other reason, or new anticancer treatment started. Time to treatment failure for participants who were still participating in the study without treatment failure at the time of analysis were treated as censored at the date of the last tumor assessment.
Time Frame baseline to early treatment discontinuation or measured progressive disease or death from any cause (assessments every 2 cycles during therapy and 6-8 weeks during post-therapy until documented disease progression, or up to 18 months after enrollment)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants who received at least one dose of study drug. One patient was censored as he/she was alive at time of analysis.
Arm/Group Title Pemetrexed
Hide Arm/Group Description:
500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days until disease progression (toxicity in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 in subsequent cycles).
Overall Number of Participants Analyzed 33
Median (95% Confidence Interval)
Unit of Measure: months
2.9
(1.7 to 4.9)
7.Secondary Outcome
Title Time to Tumor Progression
Hide Description Time to documented tumor progression was defined as the time from the date of enrollment to the first date of documented disease progression. Time to documented disease progression was censored at the date of death for participants who had not had documented disease progression. Otherwise, the censoring rules were the same as for Progression-Free Survival.
Time Frame baseline to measured progressive disease (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until documented disease progression, or up to 18 months after enrollment)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants who received at least one dose of study drug. Sixteen participants were censored as they were alive at the time of analysis.
Arm/Group Title Pemetrexed
Hide Arm/Group Description:
500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days until disease progression (toxicity in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 in subsequent cycles).
Overall Number of Participants Analyzed 33
Median (95% Confidence Interval)
Unit of Measure: months
6.9
(3.0 to 9.5)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pemetrexed
Hide Arm/Group Description 500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days until disease progression (toxicity in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 in subsequent cycles).
All-Cause Mortality
Pemetrexed
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Pemetrexed
Affected / at Risk (%) # Events
Total   13/33 (39.39%)    
Blood and lymphatic system disorders   
Anaemia  1  1/33 (3.03%)  1
Leukopenia  1  1/33 (3.03%)  1
Neutropenia  1  1/33 (3.03%)  1
Cardiac disorders   
Cardiac tamponade  1  1/33 (3.03%)  1
Pericardial effusion  1  1/33 (3.03%)  1
General disorders   
Pyrexia  1  1/33 (3.03%)  1
Infections and infestations   
Cellulitis  1  1/33 (3.03%)  1
Infection  1  1/33 (3.03%)  1
Sepsis  1  1/33 (3.03%)  1
Metabolism and nutrition disorders   
Diabetes mellitus  1  1/33 (3.03%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Metastases to bone  1  1/33 (3.03%)  1
Respiratory, thoracic and mediastinal disorders   
Chronic obstructive pulmonary disease  1  1/33 (3.03%)  1
Haemoptysis  1  1/33 (3.03%)  1
Pneumonitis  1  2/33 (6.06%)  2
Skin and subcutaneous tissue disorders   
Stasis dermatitis  1  1/33 (3.03%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pemetrexed
Affected / at Risk (%) # Events
Total   33/33 (100.00%)    
Blood and lymphatic system disorders   
Anaemia  1  7/33 (21.21%)  11
Leukopenia  1  7/33 (21.21%)  25
Neutropenia  1  5/33 (15.15%)  10
Thrombocytopenia  1  4/33 (12.12%)  5
Ear and labyrinth disorders   
Vertigo  1  2/33 (6.06%)  2
Eye disorders   
Cataract  1  2/33 (6.06%)  2
Conjunctivitis  1  2/33 (6.06%)  2
Gastrointestinal disorders   
Abdominal distension  1  5/33 (15.15%)  5
Abdominal pain  1  2/33 (6.06%)  2
Abdominal pain upper  1  7/33 (21.21%)  10
Constipation  1  5/33 (15.15%)  6
Diarrhoea  1  3/33 (9.09%)  3
Dry mouth  1  2/33 (6.06%)  2
Mouth ulceration  1  2/33 (6.06%)  3
Nausea  1  8/33 (24.24%)  12
Vomiting  1  9/33 (27.27%)  12
General disorders   
Asthenia  1  3/33 (9.09%)  3
Chest pain  1  9/33 (27.27%)  10
Fatigue  1  11/33 (33.33%)  28
Malaise  1  6/33 (18.18%)  10
Pyrexia  1  8/33 (24.24%)  9
Infections and infestations   
Herpes virus infection  1  2/33 (6.06%)  2
Pneumonia  1  2/33 (6.06%)  2
Investigations   
Alanine aminotransferase increased  1  10/33 (30.30%)  10
Aspartate aminotransferase increased  1  8/33 (24.24%)  8
Blood alkaline phosphatase increased  1  4/33 (12.12%)  4
Creatinine renal clearance decreased  1  2/33 (6.06%)  2
Haemoglobin decreased  1  6/33 (18.18%)  8
Lymphocyte count decreased  1  5/33 (15.15%)  17
Lymphocyte percentage decreased  1  2/33 (6.06%)  4
Neutrophil count decreased  1  8/33 (24.24%)  22
White blood cell count decreased  1  7/33 (21.21%)  20
Metabolism and nutrition disorders   
Anorexia  1  9/33 (27.27%)  11
Decreased appetite  1  7/33 (21.21%)  7
Hypokalaemia  1  2/33 (6.06%)  2
Musculoskeletal and connective tissue disorders   
Back pain  1  4/33 (12.12%)  5
Bone pain  1  4/33 (12.12%)  4
Pain in extremity  1  2/33 (6.06%)  2
Nervous system disorders   
Dizziness  1  3/33 (9.09%)  3
Headache  1  2/33 (6.06%)  2
Hypoaesthesia  1  4/33 (12.12%)  7
Psychiatric disorders   
Insomnia  1  3/33 (9.09%)  3
Respiratory, thoracic and mediastinal disorders   
Cough  1  10/33 (30.30%)  12
Dyspnoea  1  7/33 (21.21%)  8
Haemoptysis  1  3/33 (9.09%)  6
Oropharyngeal pain  1  6/33 (18.18%)  9
Rhinorrhoea  1  9/33 (27.27%)  9
Sneezing  1  2/33 (6.06%)  2
Skin and subcutaneous tissue disorders   
Pruritus  1  11/33 (33.33%)  17
Rash  1  7/33 (21.21%)  9
Skin hyperpigmentation  1  6/33 (18.18%)  6
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
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: NCT00380718     History of Changes
Other Study ID Numbers: 10720
H3E-MC-JMIC ( Other Identifier: Eli Lilly and Company )
First Submitted: September 22, 2006
First Posted: September 26, 2006
Results First Submitted: September 2, 2009
Results First Posted: October 6, 2009
Last Update Posted: November 16, 2010