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Pemetrexed and Cisplatin Treatment Before Surgery in Non Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT00259285
Recruitment Status : Terminated (Trial was stopped early due to low enrollment.)
First Posted : November 29, 2005
Results First Posted : June 2, 2009
Last Update Posted : June 2, 2009
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
Interventions Drug: pemetrexed
Drug: cisplatin
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pemetrexed + Cisplatin
Hide Arm/Group Description Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 3 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 3 cycles
Period Title: Overall Study
Started 10
Completed 10
Not Completed 0
Arm/Group Title Pemetrexed + Cisplatin
Hide Arm/Group Description Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 3 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 3 cycles
Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants
61.6  (8.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
4
  40.0%
Male
6
  60.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Spain Number Analyzed 10 participants
10
Eastern Cooperative Oncology Group Functional Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 10 participants
0 - Fully Active 8
1 - Ambulatory, Restricted Strenuous Activity 2
2 - Ambulatory, No Work Activities 0
3 - Partially Confined to Bed, Limited Self Care 0
4 - Completely Disabled 0
Race/Ethnicity  
Measure Type: Number
Unit of measure:  Participants
Caucasian Number Analyzed 10 participants
10
Body Mass Index   [1] 
Mean (Standard Deviation)
Unit of measure:  Kilograms per square meters
Number Analyzed 10 participants
27.1  (4.3)
[1]
Measure Description: weight divided by square height
Corporal Surface (Body Surface Area)   [1] 
Mean (Standard Deviation)
Unit of measure:  Square meters
Number Analyzed 10 participants
1.8  (0.2)
[1]
Measure Description: The total surface area of the body (BSA). BSA was calculated by taking the square root of product of the weight in kilograms times the height in centimeters divided by 3600.
Height  
Mean (Standard Deviation)
Unit of measure:  Meters
Number Analyzed 10 participants
1.6  (0.1)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 10 participants
72.8  (12.2)
1.Primary Outcome
Title Treatment Response
Hide Description Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment.
Time Frame every 21 day cycle (3 cycles) and 3-4 weeks after last cycle
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pemetrexed + Cisplatin
Hide Arm/Group Description:
Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 3 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 3 cycles
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: participants
Complete Response 0
Partial Response 5
Incomplete Response/Stable Disease 4
Progressive Disease 1
Not Evaluable 0
2.Secondary Outcome
Title Pathologic Remissions After Surgery
Hide Description The status of the pathological response was evaluated on the basis of the original results of the histopathological examination of the tumour samples resected. A complete pathological response was defined as the absence of any viable tumour cell in the tumour samples obtained for histological examination.
Time Frame surgical tumor resection (3-4 weeks after completing three 21-day cycles of therapy)
Hide Outcome Measure Data
Hide Analysis Population Description
7 out of the 10 patients had surgery.
Arm/Group Title Pemetrexed + Cisplatin
Hide Arm/Group Description:
Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 3 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 3 cycles
Overall Number of Participants Analyzed 7
Measure Type: Number
Unit of Measure: participants
Complete Remission - Yes 5
Complete Remission - No 2
3.Secondary Outcome
Title Relapse-free Survival
Hide Description Results for this outcome measure were not analyzed because the trial stopped early due to low enrollment.
Time Frame Every 21 day cycle (3 cycles) and then every 3 months for the first 2 years, every 6 months until 5 years have elapsed and annually thereafter
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pemetrexed + Cisplatin
Hide Arm/Group Description:
Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 3 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 3 cycles
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pemetrexed + Cisplatin
Hide Arm/Group Description Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 3 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 3 cycles
All-Cause Mortality
Pemetrexed + Cisplatin
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Pemetrexed + Cisplatin
Affected / at Risk (%) # Events
Total   1    
Infections and infestations   
Urinary tract infection * 1  1/10 (10.00%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 10%
Pemetrexed + Cisplatin
Affected / at Risk (%) # Events
Total   8    
Blood and lymphatic system disorders   
Leukocytosis * 1  1/10 (10.00%)  1
Leukopenia * 1  1/10 (10.00%)  1
Neutrophilia * 1  1/10 (10.00%)  1
Gastrointestinal disorders   
Abdominal Distension * 1  1/10 (10.00%)  1
Constipation * 1  1/10 (10.00%)  1
Diarrhoea * 1  1/10 (10.00%)  1
Nausea * 1  4/10 (40.00%)  5
Vomiting * 1  2/10 (20.00%)  2
General disorders   
Fatigue * 1  1/10 (10.00%)  1
Mucosal inflammation * 1  1/10 (10.00%)  1
Pyrexia * 1  1/10 (10.00%)  2
Infections and infestations   
Candidiasis * 1  1/10 (10.00%)  1
Respiratory tract infection * 1  1/10 (10.00%)  1
Investigations   
Alanine aminotransferase increased * 1  2/10 (20.00%)  2
Aspartate aminotransferase increased * 2  2/10 (20.00%)  2
Haemoglobin decreased * 1  1/10 (10.00%)  1
Platelet count increased * 1  1/10 (10.00%)  1
Metabolism and nutrition disorders   
Diabetes mellitus * 1  1/10 (10.00%)  1
Musculoskeletal and connective tissue disorders   
Musculoskeletal chest pain * 1  1/10 (10.00%)  1
Nervous system disorders   
Motor dysfunction * 1  1/10 (10.00%)  1
Paraesthesia * 1  1/10 (10.00%)  1
Respiratory, thoracic and mediastinal disorders   
Cough * 1  3/10 (30.00%)  3
Dysphonia * 1  1/10 (10.00%)  1
Productive cough * 1  1/10 (10.00%)  1
Rhinorrhoea * 1  1/10 (10.00%)  1
Skin and subcutaneous tissue disorders   
Rash * 1  2/10 (20.00%)  2
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11.0
2
Term from vocabulary, MedDRA 10.0
Trial was stopped early due to low enrollment and the relapse-free survival outcome measure was not analyzed.
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: 1-800-545-5979
Layout table for additonal information
Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00259285    
Other Study ID Numbers: 9901
H3E-XM-S092
First Submitted: November 28, 2005
First Posted: November 29, 2005
Results First Submitted: December 19, 2008
Results First Posted: June 2, 2009
Last Update Posted: June 2, 2009