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Erlotinib Versus Pemetrexed as Second-Line Therapy in Treating Patients With Advanced Lung Adenocarcinoma

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ClinicalTrials.gov Identifier: NCT01565538
Recruitment Status : Completed
First Posted : March 28, 2012
Results First Posted : September 15, 2014
Last Update Posted : September 15, 2014
Sponsor:
Information provided by (Responsible Party):
Si-Yu Wang, Sun Yat-sen University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lung Cancer
Interventions Drug: Erlotinib
Drug: Pemetrexed
Enrollment 123
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Erlotinib Pemetrexed
Hide Arm/Group Description

Erlotinib at the dose of 150 mg orally once a day continually until progression.

Erlotinib: 150 mg Given orally

Pemetrexed at the dose of 500mg/m2 IV infusion every 3 weeks until progression.

Pemetrexed: 500mg/m2 Given IV

Period Title: Overall Study
Started 61 62
Completed 61 62
Not Completed 0 0
Arm/Group Title Erlotinib Pemetrexed Total
Hide Arm/Group Description

Erlotinib at the dose of 150 mg orally once a day continually until progression.

Erlotinib: 150 mg Given orally

Pemetrexed at the dose of 500mg/m2 IV infusion every 3 weeks until progression.

Pemetrexed: 500mg/m2 Given IV

Total of all reporting groups
Overall Number of Baseline Participants 61 62 123
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 61 participants 62 participants 123 participants
54.3
(30 to 74)
55.1
(33 to 75)
54.7
(30 to 75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 62 participants 123 participants
Female
21
  34.4%
23
  37.1%
44
  35.8%
Male
40
  65.6%
39
  62.9%
79
  64.2%
ECOG PS   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 61 participants 62 participants 123 participants
0,1 57 59 116
2 4 3 7
[1]
Measure Description: Eastern Cooperative Oncology Group performance status. ECOG 0=Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; 2 = Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours.
Smoking status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 61 participants 62 participants 123 participants
Never 15 17 32
Former 7 5 12
Current 39 40 79
Stage   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 61 participants 62 participants 123 participants
IIIB 4 6 10
IV 40 38 78
Recurrent 17 18 35
[1]
Measure Description: Tumors were classified according to the 1997 International System for Staging Lung Cancer. Reference: Mountain CF. Revisions in the International System for Staging Lung Cancer.Chest.1997;111:1710-1717.
1.Primary Outcome
Title Progression-Free Survival
Hide Description Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time Frame From the date of randomization to the date of tumour progression or death from any cause, assessed until at least 12 months after randomization.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Erlotinib Pemetrexed
Hide Arm/Group Description:

Erlotinib at the dose of 150 mg orally once a day continually until progression.

Erlotinib: 150 mg Given orally

Pemetrexed at the dose of 500mg/m2 IV infusion every 3 weeks until progression.

Pemetrexed: 500mg/m2 Given IV

Overall Number of Participants Analyzed 61 62
Median (95% Confidence Interval)
Unit of Measure: months
4.1
(1.6 to 6.6)
3.9
(2.7 to 5.1)
2.Secondary Outcome
Title Best Tumor Response
Hide Description Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time Frame From the date of randomization, assessed every 6 weeks, until at least 12 months after randomization.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Erlotinib Pemetrexed
Hide Arm/Group Description:

Erlotinib at the dose of 150 mg orally once a day continually until progression.

Erlotinib: 150 mg Given orally

Pemetrexed at the dose of 500mg/m2 IV infusion every 3 weeks until progression.

Pemetrexed: 500mg/m2 Given IV

Overall Number of Participants Analyzed 61 62
Measure Type: Number
Unit of Measure: participants
Objective response 12 5
No objective response 49 57
3.Secondary Outcome
Title Overall Survival
Hide Description [Not Specified]
Time Frame From date of randomization until the date of death from any cause, assessed until at least 12 months after randomization.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Erlotinib Pemetrexed
Hide Arm/Group Description:

Erlotinib at the dose of 150 mg orally once a day continually until progression.

Erlotinib: 150 mg Given orally

Pemetrexed at the dose of 500mg/m2 IV infusion every 3 weeks until progression.

Pemetrexed: 500mg/m2 Given IV

Overall Number of Participants Analyzed 61 62
Median (95% Confidence Interval)
Unit of Measure: months
11.7
(7.5 to 15.9)
13.4
(9.2 to 17.7)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Erlotinib Pemetrexed
Hide Arm/Group Description

Erlotinib at the dose of 150 mg orally once a day continually until progression.

Erlotinib: 150 mg Given orally

Pemetrexed at the dose of 500mg/m2 IV infusion every 3 weeks until progression.

Pemetrexed: 500mg/m2 Given IV

All-Cause Mortality
Erlotinib Pemetrexed
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Erlotinib Pemetrexed
Affected / at Risk (%) Affected / at Risk (%)
Total   0/61 (0.00%)   0/62 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Erlotinib Pemetrexed
Affected / at Risk (%) Affected / at Risk (%)
Total   45/61 (73.77%)   43/62 (69.35%) 
Blood and lymphatic system disorders     
Leukopenia   0/61 (0.00%)  3/62 (4.84%) 
Gastrointestinal disorders     
Diarrhea   10/61 (16.39%)  2/62 (3.23%) 
Anorexia   6/61 (9.84%)  9/62 (14.52%) 
Nausea   1/61 (1.64%)  15/62 (24.19%) 
Constipation   0/61 (0.00%)  4/62 (6.45%) 
General disorders     
Fatigue   12/61 (19.67%)  16/62 (25.81%) 
Infections and infestations     
Infection   3/61 (4.92%)  1/62 (1.61%) 
Nervous system disorders     
Headache   1/61 (1.64%)  3/62 (4.84%) 
Psychiatric disorders     
Insomnia   4/61 (6.56%)  3/62 (4.84%) 
Skin and subcutaneous tissue disorders     
Rash   33/61 (54.10%)  4/62 (6.45%) 
Dry skin   3/61 (4.92%)  0/62 (0.00%) 
Pruritus   3/61 (4.92%)  0/62 (0.00%) 
Alopecia   0/61 (0.00%)  3/62 (4.84%) 
Paronychia   1/61 (1.64%)  0/62 (0.00%) 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Si-Yu Wang
Organization: Sun Yat-sen University Cancer Center
Phone: 020-87343439
EMail: wsysums@163.net
Layout table for additonal information
Responsible Party: Si-Yu Wang, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01565538    
Other Study ID Numbers: wsy001
First Submitted: March 22, 2012
First Posted: March 28, 2012
Results First Submitted: September 3, 2014
Results First Posted: September 15, 2014
Last Update Posted: September 15, 2014