Trial record 1 of 1 for:    N0723
Previous Study | Return to List | Next Study

Pemetrexed Disodium or Erlotinib Hydrochloride as Second-Line Therapy in Treating Patients With Advanced Non-Small Cell Lung Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Southwest Oncology Group
Cancer and Leukemia Group B
Eastern Cooperative Oncology Group
NCIC Clinical Trials Group
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00738881
First received: August 20, 2008
Last updated: September 26, 2014
Last verified: December 2013
Results First Received: November 27, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Recurrent Non-small Cell Lung Cancer
Stage IIIA Non-small Cell Lung Cancer
Stage IIIB Non-small Cell Lung Cancer
Stage IV Non-small Cell Lung Cancer
Interventions: Drug: erlotinib hydrochloride
Drug: pemetrexed disodium

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Twenty nine (29) pre-registered, screen failures (4 inadequate tissue, 1 investigator decision and one patient decision). Twenty three (23) patients were randomized, 2 patients withdrew from study prior to receiving any study treatment, thus a total of 23 randomized patients are evaluable for the primary and secondary endpoints.

Reporting Groups
  Description
Arm I

Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

erlotinib hydrochloride: Given orally

Arm II

Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

pemetrexed disodium: Given IV


Participant Flow:   Overall Study
    Arm I     Arm II  
STARTED     11     12  
COMPLETED     11     10  
NOT COMPLETED     0     2  
Withdrawal by Subject                 0                 2  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Arm I

Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

erlotinib hydrochloride: Given orally

Arm II

Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

pemetrexed disodium: Given IV

Total Total of all reporting groups

Baseline Measures
    Arm I     Arm II     Total  
Number of Participants  
[units: participants]
  11     12     23  
Age  
[units: years]
Median ( Full Range )
  69  
  ( 51 to 76 )  
  55  
  ( 49 to 75 )  
  62  
  ( 49 to 76 )  
Gender  
[units: participants]
     
Female     6     6     12  
Male     5     6     11  
Region of Enrollment  
[units: participants]
     
United States     11     12     23  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression-free Survival (PFS)   [ Time Frame: Time from randomization to the first date of documented disease progression or death, assessed up to 5 years ]

2.  Secondary:   Time to Treatment Failure   [ Time Frame: The time from date of randomization to the date at which the patient is removed from the treatment, assessed up to 5 years ]

3.  Secondary:   Overall Survival   [ Time Frame: Time from randomization to time of death from any cause, assessed up to 5 years ]

4.  Secondary:   Confirmed Response Rate Defined as Complete Response (CR) or a Partial Response (PR) Per Response Evaluation Criteria In Solid Tumors (RECIST)   [ Time Frame: Up to 5 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Alex A. Adjei, M.D., Ph.D
Organization: Roswell Park Cancer Institute
phone: 507/538-1760
e-mail: alex.adjei@roswellpark.org


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00738881     History of Changes
Other Study ID Numbers: NCI-2009-00663, NCI-2009-00663, CDR0000612010, NCCTG-N0723, CALGB-30802, CAN-NCIC-BRC4, N0723, N0723, U10CA025224
Study First Received: August 20, 2008
Results First Received: November 27, 2013
Last Updated: September 26, 2014
Health Authority: United States: Food and Drug Administration