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S0526: Pemetrexed Disodium in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

This study has been terminated.
(Closed due to poor accrual)
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00265785
First received: December 14, 2005
Last updated: October 3, 2012
Last verified: October 2012
Results First Received: July 12, 2012  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Lung Cancer
Intervention: Drug: pemetrexed

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Pemetrexed Pemetrexed Disodium 500 mg/m^2 intravenous (IV) over 10 min every 21 days until any of the following criteria is met: (1) Progression of disease or symptomatic deterioration; (2) Unacceptable toxicity; (3) Treatment delay ≥ 3 weeks, for any reason; (4) The patient may withdraw from the study at any time for any reason; (5) Physician's discretion.

Participant Flow:   Overall Study
    Pemetrexed
STARTED   27 
Eligible   26 
Eligible and Began Protocol Treatment   24 
COMPLETED   0 
NOT COMPLETED   27 
Adverse Event                4 
Withdrawal by Subject                3 
Progression/Relapse                15 
Not protocol specified                2 
Ineligible                1 
Did not receive protocol treatment                2 



  Baseline Characteristics
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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
Pemetrexed Pemetrexed Disodium 500 mg/m^2 intravenous (IV) over 10 min every 21 days until any of the following criteria is met: (1) Progression of disease or symptomatic deterioration; (2) Unacceptable toxicity; (3) Treatment delay ≥ 3 weeks, for any reason; (4) The patient may withdraw from the study at any time for any reason; (5) Physician's discretion.

Baseline Measures
   Pemetrexed 
Overall Participants Analyzed 
[Units: Participants]
 24 
Age 
[Units: Years]
Median (Full Range)
 68.2 
 (49.6 to 82.9) 
Gender 
[Units: Participants]
 
Female   12 
Male   12 
Ethnicity (NIH/OMB) 
[Units: Participants]
 
Hispanic or Latino   1 
Not Hispanic or Latino   22 
Unknown or Not Reported   1 
Race (NIH/OMB) 
[Units: Participants]
 
American Indian or Alaska Native   0 
Asian   2 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   3 
White   17 
More than one race   1 
Unknown or Not Reported   1 
Histology 
[Units: Participants]
 
Adenocarcinoma w/BAC features   18 
Bronchioloalveolar   6 
Number of Metastatic Sites 
[Units: Participants]
 
Single   12 
Multiple   7 
None   5 
Stage 
[Units: Participants]
 
IIIB   0 
IV   24 
Prior EGFR-TKI Therapy 
[Units: Participants]
 
No   19 
Yes   5 
Prior Radiation Therapy 
[Units: Participants]
 
Yes   3 
No   21 
Prior Systemic Treatment 
[Units: Participants]
 
Yes   10 
No   14 
Prior Surgery 
[Units: Participants]
 
Yes   11 
No   13 
Zubbrod Performance Status [1] 
[Units: Participants]
 
 12 
 12 
[1] Performance status is graded according to the Zubrod Performance Status Scale. Patients with a performance status of 0 are fully active, able to carry on all pre-disease performance without restriction. Patients with a performance status of 1 are restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light housework, office work.
Smoking Status 
[Units: Participants]
 
Current   5 
Former   16 
Never   3 
Weight Loss Last 6 months 
[Units: Participants]
 
< 5%   20 
5% to < 10%   3 
10% to 20%   1 
> 20%   0 


  Outcome Measures
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1.  Primary:   Overall Survival   [ Time Frame: 0 - 3 years ]

2.  Secondary:   Progression-free Survival   [ Time Frame: 0 - 3 years ]

3.  Secondary:   Response (Confirmed and Unconfirmed, Complete and Partial)   [ Time Frame: Assessed at weeks 7 and 13 while on treatment. After off treatment prior to disease progression, disease assessment takes place every 3 months for a maximum of 3 years. ]

4.  Secondary:   Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug   [ Time Frame: Patients were assessed for adverse events 4 weeks after starting treatment. Assessments for adverse events continued after every cycle of treatment (every 3 weeks) for the duration of protocol treatment. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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:  
Name/Title: Study Statistician
Organization: SWOG Statistical Center
phone: 206-667-4623



Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00265785     History of Changes
Other Study ID Numbers: CDR0000456424
U10CA032102 ( US NIH Grant/Contract Award Number )
S0526 ( Other Identifier: SWOG )
Study First Received: December 14, 2005
Results First Received: July 12, 2012
Last Updated: October 3, 2012
Health Authority: United States: Federal Government