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Temozolomide for Relapsed Sensitive or Refractory Small Cell Lung Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00740636
First Posted: August 25, 2008
Last Update Posted: August 1, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Schering-Plough
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
Results First Submitted: October 20, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Lung Cancer
Intervention: Drug: Temozolomide

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
200 mg/m2/Day for 5 Days (23 Days Off tx). 28 Day Cycles. 200 mg/m2/day for 5 days (23 days off treatment). 28 day cycles.
75 mg/m2/Day for 21 Days (7 Days Off tx). 28 Day Cycles. 75 mg/m2/day for 21 days (7 days off treatment). 28 day cycles.

Participant Flow:   Overall Study
    200 mg/m2/Day for 5 Days (23 Days Off tx). 28 Day Cycles.   75 mg/m2/Day for 21 Days (7 Days Off tx). 28 Day Cycles.
STARTED   25   67 
COMPLETED   23   63 
NOT COMPLETED   2   4 
Adverse Event                0                2 
Patient Ineligible                0                1 
Patient Not Treated                0                1 
Progressive Disease                1                0 
Death                1                0 



  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
200 mg/m2/Day for 5 Days (23 Days Off tx). 28 Day Cycles. 200 mg/m2/day for 5 days (23 days off treatment). 28 day cycles.
75 mg/m2/Day for 21 Days (7 Days Off tx). 28 Day Cycles. 75 mg/m2/day for 21 days (7 days off treatment). 28 day cycles.
Total Total of all reporting groups

Baseline Measures
   200 mg/m2/Day for 5 Days (23 Days Off tx). 28 Day Cycles.   75 mg/m2/Day for 21 Days (7 Days Off tx). 28 Day Cycles.   Total 
Overall Participants Analyzed 
[Units: Participants]
 25   67   92 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   14   22   36 
>=65 years   11   45   56 
Gender 
[Units: Participants]
     
Female   16   37   53 
Male   9   30   39 


  Outcome Measures

1.  Primary:   The Objective Overall Response   [ Time Frame: 2 years ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Maria C. Pietanza
Organization: Memorial Sloan Kettering Cancer Center
phone: 646-888-4203
e-mail: PietanzM@mskcc.org



Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00740636     History of Changes
Other Study ID Numbers: 08-065
First Submitted: August 22, 2008
First Posted: August 25, 2008
Results First Submitted: October 20, 2015
Results First Posted: February 1, 2016
Last Update Posted: August 1, 2016