Tirapazamine Combined With Chemo and RT in Limited-Stage Small Cell Lung Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00066742
First received: August 6, 2003
Last updated: April 29, 2014
Last verified: December 2012
Results First Received: June 14, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Limited Stage Small Cell Lung Cancer
Interventions: Drug: tirapazamine
Drug: cisplatin
Drug: etoposide
Radiation: radiation therapy
Other: laboratory biomarker analysis

  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
Between 9/2003 and 7/2006, 72 of planned 85 limited smal-cell lung cancer patients were enrolled by SWOG institutions. The study was closed early due to a report of excess toxicity for Tirapazamine in a head and neck cancer trial elsewhere.

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
Evaluable Patients Only eligible patients who received the study intervention were included in the analysis.

Participant Flow for 2 periods

Period 1:   Induction Chemoradiotherapy
    Evaluable Patients  
STARTED     72  
Eligible     69  
Began Protocol Treatment     68  
COMPLETED     43  
NOT COMPLETED     29  
Did not receive any protocol treatment                 1  
Adverse Event                 21  
Withdrawal by Subject                 2  
not protocol specified                 2  
Ineligible                 3  

Period 2:   Consolidation Chemotherapy
    Evaluable Patients  
STARTED     42  
Eligible     40  
COMPLETED     39  
NOT COMPLETED     3  
not protocol specified                 1  
Ineligible                 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
Evaluable Patients Only eligible patients who received the study intervention were included in the analysis.

Baseline Measures
    Evaluable Patients  
Number of Participants  
[units: participants]
  68  
Age  
[units: years]
Median ( Full Range )
  63  
  ( 39 to 85 )  
Gender  
[units: participants]
 
Female     38  
Male     30  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     2  
Native Hawaiian or Other Pacific Islander     1  
Black or African American     2  
White     63  
More than one race     0  
Unknown or Not Reported     0  



  Outcome Measures
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1.  Primary:   Overall Survival   [ Time Frame: Weekly during protocol treatment, then every 3 months for first year, then every 6 months for up to 3 years after enrollment. ]

2.  Secondary:   Response Rate (Confirmed and Unconfirmed Complete and Partial Responses Per RECIST) in the Subset of Patients With Measurable Disease at Baseline.   [ Time Frame: After completeion of concurrent chemotherapy+radiation (Week 8); then after completion of consolidation chemotherapy (Week15); once off treatment, every 3 months until disease progression for a maximum of 3 years after enrollment. ]

3.  Secondary:   Progression-Free Survival   [ Time Frame: At end of concurrent chemoradiotherapy (Week 8), then at end of consolidation chemotherapy (Week 15). After off treatment, every 3 months for the first 2 years then every 6 months for up to 3 years after enrollment. ]


  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 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: Lung Committee Statistician
Organization: SWOG Statistical Center
phone: 206-652-2267


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00066742     History of Changes
Other Study ID Numbers: NCI-2012-03042, NCI-2012-03042, U10CA032102, S0222, S0222, U10CA032102
Study First Received: August 6, 2003
Results First Received: June 14, 2012
Last Updated: April 29, 2014
Health Authority: United States: Food and Drug Administration