7-hydroxystaurosporine and Topotecan Hydrochloride in Treating Patients With Relapsed or Progressed Small Cell Lung Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00098956
First received: December 8, 2004
Last updated: August 10, 2015
Last verified: October 2013
Results First Received: August 10, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Extensive Stage Small Cell Lung Cancer
Recurrent Small Cell Lung Cancer
Interventions: Drug: topotecan hydrochloride
Drug: 7-hydroxystaurosporine

  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
Treatment (Topotecan Hydrochloride, UCN-01)

Patients receive topotecan IV over 30 minutes on days 1-5 and UCN-01 IV over 3 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR receive 2 additional courses beyond CR or PR.

topotecan hydrochloride: Given IV

7-hydroxystaurosporine: Given IV


Participant Flow:   Overall Study
    Treatment (Topotecan Hydrochloride, UCN-01)  
STARTED     19  
COMPLETED     19  
NOT COMPLETED     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
Treatment (Topotecan Hydrochloride, UCN-01)

Patients receive topotecan IV over 30 minutes on days 1-5 and UCN-01 IV over 3 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR receive 2 additional courses beyond CR or PR.

topotecan hydrochloride: Given IV

7-hydroxystaurosporine: Given IV


Baseline Measures
    Treatment (Topotecan Hydrochloride, UCN-01)  
Number of Participants  
[units: participants]
  19  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     12  
>=65 years     7  
Age  
[units: years]
Mean (Full Range)
  59  
  (51 to 73)  
Gender  
[units: participants]
 
Female     10  
Male     9  
Region of Enrollment  
[units: participants]
 
Canada     19  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Objective Response Rates (Complete and Partial) Evaluated Using RECIST Criteria   [ Time Frame: Up to 5 years ]

2.  Secondary:   Stable Disease Rate Evaluated Using RECIST Criteria   [ Time Frame: Up to 5 years ]

3.  Secondary:   Duration of Responses   [ Time Frame: From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Progression-free Survival   [ Time Frame: From the date of enrollment to progression, death or last contact, or last tumor assessment before the start of further anti-tumor therapy, assessed up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Overall Survival   [ Time Frame: From the date of enrollment to death or last contact, assessed up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Adverse Events, Graded Using the CTCAE Version 3.0   [ Time Frame: Up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  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: Dr. Glenwood Goss
Organization: The Ottawa Hospital
phone: 613-737-7700 ext 56708
e-mail: ggoss@ottawahospital.on.ca



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00098956     History of Changes
Other Study ID Numbers: NCI-2012-03092
NCI-2012-03092 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
6992
PHL032 ( Other Identifier: Princess Margaret Hospital Phase 2 Consortium )
6992 ( Other Identifier: CTEP )
N01CM62203 ( US NIH Grant/Contract Award Number )
Study First Received: December 8, 2004
Results First Received: August 10, 2015
Last Updated: August 10, 2015
Health Authority: United States: Food and Drug Administration