We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00098956
First Posted: December 9, 2004
Last Update Posted: September 9, 2015
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.
Information provided by (Responsible Party):
National Cancer Institute (NCI)
Results First Submitted: August 10, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (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
  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
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


Participant Flow:   Overall Study
    Treatment (Topotecan Hydrochloride, UCN-01)
STARTED   19 
COMPLETED   19 
NOT COMPLETED   0 



  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
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) 
Overall Participants Analyzed 
[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.  

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.  

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.  

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.  


  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: 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 ( U.S. NIH Grant/Contract )
First Submitted: December 8, 2004
First Posted: December 9, 2004
Results First Submitted: August 10, 2015
Results First Posted: September 9, 2015
Last Update Posted: September 9, 2015