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Oral Topotecan to Treat Recurrent or Persistent Solid Tumors

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Accelerated Community Oncology Research Network
ClinicalTrials.gov Identifier:
NCT00382733
First received: September 27, 2006
Last updated: July 17, 2013
Last verified: July 2013
Results First Received: May 10, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Tumors
Intervention: Drug: Oral Topotecan

  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
The study was open to enrollment at one community oncology clinic from November 2006 to May 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Informed consent was obtained from all subjects. All subjects underwent a screening period that could last up to 4 weeks during which pre-study assessments were completed. During the dose finding portion of the study, subjects were assigned to a Dose Level during enrollment. Once the MTD was determined, additional subjects were treated at the MTD.

Reporting Groups
  Description
Oral Topotecan 0.25 mg Daily All subjects in this group were assigned to receive metronomic oral topotecan 0.25 mg daily (Dose Level 1).
Oral Topotecan 0.50 mg Daily All subjects in this group were assigned to receive metronomic oral topotecan 0.50 mg daily (Dose Level 2).
Oral Topotecan 0.75 mg Daily All subjects in this group were assigned to receive metronomic oral topotecan 0.75 mg daily (Dose Level 3).
Oral Topotecan 1.0 mg Daily All subjects in this group were assigned to receive metronomic oral topotecan 1.0 mg daily (Dose Level 4).
Oral Topotecan 1.25 mg Daily All subjects in this group were assigned to receive metronomic oral topotecan 1.25 mg daily (Dose Level 5).

Participant Flow:   Overall Study
    Oral Topotecan 0.25 mg Daily     Oral Topotecan 0.50 mg Daily     Oral Topotecan 0.75 mg Daily     Oral Topotecan 1.0 mg Daily     Oral Topotecan 1.25 mg Daily  
STARTED     3     4     3     14     2  
COMPLETED     3     3 [1]   3     14     2  
NOT COMPLETED     0     1     0     0     0  
Withdrawal by Subject                 0                 1                 0                 0                 0  
[1] 1 subject withdrew consent before completing Cycle 1 - that subject was replaced



  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.
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Reporting Groups
  Description
Metronomic Oral Topotecan All subjects received metronomic oral topotecan daily at the assigned dose level.

Baseline Measures
    Metronomic Oral Topotecan  
Number of Participants  
[units: participants]
  26  
Age  
[units: years]
Mean ± Standard Deviation
  65.6  ± 8.99  
Gender  
[units: participants]
 
Female     20  
Male     6  
Region of Enrollment  
[units: participants]
 
United States     26  



  Outcome Measures
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1.  Primary:   Maximum Tolerated Dose (MTD) of Single Agent Metronomic Oral Topotecan   [ Time Frame: MTD was assessed during the first cycle of treatment (days 1-28). ]

2.  Secondary:   Dose Limiting Toxicities (DLT)   [ Time Frame: DLTs were assessed during the first cycle of treatment (days 1-28). ]

3.  Secondary:   Best Overall Response   [ Time Frame: Best overall response was assessed after every 8 weeks of treatment and at the end of treatment or time of disease progression, up to 1 year. ]


  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: Vice President of Scientific Affairs
Organization: Accelerated Community Oncology Research Network, Inc.
e-mail: mwalker@acorncro.com


No publications provided


Responsible Party: Accelerated Community Oncology Research Network
ClinicalTrials.gov Identifier: NCT00382733     History of Changes
Other Study ID Numbers: ACORN ATDTROC0501
Study First Received: September 27, 2006
Results First Received: May 10, 2013
Last Updated: July 17, 2013
Health Authority: United States: Institutional Review Board