SB-715992 in Treating Patients With Advanced or Metastatic Colorectal Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00103311
First received: February 7, 2005
Last updated: February 13, 2015
Last verified: October 2013
Results First Received: February 13, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Recurrent Colon Cancer
Recurrent Rectal Cancer
Stage IIIA Colon Cancer
Stage IIIA Rectal Cancer
Stage IIIB Colon Cancer
Stage IIIB Rectal Cancer
Stage IIIC Colon Cancer
Stage IIIC Rectal Cancer
Stage IVA Colon Cancer
Stage IVA Rectal Cancer
Stage IVB Colon Cancer
Stage IVB Rectal Cancer
Interventions: Drug: ispinesib
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
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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
Arm I

Patients receive SB-715992 IV at 7 mg/m2 over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

ispinesib: Given IV

laboratory biomarker analysis: Correlative studies

Arm II

Patients receive SB-715992 IV at 18 mg/m2 over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ispinesib: Given IV

laboratory biomarker analysis: Correlative studies


Participant Flow:   Overall Study
    Arm I     Arm II  
STARTED     33     31  
COMPLETED     29     30  
NOT COMPLETED     4     1  
Lost to Follow-up                 1                 0  
Withdrawal by Subject                 2                 1  
Adverse Event                 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
Arm I

Patients receive SB-715992 IV at 7 mg/m2 over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

ispinesib: Given IV

laboratory biomarker analysis: Correlative studies

Arm II

Patients receive SB-715992 IV at 18 mg/m2 over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ispinesib: Given IV

laboratory biomarker analysis: Correlative studies

Total Total of all reporting groups

Baseline Measures
    Arm I     Arm II     Total  
Number of Participants  
[units: participants]
  33     31     64  
Age  
[units: years]
Median (Full Range)
  59   (28 to 82)     60   (35 to 80)     59   (28 to 82)  
Gender  
[units: participants]
     
Female     14     13     27  
Male     19     18     37  
Region of Enrollment  
[units: participants]
     
United States     33     31     64  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Objective Response (CR or PR) as Determined by the RECIST Criteria   [ Time Frame: Up to 5 years ]

2.  Secondary:   Progression-free Survival   [ Time Frame: From the date of registration to the date of documented PSA progression, assessed up to 6 months ]

3.  Secondary:   Overall Survival   [ Time Frame: From the date of registration to the date of death, assessed up to 12 months ]


  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: DCC Project Administrator
Organization: California Cancer Consortium
phone: 626-256-4673 ext 60094
e-mail: CCCP@coh.org


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00103311     History of Changes
Other Study ID Numbers: NCI-2012-02834, NCI-2012-02834, PHII-51, 6800
Study First Received: February 7, 2005
Results First Received: February 13, 2015
Last Updated: February 13, 2015
Health Authority: United States: Food and Drug Administration