Study Of Sunitinib In Combination With Folfox In Patients With Colorectal Cancer

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00631410
First received: January 2, 2008
Last updated: March 11, 2011
Last verified: March 2011
Results First Received: July 21, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Colorectal Neoplasms
Intervention: Drug: sunitinib + mFOLFOX6

  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
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 Arm A 37.5 mg/Day (4/2) Sunitinib was administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 37.5 mg/day (37.5 mg/day in Schedule 4/2). A combination chemotherapy of fluorouracil, calcium folinate and oxaliplatin (FOLFOX) was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle.
Treatment Arm B 50 mg/Day (2/2) Sunitinib was administered orally in a 2 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 50 mg/day (50 mg/day in Schedule 2/2). A combination chemotherapy of fluorouracil, calcium folinate and oxaliplatin (FOLFOX) was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle.

Participant Flow:   Overall Study
    Treatment Arm A 37.5 mg/Day (4/2)     Treatment Arm B 50 mg/Day (2/2)  
STARTED     6     6  
COMPLETED     0     0  
NOT COMPLETED     6     6  
Adverse Event                 1                 3  
Objective Progression or Relapse                 4                 3  
Surgery                 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
Treatment Arm A 37.5 mg/Day (4/2) Sunitinib was administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 37.5 mg/day (37.5 mg/day in Schedule 4/2). FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle.
Treatment Arm B 50 mg/Day (2/2)

Sunitinib was administered orally in a 2 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 50 mg/day (50 mg/day in Schedule 2/2).

FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle.

Total Total of all reporting groups

Baseline Measures
    Treatment Arm A 37.5 mg/Day (4/2)     Treatment Arm B 50 mg/Day (2/2)     Total  
Number of Participants  
[units: participants]
  6     6     12  
Age, Customized  
[units: participants]
     
20-44 years     0     0     0  
45-64 years     4     3     7  
>=65 years     2     3     5  
Gender  
[units: participants]
     
Female     1     1     2  
Male     5     5     10  
Eastern Cooperative Oncology Group (ECOG) Performance Status [1]
[units: participants]
     
Score 0     5     6     11  
Score 1     1     0     1  
[1]

Score 0: Fully active, able to carry on all pre-disease performance without restriction; Score

1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, such as light house work and office work.




  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Adverse Events   [ Time Frame: Up to 733 days (the last subject study discontinuation) ]

2.  Secondary:   Plasma Concentration of Sunitinib   [ Time Frame: Cycle 1 Day 14 and Cycle 2 Day 1 ]

3.  Secondary:   Plasma Concentration of Sunitinib Active Metabolite (SU012662)   [ Time Frame: Cycle 1 Day 14 and Cycle 2 Day 1 ]

4.  Secondary:   Plasma Concentration of the Total Drug (Sunitinib Plus SU012662)   [ Time Frame: Cycle 1 Day 14 and Cycle 2 Day 1 ]

5.  Secondary:   Best Overall Response Based on Response Evaluation Criteria in Solid Tumors (RECIST)   [ Time Frame: Up to the last subject completed Cycle 24 or individual study discontinuation ]

6.  Secondary:   Duration of Response (DR)   [ Time Frame: Up to 733 days (the last subject study discontinuation) ]

7.  Secondary:   Progression-Free Survival (PFS)   [ Time Frame: Up to 733 days (the last subject study discontinuation) ]

8.  Secondary:   Sunitinib Relative Dose Intensity in the Treatment Arm A   [ Time Frame: Up to 733 days (the last subject study discontinuation in the Treatment Arm A) ]

9.  Secondary:   Sunitinib Relative Dose Intensity in the Treatment Arm B   [ Time Frame: Up to 384 days (the last subject study discontinuation in the Treatment Arm B) ]


  Serious Adverse Events


  Other Adverse Events


  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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


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.  


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


No publications provided


Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00631410     History of Changes
Other Study ID Numbers: A6181148
Study First Received: January 2, 2008
Results First Received: July 21, 2010
Last Updated: March 11, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare