Study Of Sunitinib With FOLFIRI In Colorectal Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00668863
First received: April 25, 2008
Last updated: October 11, 2011
Last verified: October 2011
Results First Received: September 2, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Unresectable or Metastatic Colorectal Cancer
Interventions: Drug: FOLFIRI (The combination regimen of Irinotecan, l-Leucovorin and 5-Fluorouracil)
Drug: Sunitinib

  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
Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.

Participant Flow:   Overall Study
    Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI  
STARTED     71  
COMPLETED     0  
NOT COMPLETED     71  
Objective Progression or Relapse                 42  
Adverse Event                 13  
Study Terminated by Sponsor                 8  
Global Deterioration of Health Status                 4  
Withdrawal by Subject                 1  
Surgery                 1  
Subject’s work scheduling problem                 1  
Physician Decision                 1  



  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
Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI Sunitinib was orally administered at 37.5 mg once daily for 4 consecutive weeks followed by a 2-week rest period to comprise a complete cycle of 6 weeks (Schedule 4/2). Sunitinib was given in combination with FOLFIRI, which was administered in the standard fashion every 2 weeks: Irinotecan (180 mg/m^2) and l-leucovorin (200 mg/m^2) was infused intravenously on Day 1, immediately followed by 5 FU bolus (400 mg/m^2) and 46-hour (2400 mg/m^2) infusion. FOLFIRI was given on Days 1, 15, and 29 in each 6-week cycle of sunitinib administration.

Baseline Measures
    Sunitinib 37.5 mg (Schedule 4/2) + FOLFIRI  
Number of Participants  
[units: participants]
  71  
Age, Customized  
[units: participants]
 
<=44 years     6  
45 to 64 years     44  
>=65 years     21  
Gender  
[units: participants]
 
Female     29  
Male     42  



  Outcome Measures
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1.  Primary:   Progression-Free Survival (PFS)   [ Time Frame: Up to 11 cycles (1 cycle = 6 weeks) ]

2.  Secondary:   Overall Survival (OS)   [ Time Frame: Up to 11 cycles (1 cycle = 6 weeks) ]

3.  Secondary:   Percentage of Participants Who Presented Objective Response: Objective Response Rate (ORR)   [ Time Frame: Up to 11 cycles (1 cycle = 6 weeks) ]

4.  Secondary:   Duration of Response (DR)   [ Time Frame: Up to 11 cycles (1 cycle = 6 weeks) ]

5.  Secondary:   Maximum Observed Plasma Concentration (Cmax) and Predose Concentration (Ctrough) of Sunitinib.   [ Time Frame: Cycle 1 Day 15 ]

6.  Secondary:   Time to Reach Maximum Plasma Concentration (Tmax) of Sunitinib   [ Time Frame: Cycle 1 Day 15 ]

7.  Secondary:   Area Under the Plasma Concentration Versus Time Curve From Time 0 to 24 Hours Postdose (AUC 0-24) of Sunitinib   [ Time Frame: Cycle 1 Day 15 ]

8.  Secondary:   Apparent Oral Clearance (CL/F) of Sunitinib   [ Time Frame: Cycle 1 Day 15 ]

9.  Secondary:   Maximum Observed Plasma Concentration (Cmax) of Irinotecan   [ Time Frame: Cycle 1 Day 15 ]

10.  Secondary:   Time to Reach Maximum Plasma Concentration (Tmax) of Irinotecan   [ Time Frame: Cycle 1 Day 15 ]

11.  Secondary:   Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Measurable Concentration (AUC Last) and Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity (AUC ∞) of Irinotecan   [ Time Frame: Cycle 1 Day 15 ]

12.  Secondary:   Terminal Phase Elimination Half-life (t1/2) of Irinotecan   [ Time Frame: Cycle 1 Day 15 ]

13.  Secondary:   Clearance of Irinotecan   [ Time Frame: Cycle 1 Day 15 ]

14.  Secondary:   Volume of Distribution at Steady State (Vss) of Irinotecan   [ Time Frame: Cycle 1 Day 15 ]

15.  Secondary:   Plasma Concentration at Steady State (Css) of 5-FU   [ Time Frame: Cycle 1 Day 15 ]

16.  Secondary:   Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Grade 3 or Higher Adverse Events According to Common Terminology Criteria (CTCAE).   [ Time Frame: Up to 11 cycles (1 cycle = 6 weeks) ]


  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 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.


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 by Pfizer

Publications automatically indexed to this study:

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00668863     History of Changes
Other Study ID Numbers: A6181151
Study First Received: April 25, 2008
Results First Received: September 2, 2011
Last Updated: October 11, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare