Study Of Sunitinib Plus FOLFOX In Patients With Solid Tumors

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00599924
First received: January 11, 2008
Last updated: December 15, 2009
Last verified: December 2009
Results First Received: November 4, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Colorectal Neoplasms
Neoplasms
Intervention: Drug: sunitinib + FOLFOX

  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
37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2) Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2) Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2) CRC = colorectal cancer. Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2) Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2) Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
37.5 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing) Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
25 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing) Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.

Participant Flow:   Overall Study
    37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)     50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)     50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2)     37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)     50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)     37.5 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)     25 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)  
STARTED     4     9     5     12     9     6     8  
COMPLETED     1     4     3     4     3     2     3  
NOT COMPLETED     3     5     2     8     6     4     5  
Lack of Efficacy                 3                 5                 1                 2                 3                 2                 0  
Adverse Event                 0                 0                 0                 2                 0                 0                 2  
Death                 0                 0                 0                 2                 0                 2                 1  
Protocol Violation                 0                 0                 0                 1                 0                 0                 0  
Lost to Follow-up                 0                 0                 0                 0                 0                 0                 0  
Withdrawal by Subject                 0                 0                 1                 0                 1                 0                 0  
Sponsor Decision                 0                 0                 0                 0                 0                 0                 0  
Unknown                 0                 0                 0                 1                 2                 0                 2  



  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
37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2) Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2) Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2) CRC = colorectal cancer. Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2) Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2) Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
37.5 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing) Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
25 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing) Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
Total Total of all reporting groups

Baseline Measures
    37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)     50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)     50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2)     37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)     50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)     37.5 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)     25 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)     Total  
Number of Participants  
[units: participants]
  4     9     5     12     9     6     8     53  
Age, Customized  
[units: participants]
               
< 65 years     2     6     5     7     6     6     5     37  
> = 65 years     2     3     0     5     3     0     3     16  
Gender  
[units: participants]
               
Female     1     4     2     6     1     2     3     19  
Male     3     5     3     6     8     4     5     34  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)   [ Time Frame: up to 20 weeks ]

2.  Secondary:   Objective Response (OR)   [ Time Frame: From start of treatment until Day 8 of Cycles 4 and 8 (2/2 Schedule), Day 8 of Cycles 3 and 6 (4/2 Schedule), and Day 1 of Cycles 3 and 7 (Continuous Dosing) ]

3.  Secondary:   Maximum Plasma Concentration (Cmax) of Sunitinib   [ Time Frame: pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose ]

4.  Secondary:   Time to Cmax (Tmax) of Sunitinib   [ Time Frame: pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose ]

5.  Secondary:   Minimum Plasma Concentration (Cmin) of Sunitinib   [ Time Frame: pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose ]

6.  Secondary:   Clearance (CL/F) of Sunitinib   [ Time Frame: pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose ]

7.  Secondary:   Area Under Plasma Concentration-Time Profile From Time Zero to Twenty-Four Hours Postdose (AUC24) of Sunitinib   [ Time Frame: pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose ]

8.  Secondary:   Terminal Phase Half-Life (t1/2) of Sunitinib   [ Time Frame: pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose ]

9.  Secondary:   Cmax of SU-012662 (Sunitinib's Metabolite)   [ Time Frame: pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose ]

10.  Secondary:   Tmax of SU-012662 (Sunitinib's Metabolite)   [ Time Frame: pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose ]

11.  Secondary:   Cmin of SU-012662 (Sunitinib's Metabolite)   [ Time Frame: pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose ]

12.  Secondary:   AUC24 for SU-012662 (Sunitinib's Metabolite)   [ Time Frame: pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose. ]

13.  Secondary:   CL/F of SU-012662 (Sunitinib's Metabolite)   [ Time Frame: pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose ]

14.  Secondary:   T1/2 of SU-012662 (Sunitinib's Metabolite)   [ Time Frame: pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose ]

15.  Secondary:   Cmax of Free Platinum   [ Time Frame: pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose ]

16.  Secondary:   Tmax of Free Platinum   [ Time Frame: pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose ]

17.  Secondary:   Area Under the Plasma Concentration-Time Profile From Time Zero to Infinity (AUCinf) for Free Platinum   [ Time Frame: pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose ]

18.  Secondary:   T1/2 for Free Platinum   [ Time Frame: pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose ]

19.  Secondary:   Cmax of Total Platinum   [ Time Frame: pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose ]

20.  Secondary:   Tmax of Total Platinum   [ Time Frame: pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose ]

21.  Secondary:   Area Under the Plasma Concentration-Time Profile From Time Zero to Forty-Eight Hours (AUC48) for Total Platinum   [ Time Frame: pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose ]

22.  Secondary:   Steady State Concentration (Css) of Fluorouracil (5-FU)   [ Time Frame: pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose ]

23.  Secondary:   Steady State Clearance (CLss) of 5-FU   [ Time Frame: pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose ]

24.  Secondary:   Area Under the Curve (AUC) of 5-FU   [ Time Frame: pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose ]

25.  Secondary:   Cmax of 5-FU   [ Time Frame: pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose ]

26.  Secondary:   T1/2 of Free Platinum, Total Platinum, and 5-FU   [ Time Frame: pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose ]

27.  Secondary:   CL/F of Free Platinum, Total Platinum, and 5-FU   [ Time Frame: pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose ]

28.  Secondary:   Cmin of Free Platinum, Total Platinum, and 5-FU   [ Time Frame: pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose ]

29.  Secondary:   Volume Endothelial Transfer Constant (Ktrans) of Tumors in a Selected Group of Subjects Assessed by Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI)   [ Time Frame: Cycle 3 (Day 1), Cycle 3 (Day 8) ]

30.  Secondary:   Initial Area Dnder the Contrast Agent Concentration-Time Curve (IAUC) of Tumors in a Selected Group of Subjects Assessed by DCE-MRI   [ Time Frame: Cycle 3 (Day 1) and Cycle 3 (Day 8) ]


  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.govCallCenter@pfizer.com


No publications provided


Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00599924     History of Changes
Other Study ID Numbers: A6181048
Study First Received: January 11, 2008
Results First Received: November 4, 2009
Last Updated: December 15, 2009
Health Authority: United States: Food and Drug Administration