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

History of Changes

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
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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
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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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 ]

Show Outcome Measure 1

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) ]

Show Outcome Measure 2

3. Secondary:

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

Show Outcome Measure 3

4. Secondary:

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

Show Outcome Measure 4

5. Secondary:

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

Show Outcome Measure 5

6. Secondary:

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

Show Outcome Measure 6

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 ]

Show Outcome Measure 7

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 ]

Show Outcome Measure 8

9. Secondary:

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

Show Outcome Measure 9

10. Secondary:

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

Show Outcome Measure 10

11. Secondary:

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

Show Outcome Measure 11

12. Secondary:

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

Show Outcome Measure 12

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 ]

Show Outcome Measure 13

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 ]

Show Outcome Measure 14

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 ]

Show Outcome Measure 15

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 ]

Show Outcome Measure 16

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 ]

Show Outcome Measure 17

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 ]

Show Outcome Measure 18

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 ]

Show Outcome Measure 19

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 ]

Show Outcome Measure 20

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 ]

Show Outcome Measure 21

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 ]

Show Outcome Measure 22

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 ]

Show Outcome Measure 23

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 ]

Show Outcome Measure 24

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 ]

Show Outcome Measure 25

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 ]

Show Outcome Measure 26

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 ]

Show Outcome Measure 27

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 ]

Show Outcome Measure 28

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) ]

Show Outcome Measure 29

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) ]

Show Outcome Measure 30

Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Pfizer has the right to review disclosures, requesting a delay of < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

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

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