Study Of Sunitinib In Combination With Cisplatin/Capecitabine Or Oxaliplatin/Capecitabine In Patients With Advanced Gastric Cancer

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Pfizer

ClinicalTrials.gov Identifier:

NCT00555620

First received: November 6, 2007

Last updated: January 7, 2013

Last verified: January 2013

History of Changes

Results First Received: August 4, 2011

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Stomach Neoplasms
Interventions:	Drug: capecitabine Drug: oxaliplatin Drug: sunitinib malate Drug: cisplatin

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
SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2	Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.
SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2	SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2	SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2	SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2	SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2	SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.

Participant Flow: Overall Study

	SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2	SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2	SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2
STARTED	6	7	15	23	3	22
COMPLETED	0	0	0	0	0	0
NOT COMPLETED	6	7	15	23	3	22
Death	0	1	0	0	0	1
Study terminated by sponsor	0	0	1	0	0	0
Adverse Event	0	0	1	5	0	1
Objective progression or relapse	6	5	12	17	3	16
Participant refused treatment	0	1	1	0	0	1
Not specified	0	0	0	1	0	3

Baseline Characteristics

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Reporting Groups

	Description
SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2	Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.
SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2	SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2	SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2	SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2	SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2	SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
Total	Total of all reporting groups

Baseline Measures

	SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2	SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2	SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2	Total
Number of Participants [units: participants]	6	7	15	23	3	22	76
Age [units: years] Mean ± Standard Deviation	55.2 ± 5.8	50.0 ± 12.4	50.9 ± 11.3	54.3 ± 10.1	63.3 ± 11.6	50.1 ± 11.5	52.4 ± 10.9
Gender [units: participants]
Female	0	2	6	6	1	8	23
Male	6	5	9	17	2	14	53

Outcome Measures

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1. Primary:

Number of Participants With First-cycle Dose Limiting Toxicities (DLTs) [ Time Frame: Baseline up to Day 21 ]

Show Outcome Measure 1

2. Secondary:

Maximum Observed Plasma Concentration (Cmax) of SU, SU012662 (Metabolite of SU), and Total Drug (SU + SU012662) [ Time Frame: Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose) ]

Show Outcome Measure 2

3. Secondary:

Cmax of CAP [ Time Frame: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) ]

Show Outcome Measure 3

4. Secondary:

Cmax of 5'-Deoxy-5-fluorocytidine (Metabolite of CAP, 5'DFCR) [ Time Frame: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) ]

Show Outcome Measure 4

5. Secondary:

Cmax of 5’-Deoxy-5-fluorouridine (Metabolite of CAP, 5'DFUR) [ Time Frame: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) ]

Show Outcome Measure 5

6. Secondary:

Cmax of 5-fluorouracil (Metabolite of CAP, 5-FU) [ Time Frame: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) ]

Show Outcome Measure 6

7. Secondary:

Minimum Observed Plasma Trough Concentration (Cmin) of SU, SU012662, and Total Drug (SU + SU012662) [ Time Frame: Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose) ]

Show Outcome Measure 7

8. Secondary:

Cmin of CAP [ Time Frame: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) ]

Show Outcome Measure 8

9. Secondary:

Cmin of 5'DFCR [ Time Frame: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) ]

Show Outcome Measure 9

10. Secondary:

Cmin of 5'DFUR [ Time Frame: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) ]

Show Outcome Measure 10

11. Secondary:

Cmin of 5-FU [ Time Frame: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) ]

Show Outcome Measure 11

12. Secondary:

Time to Reach Maximum Observed Plasma Concentration (Tmax) for SU, SU012662, and Total Drug (SU + SU012662) [ Time Frame: Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose) ]

Show Outcome Measure 12

13. Secondary:

Tmax for CAP [ Time Frame: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) ]

Show Outcome Measure 13

14. Secondary:

Tmax for 5'DFCR [ Time Frame: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) ]

Show Outcome Measure 14

15. Secondary:

Tmax for 5'DFUR [ Time Frame: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) ]

Show Outcome Measure 15

16. Secondary:

Tmax for 5-FU [ Time Frame: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) ]

Show Outcome Measure 16

17. Secondary:

Terminal Elimination Half-Life (t1/2) for SU, SU012662, and Total Drug (SU + SU012662) [ Time Frame: Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose) ]

Show Outcome Measure 17

18. Secondary:

t1/2 for CAP [ Time Frame: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) ]

Show Outcome Measure 18

19. Secondary:

t1/2 for 5'DFCR [ Time Frame: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) ]

Show Outcome Measure 19

20. Secondary:

t1/2 for 5'DFUR [ Time Frame: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) ]

Show Outcome Measure 20

21. Secondary:

t1/2 for 5-FU [ Time Frame: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) ]

Show Outcome Measure 21

22. Secondary:

Area Under the Curve From Time 0 to 24 Hours Postdose (AUC [0-24]) for SU, SU012662, and Total Drug (SU + SU012662) [ Time Frame: Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose) ]

Show Outcome Measure 22

23. Secondary:

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]: CAP, 5'DFCR, 5'DFUR, and 5-FU [ Time Frame: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) ]

Show Outcome Measure 23

24. Secondary:

Area Under the Curve From Time Zero to 12 Hours [AUC (12)] for CAP, 5'DFCR, 5'DFUR, and 5-FU [ Time Frame: Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) ]

Show Outcome Measure 24

25. Secondary:

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for CAP [ Time Frame: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) and Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours) ]

Show Outcome Measure 25

26. Secondary:

AUClast for 5'DFCR [ Time Frame: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) and Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours) ]

Show Outcome Measure 26

27. Secondary:

AUClast for 5'DFUR [ Time Frame: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) and Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours) ]

Show Outcome Measure 27

28. Secondary:

AUClast for 5-FU [ Time Frame: Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) and Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours) ]

Show Outcome Measure 28

29. Secondary:

Percentage of Participants With Objective Response [ Time Frame: Baseline, Day 21 of every even-numbered cycle up to 15 months ]

Show Outcome Measure 29

30. Secondary:

Duration of Response (DR) [ Time Frame: Baseline up to Month 15 ]

Show Outcome Measure 30

31. Secondary:

Progression-Free Survival (PFS) [ Time Frame: Baseline up to Month 15 ]

Show Outcome Measure 31

Serious Adverse Events

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Other Adverse Events

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