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

Hide Participant Flow

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
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

Hide Baseline Characteristics

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

Show All Outcome Measures

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

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

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 less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 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.gov_Inquiries@pfizer.com

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00555620 History of Changes
Other Study ID Numbers:	A6181126
Study First Received:	November 6, 2007
Results First Received:	August 4, 2011
Last Updated:	January 7, 2013
Health Authority:	United States: Food and Drug Administration

To Top