Study Of Sunitinib In Combination With Cisplatin And 5-Fluorouracil In Patients With Advanced Gastric Cancer

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Pfizer

ClinicalTrials.gov Identifier:

NCT00555672

First received: November 8, 2007

Last updated: December 12, 2011

Last verified: December 2011

History of Changes

Results First Received: December 15, 2010

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:	Stomach Neoplasms
Interventions:	Drug: 5-fluorouracil Drug: cisplatin Drug: sunitinib malate

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 (25 mg) in Combination With Cisplatin and 5-FU	Sunitinib: 25 milligram (mg) oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) intravenous on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
Sunitinib (37.5 mg) in Combination With Cisplatin and 5-FU	Sunitinib: 37.5 mg oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.

Participant Flow: Overall Study

	Sunitinib (25 mg) in Combination With Cisplatin and 5-FU	Sunitinib (37.5 mg) in Combination With Cisplatin and 5-FU
STARTED	24	10
COMPLETED	0	0
NOT COMPLETED	24	10
Death	0	2
Adverse Event	8	2
Objective progression or relapse	11	5
Unspecified	3	1
Participant refused	2	0

Baseline Characteristics

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Reporting Groups

	Description
Sunitinib (25 mg) in Combination With Cisplatin and 5-FU	Sunitinib: 25 milligram (mg) oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) intravenous on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
Sunitinib (37.5 mg) in Combination With Cisplatin and 5-FU	Sunitinib: 37.5 mg oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
Total	Total of all reporting groups

Baseline Measures

	Sunitinib (25 mg) in Combination With Cisplatin and 5-FU	Sunitinib (37.5 mg) in Combination With Cisplatin and 5-FU	Total
Number of Participants [units: participants]	24	10	34
Age [units: years] Mean ± Standard Deviation	60.1 ± 12.0	56.4 ± 10.4	59.0 ± 11.5
Gender [units: participants]
Female	7	4	11
Male	17	6	23

Outcome Measures

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1. Primary:

Number of Participants With First-cycle Dose Limiting Toxicities (DLTs) [ Time Frame: Cycle 1 (Baseline to Day 21) ]

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2. Secondary:

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

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3. Secondary:

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

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4. Secondary:

Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: Day 1 of Cycle 1 (2, 4, 6, 8, 10, and 24 hours post dose) ]

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5. Secondary:

Steady State Concentration (Css) of 5-Fluorouracil (5-FU) [ Time Frame: Day 1 of Cycle 1 (2, 4, and 6 hours post infusion) ]

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6. Secondary:

Infusion Rate (Zero Order) (R0) of 5-FU [ Time Frame: Day 1 of Cycle 1 (2, 4, and 6 hours post infusion) ]

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7. Secondary:

Clearance (CLss) of 5-FU [ Time Frame: Day 1 of Cycle 1 (2, 4, and 6 hours post infusion) ]

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8. Secondary:

Area Under the Curve From Time 2 to 6 Hours Postdose [AUC (2-6)] of 5-FU [ Time Frame: Day 1 of Cycle 1 (2, 4, and 6 hours post infusion) ]

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9. Secondary:

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

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10. Secondary:

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

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11. Secondary:

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

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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 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
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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:	NCT00555672 History of Changes
Other Study ID Numbers:	A6181128
Study First Received:	November 8, 2007
Results First Received:	December 15, 2010
Last Updated:	December 12, 2011
Health Authority:	United States: Food and Drug Administration

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