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

Phase 1

Completed

• Conditions: Stomach Neoplasms
• Interventions: Drug: 5-fluorouracil; Drug: cisplatin; Drug: sunitinib malate

• Registration Number: NCT00555672
• Lead Sponsor: Pfizer

Brief Summary

The purpose of this study is to determine the safe and tolerable dose of sunitinib when given together with cisplatin and 5-fluorouracil in patients with advanced gastric cancer who have not received prior chemotherapy for their advanced cancer.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-11-08
• Study First Submitted QC: 2007-11-08
• Study First Posted: 2007-11-09
• Study Start: 2008-08
• Primary Completion: 2009-12
• Study Completion: 2010-08
• Results First Submitted: 2010-12-15
• Results First Submitted QC: 2010-12-15
• Results First Posted: 2011-01-05
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-12
• Last Update Posted: 2011-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• confirmed diagnosis of stomach cancer
• advanced stomach cancer stage IV
• adequate blood chemistry, blood counts and kidney function
• willing to participate to study requirements and to sign an informed consent document

Exclusion Criteria

• prior chemotherapy for stomach cancer in its advanced stage
• excessive toxicities related to prior therapies
• pregnant or breastfeeding patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	5-fluorouracil	-
A	cisplatin	-
A	sunitinib malate	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With First-cycle Dose Limiting Toxicities (DLTs)	Cycle 1 (Baseline to Day 21)	The incidence of DLTs assessed during the first cycle (21 days).

Secondary Outcome Measures

Name	Time	Method
Maximum Observed Plasma Concentration (Cmax)	Day 1 of Cycle 1 (2, 4, 6, 8, 10, and 24 hours post dose)
Area Under the Curve From Time 0 to 24 Hours Postdose [AUC (0-24)]	Day 1 of Cycle 1 (2, 4, 6, 8, 10, and 24 hours postdose)	Area under the plasma concentration versus time curve from time 0 (pre-dose) to 24 hours postdose (0-24).
Time to Reach Maximum Observed Plasma Concentration (Tmax)	Day 1 of Cycle 1 (2, 4, 6, 8, 10, and 24 hours post dose)	Tmax is the time to first occurrence of maximum observed plasma concentration (Cmax).
Steady State Concentration (Css) of 5-Fluorouracil (5-FU)	Day 1 of Cycle 1 (2, 4, and 6 hours post infusion)	Steady state plasma concentration of 5-FU equals AUC(2-6) divided by 4, where AUC(2-6) is the area under the plasma concentration versus time curve from time 2 to 6 hours postdose (2-6).
Infusion Rate (Zero Order) (R0) of 5-FU	Day 1 of Cycle 1 (2, 4, and 6 hours post infusion)	Infusion rate of 5-FU equals total dose divided by infusion time.
Clearance (CLss) of 5-FU	Day 1 of Cycle 1 (2, 4, and 6 hours post infusion)	Steady state total body clearance equals infusion rate (zero order) divided by steady state plasma concentration of 5-FU (R0/Css).
Area Under the Curve From Time 2 to 6 Hours Postdose [AUC (2-6)] of 5-FU	Day 1 of Cycle 1 (2, 4, and 6 hours post infusion)	Area under the plasma concentration versus time curve from time 2 to 6 hours postdose (2-6).
Number of Participants With Objective Response	Baseline, Day 21 of every even-numbered cycle up to 15 Months	Number of participants with an objective response-based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as the disappearance of all target lesions. PR defined as greater than or equal to (≥) 30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
Duration of Response (DR)	Baseline up to Month 15	Time from the first objective documentation of tumor response (confirmed or partial response) to first documented objective tumor progression or death due to any cause, whichever occurrs first. DR calculated as (Months) equals (the end date for DR minus first subsequent confirmed CR or PR plus 1) divided by 30.
Progression-Free Survival (PFS)	Baseline up to Month 15	Median time (50%) from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first. PFS calculated as (Months) equals (first event date minus first dose date plus 1) divided by 30.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇪🇸 Madrid, Spain