A Phase I Study Of Sunitinib Malate In Combination With Cisplatin And 5-Fluorouracil In Patients With Advanced Gastric Cancer

Pfizer1 site in 1 country34 target enrollmentAugust 2008

ConditionsStomach Neoplasms

Interventions5-fluorouracil cisplatin sunitinib malate

Drugs5-fluorouracil cisplatin sunitinib malate

Overview

Phase: Phase 1
Intervention: 5-fluorouracil
Conditions: Stomach Neoplasms
Sponsor: Pfizer
Enrollment: 34
Locations: 1
Primary Endpoint: Number of Participants With First-cycle Dose Limiting Toxicities (DLTs)
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2008

End Date

August 2010

Last Updated

14 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Pfizer

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

A

Intervention: 5-fluorouracil

A

Intervention: cisplatin

A

Intervention: sunitinib malate

Outcomes

Primary Outcomes

Number of Participants With First-cycle Dose Limiting Toxicities (DLTs)

Time Frame: Cycle 1 (Baseline to Day 21)

The incidence of DLTs assessed during the first cycle (21 days).

Secondary Outcomes

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))
Time to Reach Maximum Observed Plasma Concentration (Tmax)(Day 1 of Cycle 1 (2, 4, 6, 8, 10, and 24 hours post dose))
Steady State Concentration (Css) of 5-Fluorouracil (5-FU)(Day 1 of Cycle 1 (2, 4, and 6 hours post infusion))
Infusion Rate (Zero Order) (R0) of 5-FU(Day 1 of Cycle 1 (2, 4, and 6 hours post infusion))
Clearance (CLss) of 5-FU(Day 1 of Cycle 1 (2, 4, and 6 hours post infusion))
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))
Number of Participants With Objective Response(Baseline, Day 21 of every even-numbered cycle up to 15 Months)
Duration of Response (DR)(Baseline up to Month 15)
Progression-Free Survival (PFS)(Baseline up to Month 15)