Clinical trial NCT00553696: Study Of Sunitinib With S-1 And Cisplatin For Gastric Cancer
Official title: A Phase 1 Study Of Sunitinib In Combination With S-1 And Cisplatin In Patients With Advanced Or Metastatic Gastric Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Stomach Neoplasms
Keywords: chemotherapy
combination
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-11-04
Enrollment: 27
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess the maximal tolerated dose (MTD) and overall safety of sunitinib when administered in combination with S-1 and Cisplatin in patients with advanced/metastatic gastric cancer.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of gastric cancer
* Chemonaive patients
* Adequate organ function

Exclusion Criteria:

* Patients who meet the contra-indications of S-1 and Cisplatin.
* Prior chemotherapy failure patients

Primary outcomes:
measure: Number of Participants With First Cycle Dose-limiting Toxicities (DLTs)
timeFrame: Cycle 1 (Baseline to Week 4)
Secondary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of Sunitinib, SU-012662, and Total Drug (Sunitinib + SU-012662)
timeFrame: Day 1 of Cycles 1 and 2 (pre-dose, 2, 4, 6, 8, 10, and 24 hours post-dose)
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Sunitinib, SU-012662, and Total Drug (Sunitinib + SU-012662)
timeFrame: Day 1 of Cycles 1 and 2 (pre-dose, 2, 4, 6, 8, 10, and 24 hours post-dose)
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Sunitinib, SU-012662, and Total Drug (Sunitinib + SU-012662)
timeFrame: Day 1 of Cycles 1 and 2 (pre-dose, 2, 4, 6, 8, 10, and 24 hours post-dose)
measure: Maximum Observed Plasma Concentration (Cmax) of Tegafur and 5-FU
timeFrame: Day 1 of Cycles 1 and 2 (pre-dose, 1, 2, 4, 6, 8, and 10 hours post-dose)
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Tegafur and 5-FU
timeFrame: Day 1 of Cycles 1 and 2 (pre-dose, 1, 2, 4, 6, 8, and 10 hours post-dose)
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Tegafur and 5-FU
timeFrame: Day 1 of Cycles 1 and 2 (pre-dose, 1, 2, 4, 6, 8, and 10 hours post-dose)
measure: Maximum Observed Plasma Concentration (Cmax) of Total Platinum and Free Platinum
timeFrame: Day 1 of Cycles 1 and 2 (pre-dose, 0.5, 1, 2, 8, and 22 hours after completing infusion)
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Total Platinum and Free Platinum
timeFrame: Day 1 of Cycles 1 and 2 (pre-dose, 0.5, 1, 2, 8, and 22 hours after completing infusion)
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Total Platinum and Free Platinum
timeFrame: Day 1 of Cycles 1 and 2 (pre-dose, 0.5, 1, 2, 8, and 22 hours after completing infusion)
measure: Number of Participants With Objective Response
timeFrame: Baseline up to 739 days
measure: Number of Participants With Clinical Benefit Response (CBR)
timeFrame: Baseline up to 739 days
measure: Duration of Response (DR)
timeFrame: Baseline up to 739 days
measure: Progression-Free Survival (PFS)
timeFrame: Baseline up to 739 days
measure: Time to Progression (TTP)
timeFrame: Baseline up to 739 days
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Aichi cancer center central hospital / Medical Oncology
state: Aichi
city: Saku
country: Japan
facility: Saku Central Hospital, GI Devision
state: Nagano
city: Suntougun
country: Japan
facility: Shizuoka Cancer Center
state: Shizuoka
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Boku N, Muro K, Machida N, Hashigaki S, Kimura N, Suzuki M, Lechuga M, Miyata Y. Phase I study of sunitinib plus S-1 and cisplatin in Japanese patients with advanced or metastatic gastric cancer. Invest New Drugs. 2014 Apr;32(2):261-70. doi: 10.1007/s10637-013-9948-5. Epub 2013 May 12.