Study Of Sunitinib With S-1 And Cisplatin For Gastric Cancer

Stomach Neoplasms Clinical Trial

Official title:

A Phase 1 Study Of Sunitinib In Combination With S-1 And Cisplatin In Patients With Advanced Or Metastatic Gastric Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00553696
• Other study ID #: A6181127
• Status: Completed
• Phase: Phase 1
• First received: November 2, 2007
• Last updated: March 3, 2015
• Start date: November 2007
• Est. completion date: March 2014

Study information

• Verified date: March 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: March 2014
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stomach Neoplasms

Intervention

Drug:
• Cisplatin
Cisplatin 60 mg/m2 on day 1 of each 28 day cycle
• S-1
S-1 80 mg/m2 on days 1-21 of each 28 day cycle
• Sunitinib
Sunitinib 25 mg, 37.5 mg and 50 mg daily S-1 80 mg/m2 on days 1-21 of each 28 day cycle Cisplatin 60 mg/m2 on day 1 of each 28 day cycle

Locations

Country	Name	City	State
Japan	Aichi cancer center central hospital / Medical Oncology	Nagoya	Aichi
Japan	Saku Central Hospital, GI Devision	Saku	Nagano
Japan	Shizuoka Cancer Center	Suntougun	Shizuoka

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With First Cycle Dose-limiting Toxicities (DLTs)	A DLT is any of a predefined set of unacceptable adverse events, regardless of cause. DLTs were assessed during the first cycle (4 weeks).	Cycle 1 (Baseline to Week 4)	Yes
Secondary	Maximum Observed Plasma Concentration (Cmax) of Sunitinib, SU-012662, and Total Drug (Sunitinib + SU-012662)		Day 1 of Cycles 1 and 2 (pre-dose, 2, 4, 6, 8, 10, and 24 hours post-dose)	No
Secondary	Time to Reach Maximum Observed Plasma Concentration (Tmax) of Sunitinib, SU-012662, and Total Drug (Sunitinib + SU-012662)		Day 1 of Cycles 1 and 2 (pre-dose, 2, 4, 6, 8, 10, and 24 hours post-dose)	No
Secondary	Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Sunitinib, SU-012662, and Total Drug (Sunitinib + SU-012662)	Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)	Day 1 of Cycles 1 and 2 (pre-dose, 2, 4, 6, 8, 10, and 24 hours post-dose)	No
Secondary	Maximum Observed Plasma Concentration (Cmax) of Tegafur and 5-FU		Day 1 of Cycles 1 and 2 (pre-dose, 1, 2, 4, 6, 8, and 10 hours post-dose)	No
Secondary	Time to Reach Maximum Observed Plasma Concentration (Tmax) of Tegafur and 5-FU		Day 1 of Cycles 1 and 2 (pre-dose, 1, 2, 4, 6, 8, and 10 hours post-dose)	No
Secondary	Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Tegafur and 5-FU	Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)	Day 1 of Cycles 1 and 2 (pre-dose, 1, 2, 4, 6, 8, and 10 hours post-dose)	No
Secondary	Maximum Observed Plasma Concentration (Cmax) of Total Platinum and Free Platinum		Day 1 of Cycles 1 and 2 (pre-dose, 0.5, 1, 2, 8, and 22 hours after completing infusion)	No
Secondary	Time to Reach Maximum Observed Plasma Concentration (Tmax) of Total Platinum and Free Platinum		Day 1 of Cycles 1 and 2 (pre-dose, 0.5, 1, 2, 8, and 22 hours after completing infusion)	No
Secondary	Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Total Platinum and Free Platinum	Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)	Day 1 of Cycles 1 and 2 (pre-dose, 0.5, 1, 2, 8, and 22 hours after completing infusion)	No
Secondary	Number of Participants With Objective Response	Number of participants with 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. Confirmed responses are those that persist on repeat imaging at least 4 weeks after initial documentation of response.	Baseline up to 739 days	No
Secondary	Number of Participants With Clinical Benefit Response (CBR)	CBR is defined as a confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD) for at least 24 weeks on study according to RECIST. Confirmed responses are those that persist on repeat imaging at least 4 weeks after initial documentation of response.	Baseline up to 739 days	No
Secondary	Duration of Response (DR)	Time from the first objective documentation of tumor response (confirmed or partial response) to first documented objective tumor progression or death due to cancer. DR calculated as (the end date for DR minus first subsequent confirmed CR or PR plus 1 day).	Baseline up to 739 days	No
Secondary	Progression-Free Survival (PFS)	Median time from the enrollment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first. PFS calculated as (first event date minus enrollment date plus 1 day)	Baseline up to 739 days	No
Secondary	Time to Progression (TTP)	Time in months from enrollment to first documentation of objective tumor progression. TTP was calculated as (first event date or last known progression-free date minus the date of enrollment plus 1 day). Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD] per RECIST).	Baseline up to 739 days	No

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