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

Stomach Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00555672
• Other study ID #: A6181128
• Status: Completed
• Phase: Phase 1
• First received: November 8, 2007
• Last updated: December 12, 2011
• Start date: August 2008
• Est. completion date: August 2010

Study information

• Verified date: December 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: August 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stomach Neoplasms

Intervention

Drug:
• 5-fluorouracil
5- fluorouracil is given as 4000 mg/m^2 total dose over 96 hr continuous infusion of a 21 day chemotherapy cycle. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed.
• cisplatin
Cisplatin is given 80 mg/m^2 through a vein on day 1 every 21 days. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed.
• sunitinib malate
sunitinib is given orally 37.5mg /day for 14 days followed by 7 days of drug free period. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed.

Locations

Country	Name	City	State
Spain	Pfizer Investigational Site	Barcelona
Spain	Pfizer Investigational Site	L'hospitalet de Llobregat	Barcelona
Spain	Pfizer Investigational Site	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With First-cycle Dose Limiting Toxicities (DLTs)	The incidence of DLTs assessed during the first cycle (21 days).	Cycle 1 (Baseline to Day 21)	Yes
Secondary	Maximum Observed Plasma Concentration (Cmax)		Day 1 of Cycle 1 (2, 4, 6, 8, 10, and 24 hours post dose)	No
Secondary	Area Under the Curve From Time 0 to 24 Hours Postdose [AUC (0-24)]	Area under the plasma concentration versus time curve from time 0 (pre-dose) to 24 hours postdose (0-24).	Day 1 of Cycle 1 (2, 4, 6, 8, 10, and 24 hours postdose)	No
Secondary	Time to Reach Maximum Observed Plasma Concentration (Tmax)	Tmax is the time to first occurrence of maximum observed plasma concentration (Cmax).	Day 1 of Cycle 1 (2, 4, 6, 8, 10, and 24 hours post dose)	No
Secondary	Steady State Concentration (Css) of 5-Fluorouracil (5-FU)	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).	Day 1 of Cycle 1 (2, 4, and 6 hours post infusion)	No
Secondary	Infusion Rate (Zero Order) (R0) of 5-FU	Infusion rate of 5-FU equals total dose divided by infusion time.	Day 1 of Cycle 1 (2, 4, and 6 hours post infusion)	No
Secondary	Clearance (CLss) of 5-FU	Steady state total body clearance equals infusion rate (zero order) divided by steady state plasma concentration of 5-FU (R0/Css).	Day 1 of Cycle 1 (2, 4, and 6 hours post infusion)	No
Secondary	Area Under the Curve From Time 2 to 6 Hours Postdose [AUC (2-6)] of 5-FU	Area under the plasma concentration versus time curve from time 2 to 6 hours postdose (2-6).	Day 1 of Cycle 1 (2, 4, and 6 hours post infusion)	No
Secondary	Number of Participants With Objective Response	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.	Baseline, Day 21 of every even-numbered cycle up to 15 Months	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 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.	Baseline up to Month 15	No
Secondary	Progression-Free Survival (PFS)	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.	Baseline up to Month 15	No

External Links

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