Study Of Sunitinib In Combination With Cisplatin And 5-Fluorouracil In Patients With Advanced Gastric Cancer
Primary Purpose
Stomach Neoplasms
Status
Completed
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
5-fluorouracil
cisplatin
sunitinib malate
Sponsored by
About this trial
This is an interventional treatment trial for Stomach Neoplasms
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
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
Outcomes
Primary Outcome Measures
Number of Participants With First-cycle Dose Limiting Toxicities (DLTs)
The incidence of DLTs assessed during the first cycle (21 days).
Secondary Outcome Measures
Maximum Observed Plasma Concentration (Cmax)
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).
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Tmax is the time to first occurrence of maximum observed plasma concentration (Cmax).
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).
Infusion Rate (Zero Order) (R0) of 5-FU
Infusion rate of 5-FU equals total dose divided by infusion time.
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).
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).
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00555672
Brief Title
Study Of Sunitinib In Combination With Cisplatin And 5-Fluorouracil In Patients With Advanced Gastric Cancer
Official Title
A Phase I Study Of Sunitinib Malate In Combination With Cisplatin And 5-Fluorouracil In Patients With Advanced Gastric Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
August 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
5-fluorouracil
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
sunitinib malate
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants With First-cycle Dose Limiting Toxicities (DLTs)
Description
The incidence of DLTs assessed during the first cycle (21 days).
Time Frame
Cycle 1 (Baseline to Day 21)
Secondary Outcome Measure Information:
Title
Maximum Observed Plasma Concentration (Cmax)
Time Frame
Day 1 of Cycle 1 (2, 4, 6, 8, 10, and 24 hours post dose)
Title
Area Under the Curve From Time 0 to 24 Hours Postdose [AUC (0-24)]
Description
Area under the plasma concentration versus time curve from time 0 (pre-dose) to 24 hours postdose (0-24).
Time Frame
Day 1 of Cycle 1 (2, 4, 6, 8, 10, and 24 hours postdose)
Title
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Description
Tmax is the time to first occurrence of maximum observed plasma concentration (Cmax).
Time Frame
Day 1 of Cycle 1 (2, 4, 6, 8, 10, and 24 hours post dose)
Title
Steady State Concentration (Css) of 5-Fluorouracil (5-FU)
Description
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).
Time Frame
Day 1 of Cycle 1 (2, 4, and 6 hours post infusion)
Title
Infusion Rate (Zero Order) (R0) of 5-FU
Description
Infusion rate of 5-FU equals total dose divided by infusion time.
Time Frame
Day 1 of Cycle 1 (2, 4, and 6 hours post infusion)
Title
Clearance (CLss) of 5-FU
Description
Steady state total body clearance equals infusion rate (zero order) divided by steady state plasma concentration of 5-FU (R0/Css).
Time Frame
Day 1 of Cycle 1 (2, 4, and 6 hours post infusion)
Title
Area Under the Curve From Time 2 to 6 Hours Postdose [AUC (2-6)] of 5-FU
Description
Area under the plasma concentration versus time curve from time 2 to 6 hours postdose (2-6).
Time Frame
Day 1 of Cycle 1 (2, 4, and 6 hours post infusion)
Title
Number of Participants With Objective Response
Description
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.
Time Frame
Baseline, Day 21 of every even-numbered cycle up to 15 Months
Title
Duration of Response (DR)
Description
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.
Time Frame
Baseline up to Month 15
Title
Progression-Free Survival (PFS)
Description
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.
Time Frame
Baseline up to Month 15
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
L'hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Pfizer Investigational Site
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Pfizer Investigational Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6181128&StudyName=Study%20Of%20Sunitinib%20In%20Combination%20With%20Cisplatin%20And%205-Fluorouracil%20In%20Patients%20With%20Advanced%20Gastric%20Cancer
Description
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Study Of Sunitinib In Combination With Cisplatin And 5-Fluorouracil In Patients With Advanced Gastric Cancer
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