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Trial record 1 of 1 for:    NCT00555672
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Study Of Sunitinib In Combination With Cisplatin And 5-Fluorouracil In Patients With Advanced Gastric Cancer

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ClinicalTrials.gov Identifier: NCT00555672
Recruitment Status : Completed
First Posted : November 9, 2007
Results First Posted : January 5, 2011
Last Update Posted : December 19, 2011
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE November 8, 2007
First Posted Date  ICMJE November 9, 2007
Results First Submitted Date  ICMJE December 15, 2010
Results First Posted Date  ICMJE January 5, 2011
Last Update Posted Date December 19, 2011
Study Start Date  ICMJE August 2008
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 15, 2010)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: November 8, 2007)
  • determination of maximum tolerated dose [ Time Frame: 10 months ]
  • determination of the safety profile of the combination [ Time Frame: 10 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 28, 2011)
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 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)] [ Time Frame: Day 1 of Cycle 1 (2, 4, 6, 8, 10, and 24 hours postdose) ]
    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) [ Time Frame: Day 1 of Cycle 1 (2, 4, 6, 8, 10, and 24 hours post dose) ]
    Tmax is the time to first occurrence of maximum observed plasma concentration (Cmax).
  • Steady State Concentration (Css) of 5-Fluorouracil (5-FU) [ Time Frame: Day 1 of Cycle 1 (2, 4, and 6 hours post infusion) ]
    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 [ Time Frame: Day 1 of Cycle 1 (2, 4, and 6 hours post infusion) ]
    Infusion rate of 5-FU equals total dose divided by infusion time.
  • Clearance (CLss) of 5-FU [ Time Frame: Day 1 of Cycle 1 (2, 4, and 6 hours post infusion) ]
    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 [ Time Frame: Day 1 of Cycle 1 (2, 4, and 6 hours post infusion) ]
    Area under the plasma concentration versus time curve from time 2 to 6 hours postdose (2-6).
  • Number of Participants With Objective Response [ Time Frame: Baseline, Day 21 of every even-numbered cycle up to 15 Months ]
    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 Frame: Baseline up to Month 15 ]
    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) [ Time Frame: Baseline up to Month 15 ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 8, 2007)
  • pharmacokinetic evaluation [ Time Frame: 10 months ]
  • anti-tumor activity [ Time Frame: 15 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Of Sunitinib In Combination With Cisplatin And 5-Fluorouracil In Patients With Advanced Gastric Cancer
Official Title  ICMJE A Phase I Study Of Sunitinib Malate In Combination With Cisplatin And 5-Fluorouracil In Patients With Advanced Gastric Cancer
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Stomach Neoplasms
Intervention  ICMJE
  • 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.
  • Drug: 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.
  • Drug: 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.
Study Arms  ICMJE Experimental: A
Interventions:
  • Drug: 5-fluorouracil
  • Drug: cisplatin
  • Drug: sunitinib malate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 19, 2010)
34
Original Estimated Enrollment  ICMJE
 (submitted: November 8, 2007)
30
Actual Study Completion Date  ICMJE August 2010
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00555672
Other Study ID Numbers  ICMJE A6181128
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP