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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00555672
First received: November 8, 2007
Last updated: December 12, 2011
Last verified: December 2011

November 8, 2007
December 12, 2011
August 2008
December 2009   (final data collection date for primary outcome measure)
Number of Participants With First-cycle Dose Limiting Toxicities (DLTs) [ Time Frame: Cycle 1 (Baseline to Day 21) ] [ Designated as safety issue: Yes ]
The incidence of DLTs assessed during the first cycle (21 days).
  • determination of maximum tolerated dose [ Time Frame: 10 months ]
  • determination of the safety profile of the combination [ Time Frame: 10 months ]
Complete list of historical versions of study NCT00555672 on ClinicalTrials.gov Archive Site
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Day 1 of Cycle 1 (2, 4, 6, 8, 10, and 24 hours post dose) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
  • pharmacokinetic evaluation [ Time Frame: 10 months ]
  • anti-tumor activity [ Time Frame: 15 months ]
Not Provided
Not Provided
 
Study Of Sunitinib In Combination With Cisplatin And 5-Fluorouracil In Patients With Advanced Gastric Cancer
A Phase I Study Of Sunitinib Malate In Combination With Cisplatin And 5-Fluorouracil In Patients With Advanced Gastric Cancer

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Stomach Neoplasms
  • 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.
Experimental: A
Interventions:
  • Drug: 5-fluorouracil
  • Drug: cisplatin
  • Drug: sunitinib malate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34
August 2010
December 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00555672
A6181128
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2011

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