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

• 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: Pfizer
• Information provided by (Responsible Party): Pfizer

Tracking Information

• First Submitted Date: November 8, 2007
• First Posted Date: November 9, 2007
• Results First Submitted Date: December 15, 2010
• Results First Posted Date: January 5, 2011
• Last Update Posted Date: December 19, 2011
• Study Start Date: August 2008
• Actual Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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 ]

Current Secondary Outcome Measures (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 (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: 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
• 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: 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.
• 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

Experimental: A

Interventions:

• Drug: 5-fluorouracil
• Drug: cisplatin
• Drug: sunitinib malate

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 19, 2010): 34
• Original Estimated Enrollment (submitted: November 8, 2007): 30
• Actual Study Completion Date: August 2010
• Actual Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Spain

Administrative Information

• NCT Number: NCT00555672
• Other Study ID Numbers: A6181128
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Pfizer
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: December 2011