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

December 12, 2011 updated by: Pfizer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08003
        • Pfizer Investigational Site
      • Madrid, Spain, 28041
        • Pfizer Investigational Site
    • Barcelona
      • L'hospitalet de Llobregat, Barcelona, Spain, 08907
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Cycle 1 (Baseline to Day 21)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Observed Plasma Concentration (Cmax)
Time Frame: Day 1 of Cycle 1 (2, 4, 6, 8, 10, and 24 hours post dose)
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).
Day 1 of Cycle 1 (2, 4, 6, 8, 10, and 24 hours postdose)
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).
Day 1 of Cycle 1 (2, 4, 6, 8, 10, and 24 hours post dose)
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).
Day 1 of Cycle 1 (2, 4, and 6 hours post infusion)
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.
Day 1 of Cycle 1 (2, 4, and 6 hours post infusion)
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).
Day 1 of Cycle 1 (2, 4, and 6 hours post infusion)
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).
Day 1 of Cycle 1 (2, 4, and 6 hours post infusion)
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.
Baseline, Day 21 of every even-numbered cycle up to 15 Months
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.
Baseline up to Month 15
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.
Baseline up to Month 15

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

November 8, 2007

First Submitted That Met QC Criteria

November 8, 2007

First Posted (Estimate)

November 9, 2007

Study Record Updates

Last Update Posted (Estimate)

December 19, 2011

Last Update Submitted That Met QC Criteria

December 12, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A6181128

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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