NCT00555672

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2008

Typical duration for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 9, 2007

Completed
9 months until next milestone

Study Start

First participant enrolled

August 1, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
5 months until next milestone

Results Posted

Study results publicly available

January 5, 2011

Completed
Last Updated

December 19, 2011

Status Verified

December 1, 2011

Enrollment Period

1.3 years

First QC Date

November 8, 2007

Results QC Date

December 15, 2010

Last Update Submit

December 12, 2011

Conditions

Stomach Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With First-cycle Dose Limiting Toxicities (DLTs)

    The incidence of DLTs assessed during the first cycle (21 days).

    Cycle 1 (Baseline to Day 21)

Secondary Outcomes (10)

  • Maximum Observed Plasma Concentration (Cmax)

    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)]

    Day 1 of Cycle 1 (2, 4, 6, 8, 10, and 24 hours postdose)

  • Time to Reach Maximum Observed Plasma Concentration (Tmax)

    Day 1 of Cycle 1 (2, 4, 6, 8, 10, and 24 hours post dose)

  • Steady State Concentration (Css) of 5-Fluorouracil (5-FU)

    Day 1 of Cycle 1 (2, 4, and 6 hours post infusion)

  • Infusion Rate (Zero Order) (R0) of 5-FU

    Day 1 of Cycle 1 (2, 4, and 6 hours post infusion)

  • +5 more secondary outcomes

Study Arms (1)

A

EXPERIMENTAL
Drug: 5-fluorouracilDrug: cisplatinDrug: sunitinib malate

Interventions

5-fluorouracilDRUG

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.

A
cisplatinDRUG

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.

A
sunitinib malateDRUG

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.

A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • prior chemotherapy for stomach cancer in its advanced stage
  • excessive toxicities related to prior therapies
  • pregnant or breastfeeding patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Pfizer Investigational Site

Barcelona, Barcelona, 08003, Spain

Location

Pfizer Investigational Site

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Pfizer Investigational Site

Madrid, Madrid, 28041, Spain

Location

Related Links

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

FluorouracilCisplatinSunitinib

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

UracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsPyrrolesAzolesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2007

First Posted

November 9, 2007

Study Start

August 1, 2008

Primary Completion

December 1, 2009

Study Completion

August 1, 2010

Last Updated

December 19, 2011

Results First Posted

January 5, 2011

Record last verified: 2011-12

Locations

ES(3)