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

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00555672

Purpose

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.

Condition	Intervention	Phase
Stomach Neoplasms	Drug: 5-fluorouracil Drug: cisplatin Drug: sunitinib malate	Phase I

MedlinePlus related topics: Cancer Stomach Cancer

Drug Information available for: Cisplatin Sunitinib Sunitinib malate Fluorouracil Malic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase I Study Of Sunitinib Malate In Combination With Cisplatin And 5-Fluorouracil In Patients With Advanced Gastric Cancer

Further study details as provided by Pfizer:

Primary Outcome Measures:

determination of maximum tolerated dose [ Time Frame: 10 months ] [ Designated as safety issue: Yes ]
determination of the safety profile of the combination [ Time Frame: 10 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

pharmacokinetic evaluation [ Time Frame: 10 months ] [ Designated as safety issue: No ]
anti-tumor activity [ Time Frame: 15 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	September 2008
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: 5-fluorouracil 5- fluorouracil is given as a 12 hour continuous infusion at 800mg/m2 for 5 consecutive days of a 21 day chemotherapy cycle. Drug: cisplatin Cisplatin is given 75mg/m2 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.

Arms

Assigned Interventions

A: Experimental

Drug: 5-fluorouracil

5- fluorouracil is given as a 12 hour continuous infusion at 800mg/m2 for 5 consecutive days of a 21 day chemotherapy cycle.

Drug: cisplatin

Cisplatin is given 75mg/m2 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00555672

Contacts

Contact: Pfizer Oncology Clinical Trial Information Service	1-877-369-9753	PfizerCancerTrials@emergingmed.com
Contact: Pfizer CT.gov Call Center	1-800-718-1021

Locations

Spain
Pfizer Investigational Site	Recruiting
BARCELONA, Spain, 08003
Pfizer Investigational Site	Recruiting
MADRID, Spain, 28041
Spain, BARCELONA
Pfizer Investigational Site	Recruiting
L'HOSPITALET DE LLOBREGAT, BARCELONA, Spain, 08907

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A6181128
Study First Received:	November 8, 2007
Last Updated:	January 2, 2009
ClinicalTrials.gov Identifier:	NCT00555672
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Stomach Diseases
Digestive System Diseases
Digestive System Neoplasms
Cisplatin
Sunitinib

Gastrointestinal Diseases
Fluorouracil
Stomach Neoplasms
Gastrointestinal Neoplasms
Stomach cancer

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Immunosuppressive Agents

Angiogenesis Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents

ClinicalTrials.gov processed this record on January 15, 2009