Study Of Sunitinib With S-1 And Cisplatin For Gastric Cancer - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00553696

Purpose

To assess the maximal tolerated dose (MTD) and overall safety of sunitinib when administered in combination with S-1 and Cisplatin in patients with advanced/metastatic gastric cancer.

Condition	Intervention	Phase
Stomach Neoplasms	Drug: Cisplatin Drug: S-1 Drug: Sunitinib	Phase I

MedlinePlus related topics: Cancer Stomach Cancer

Drug Information available for: Cisplatin Sunitinib Sunitinib malate S 1 (Combination)

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study
Official Title:	A Phase I Study Of Sunitinib In Combination With S-1 And Cisplatin In Patients With Advanced Or Metastatic Gastric Cancer

Further study details as provided by Pfizer:

Primary Outcome Measures:

first cycle dose limiting toxicity (DLT) [ Time Frame: first cycle dose limiting toxicity (DLT) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Pharmacokinetics parameters on Sunitinib, S-1 and Cisplatin during 1-4 cycles. [ Time Frame: during 1-4 cycles ] [ Designated as safety issue: Yes ]
PFS, TTP and ORR throughout the treatment period (12 months) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Safety profile throughout the treatment period (12 months). [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	30
Study Start Date:	November 2007
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: Cisplatin Cisplatin 60 mg/m2 on day 1 of each 28 day cycle Drug: S-1 S-1 80 mg/m2 on days 1-21 of each 28 day cycle Drug: Sunitinib Sunitinib 25 mg, 37.5 mg and 50 mg daily S-1 80 mg/m2 on days 1-21 of each 28 day cycle Cisplatin 60 mg/m2 on day 1 of each 28 day cycle

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically or cytologically confirmed diagnosis of gastric cancer
Chemonaive patients
Adequate organ function

Exclusion Criteria:

Patients who meet the contra-indications of S-1 and Cisplatin.
Prior chemotherapy failure patients

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00553696

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

Japan, Aichi
Pfizer Investigational Site	Recruiting
Nagoya, Aichi, Japan
Japan, Nagano
Pfizer Investigational Site	Recruiting
Saku, Nagano, Japan
Japan, Shizuoka
Pfizer Investigational Site	Recruiting
Suntougun, Shizuoka, Japan

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:	A6181127
Study First Received:	November 2, 2007
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00553696
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Pfizer:

chemotherapy, combination

Study placed in the following topic categories:

Stomach Diseases
Digestive System Diseases
Digestive System Neoplasms
Cisplatin
Sunitinib

Gastrointestinal Diseases
Stomach Neoplasms
Gastrointestinal Neoplasms
Stomach cancer

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Antineoplastic Agents
Growth Substances
Therapeutic Uses

Physiological Effects of Drugs
Growth Inhibitors
Angiogenesis Modulating Agents
Angiogenesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009