Phase I/II XP+Sorafenib in AGC

This study is currently recruiting participants.

Verified by Asan Medical Center, November 2007

Sponsors and Collaborators:	Asan Medical Center Asian Stomach cancer Investigator Association will join in the phase II portion
Information provided by:	Asan Medical Center
ClinicalTrials.gov Identifier:	NCT00565370

Purpose

There is strong scientific rationale for exploring the role of sorafenib with capecitabine and cisplatin (XP) in AGC. XP is a new standard of care in AGC and sorafenib is a novel signal transduction inhibitor that prevents tumor cell proliferation and angiogenesis through blockade of the Raf/MEK/ERK pathway at the level of Raf kinase and the receptor tyrosine kinases VEGF-R2 and PDGFR-beta.

Condition	Intervention	Phase
Advanced Gastric Cancer	Drug: Capecitabine, Cisplatin, Sorafenib	Phase I Phase II

MedlinePlus related topics: Cancer Stomach Cancer

Drug Information available for: Cisplatin Capecitabine Sorafenib Sorafenib tosylate

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-II Study of Sorafenib (Nexavar®) in Combination With Capecitabine and Cisplatin (XP) in Patients With Advanced Gastric Cancer

Further study details as provided by Asan Medical Center:

Estimated Enrollment:	52
Study Start Date:	November 2007

Arms	Assigned Interventions
A: Experimental XP+sorafenib	Drug: Capecitabine, Cisplatin, Sorafenib Capecitabine ( ) mg/m2 bid D1-D15 Cisplatin 80 mg/m2 D1 Sorafenib ( ) mg bid PO daily every 3 weeks

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Having given signed written informed consent
Unresectable advanced gastric adenocarcinoma, initially diagnosed or recurred
No history of chemotherapy or radiation
Measurable disease according to RECIST
Age 18-75 years
Estimated life expectancy of more than 3 months
ECOG performance status 0-2
Adequate bone marrow function (absolute neutrophil count > 1,500/µL, platelets > 100,000/µL, Hb > 8g/dl),
Adequate kidney function (Ccr > 60 ml/min)
Adequate liver function (bilirubin < 2.0 mg/dL, transaminases levels < 3 times the upper normal limit [5 times for patients with liver metastasis])

Exclusion Criteria:

Past or concurrent history of neoplasm other than gastric adenocarcinoma, except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix uteri
Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start
Presence of CNS metastasis
Obvious peritoneal seeding or bowel obstruction
Evidence of serious gastrointestinal bleeding
Peripheral neuropathy (NCI CTC > Grade I)
History of significant neurologic or psychiatric disorders
Pregnant or lactating women, women of childbearing potential not employing adequate contraception
Other serious illness or medical conditions
Known allergy to study drugs

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00565370

Contacts

Contact: Yun-Mi Seo, BS	82-2-3010-7181	yms@amc.seoul.kr
Contact: Jae-Lyun Lee, MD, PhD	82-2-3010-5977	jaelyun@amc.seoul.kr

Locations

Korea, Republic of
Asan Medical Center	Recruiting
Seoul, Korea, Republic of, 138-736

Sponsors and Collaborators

Asan Medical Center

Asian Stomach cancer Investigator Association will join in the phase II portion

Investigators

Study Chair:

Yoon-Koo Kang, MD, PhD

Asan Medical Center

More Information

Study ID Numbers:	AMC-ONCOGI-0701
Study First Received:	November 28, 2007
Last Updated:	November 28, 2007
ClinicalTrials.gov Identifier:	NCT00565370
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Asan Medical Center:

Gastric cancer
capecitabine
cisplatin

sorafenib
phase I
phase II

Study placed in the following topic categories:

Capecitabine
Stomach Diseases
Digestive System Diseases
Digestive System Neoplasms
Cisplatin

Gastrointestinal Diseases
Stomach Neoplasms
Gastrointestinal Neoplasms
Stomach cancer
Sorafenib

Additional relevant MeSH terms:

Antimetabolites
Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Radiation-Sensitizing Agents

Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009