Sorafenib as a Second Line Treatment in Patients With Advanced or Metastatic Gastric Cancer - Full Text View

Sponsored by:	Fudan University
Information provided by:	Fudan University
ClinicalTrials.gov Identifier:	NCT00595985

Purpose

The purpose of this study is to evaluate the efficacy and tolerability of sorafenib as second line treatment in patients with A/MGC

Condition	Intervention	Phase
Gastric Cancer	Drug: sorafenib	Phase II

MedlinePlus related topics: Cancer Stomach Cancer

Drug Information available for: Sorafenib Sorafenib tosylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Phase II Trial of Sorafenib as Second Line Therapy in Patients With Advanced or Metastatic Gastric Cancer

Further study details as provided by Fudan University:

Primary Outcome Measures:

time to progression [ Time Frame: every six weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Toxicity [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	20
Study Start Date:	July 2007
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental administer sorafenib 400mg bid	Drug: sorafenib sorafenib 400mg bid, and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent

Detailed Description:

Up to now, although FU based, cisplatin based and taxane based regimen, and ECF regimen have been suggested as the first line therapy for A/MGC by FDA, there is no standard regimen for patients with A/MGC as second line treatment. Based on the promising results of sorafenib in primary hepatic carcinoma and renal cancer, we design this clinical trial to evaluate the efficacy, time to progression and overall survival of sorafenib for A/MGC patients as a second line treatment.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically confirmed advanced or metastatic adenocarcinoma of the stomach
ECOG performance scale ≤ 2
At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan)
Adequate hepatic, renal, heart, and hematologic functions (platelets＞80 × 109/L, neutrophil＞2.0 × 109/L, serum creatinine ≤ 1.5mg/dl, total bilirubin within upper limit of normal(ULN), and serum transaminase≤2.5×the ULN)

Exclusion Criteria:

Pregnant or lactating women
Concurrent cancer
History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
Neuropathy, brain, or leptomeningeal involvement
Uncontrolled significant comorbid conditions and previous radiotherapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00595985

Contacts

Contact: xiaodong zhu, M.D.

862164175590 ext 1105

xddr001@163.com

Locations

China
Fudan University Cancer Hospital	Recruiting
ShangHai, China, 200032
Contact: xiaodong zhu, M.D. 862164175590 ext 1105 xddr001@163.com
Sub-Investigator: xiaodong zhu, M.D.

Sponsors and Collaborators

Fudan University

Investigators

Principal Investigator:

Jin Li, PhD, M.D.

Fudan University Cancer Hospital

More Information

Responsible Party:	Department of medical oncology, Cancer Hospital, Fuandan University ( Base for drug clinical trials, Fudan University cancer hospital )
Study ID Numbers:	Sorafenib-MGC
Study First Received:	January 7, 2008
Last Updated:	February 26, 2008
ClinicalTrials.gov Identifier:	NCT00595985
Health Authority:	China: Ethics Committee

Keywords provided by Fudan University:

Time to Progression
Toxicity
Overall survival

Response rate
Quality of live
Toxicities

Study placed in the following topic categories:

Stomach Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Stomach Neoplasms

Disease Progression
Gastrointestinal Neoplasms
Stomach cancer
Sorafenib

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009