Sorafenib as a Second Line Treatment in Patients With Advanced or Metastatic Gastric Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00595985
Recruitment Status : Terminated (low response rate, no evidence of PFS or OS improved.)
First Posted : January 16, 2008
Last Update Posted : July 7, 2009
Information provided by:
Fudan University

Brief Summary:
The purpose of this study is to evaluate the efficacy and tolerability of sorafenib as second line treatment in patients with Advanced or Metastatic Gastric Cancer (A/MGC).

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: sorafenib Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Sorafenib as Second Line Therapy in Patients With Advanced or Metastatic Gastric Cancer
Study Start Date : July 2007
Estimated Primary Completion Date : January 2009
Estimated Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: A
administer sorafenib 400mg bid until disease progression or intolerable toxicity or patients withdrawal of consent
Drug: sorafenib
sorafenib 400mg bid, and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
Other Name: treatment group

Primary Outcome Measures :
  1. time to progression [ Time Frame: every six weeks ]

Secondary Outcome Measures :
  1. toxicity [ Time Frame: 6 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)
    • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00595985

China, Shanghai
Fudan University Cancer Hospital
ShangHai, Shanghai, China, 200032
Sponsors and Collaborators
Fudan University
Principal Investigator: Jin Li, PhD, M.D. Fudan University

Responsible Party: Base for drug clinical trials, Fudan University cancer hospital, Department of medical oncology, Cancer Hospital, Fuandan University Identifier: NCT00595985     History of Changes
Other Study ID Numbers: Sorafenib-MGC
First Posted: January 16, 2008    Key Record Dates
Last Update Posted: July 7, 2009
Last Verified: July 2009

Keywords provided by Fudan University:
Time to Progression
Overall survival
Response rate
Quality of live

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs