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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Phase II Trial of Sorafenib as Second Line Therapy in Patients With Advanced or Metastatic Gastric Cancer

Conditions
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Gastric Cancer

Intervention / Treatment
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* Drug: sorafenib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>administer sorafenib 400mg bid until disease progression or intolerable toxicity or patients withdrawal of consent | Drug: sorafenib<br>* sorafenib 400mg bid, and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent<br>* Other names: treatment group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to progression |  | every six weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| toxicity |  | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Time to Progression, Toxicity, Overall survival, Response rate, Quality of live, Toxicities