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

Phase 2

Terminated

• Conditions: Gastric Cancer
• Interventions: Drug: sorafenib

• Registration Number: NCT00595985
• Lead Sponsor: 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).

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 Timeline

• Study Start: 2007-07
• Study First Submitted: 2008-01-07
• Study First Submitted QC: 2008-01-15
• Study First Posted: 2008-01-16
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Status Verified: 2009-07
• Last Update Submitted: 2009-07-06
• Last Update Posted: 2009-07-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	sorafenib	administer sorafenib 400mg bid until disease progression or intolerable toxicity or patients withdrawal of consent

Primary Outcome Measures

Name	Time	Method
time to progression	every six weeks

Secondary Outcome Measures

Name	Time	Method
toxicity	6 weeks

Trial Locations

Locations (1)

Fudan University Cancer Hospital; 🇨🇳 ShangHai, Shanghai, China