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

• Status: Terminated
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Treatments: Niacinamide; Sorafenib

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)

• 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