A Phase I-II Study of Sorafenib (Nexavar®) in Combination With Capecitabine and Cisplatin (XP) in Patients With Advanced Gastric Cancer
Inclusion Criteria:
- Having given signed written informed consent
- Unresectable advanced gastric adenocarcinoma, initially diagnosed or recurred
- No history of chemotherapy or radiation
- Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST)
- Age 18-75 years
- Estimated life expectancy of more than 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Adequate bone marrow function (absolute neutrophil count > 1,500/µL, platelets >
100,000/µL, hemoglobin > 8g/dl),
- Adequate kidney function (creatinine clearance > 60 ml/min)
- Adequate liver function (bilirubin < 2.0 mg/dL, transaminases levels < 3 times the
upper normal limit [5 times for patients with liver metastasis])
Exclusion Criteria:
- Past or concurrent history of neoplasm other than gastric adenocarcinoma, except for
curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix uteri
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
prior to study treatment start
- Presence of central nervous system metastasis
- Obvious peritoneal seeding or bowel obstruction
- Evidence of serious gastrointestinal bleeding
- Peripheral neuropathy (National Cancer Institute Common Terminology Criteria for
Adverse Event version 3.0 > Grade I)
- History of significant neurologic or psychiatric disorders
- Pregnant or lactating women, women of childbearing potential not employing adequate
contraception
- Other serious illness or medical conditions
- Known allergy to study drugs