Capecitabine and Cisplatin (XP)+Sorafenib in Advanced Gastric Cancer (AGC): Sorafenib+XP

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

There is strong scientific rationale for exploring the role of sorafenib with capecitabine and cisplatin (XP) in AGC. XP is a new standard of care in AGC and sorafenib is a novel signal transduction inhibitor that prevents tumor cell proliferation and angiogenesis through blockade of the Raf/MEK/ERK pathway at the level of Raf kinase and the receptor tyrosine kinases VEGF-R2 and PDGFR-beta.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Asan Medical Center
• Treatments: Capecitabine; Cisplatin; Niacinamide; Sorafenib

Criteria

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