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

Phase 1

Completed

Brief 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
A	Capecitabine, Cisplatin, Sorafenib	XP+sorafenib
B	Capecitabine, Cisplatin, Sorafenib	XP

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Experienced Dose Limiting Toxicities (DLTs)	28weeks	Number of Participants who Experienced Dose Limiting Toxicities (DLTs)
Progression-free Survival	1 year

Secondary Outcome Measures

Name	Time	Method
Response Rate	6 months	Tumor response was assessed every two cycles by RECIST(v1.0) using the same imaging techniques and methods used at baseline. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.", or similar definition that is accurate and appropriate
Overall Survival	28 months
Toxicity Profile (According to National Cancer Institute Common Terminology Criteria for Adverse Event Version 3.0)	28weeks	Number of patients who experienced toxicity from study treatment to evaluate the safety and tolerability of Capecitabine and cisplatin plus sorafenib