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

Asan Medical Center

Status and phase: Completed; Phase 2; Phase 1

Conditions: Advanced Gastric Cancer

Treatments: Drug: Capecitabine, Cisplatin, Sorafenib

Study type: Interventional

Funder types: Other

Identifiers

NCT00565370

AMC0701

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 2 patient groups, including a placebo group

A

Experimental group

Description:

XP+sorafenib

Treatment:

Drug: Capecitabine, Cisplatin, Sorafenib

B

Placebo Comparator group

Description:

XP

Treatment:

Drug: Capecitabine, Cisplatin, Sorafenib