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

NCT ID: NCT00565370

Last Updated: 2020-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2009-12-31

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.

Conditions

Advanced Gastric Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

XP+sorafenib

Group Type: EXPERIMENTAL

Capecitabine, Cisplatin, Sorafenib

Intervention Type: DRUG

Capecitabine ( ) mg/m2 bid D1-D15 Cisplatin 80 mg/m2 D1 Sorafenib ( ) mg bid PO daily every 3 weeks

B

XP

Group Type: PLACEBO_COMPARATOR

Capecitabine, Cisplatin, Sorafenib

Intervention Type: DRUG

Capecitabine ( ) mg/m2 bid D1-D15 Cisplatin 80 mg/m2 D1 Sorafenib ( ) mg bid PO daily every 3 weeks

Interventions

Capecitabine, Cisplatin, Sorafenib

Capecitabine ( ) mg/m2 bid D1-D15 Cisplatin 80 mg/m2 D1 Sorafenib ( ) mg bid PO daily every 3 weeks

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Yoon-Koo Kang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yoon-Koo Kang, MD, PhD

Role: STUDY_CHAIR

Asan Medical Center

Locations

Asan Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

AMC0701

Identifier Type: -

Identifier Source: org_study_id