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

Advanced Gastric Cancer Clinical Trial

Official title:

A Phase I-II Study of Sorafenib (Nexavar®) in Combination With Capecitabine and Cisplatin (XP) in Patients With Advanced Gastric Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00565370
• Other study ID #: AMC0701
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: November 2007
• Est. completion date: December 2009

Study information

• Verified date: January 2020
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

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

Related Conditions & MeSH terms

• Advanced Gastric Cancer
• Stomach Neoplasms

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Experienced Dose Limiting Toxicities (DLTs)	Number of Participants who Experienced Dose Limiting Toxicities (DLTs)	28weeks
Primary	Progression-free Survival		1 year
Secondary	Response Rate	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	6 months
Secondary	Overall Survival		28 months
Secondary	Toxicity Profile (According to National Cancer Institute Common Terminology Criteria for Adverse Event Version 3.0)	Number of patients who experienced toxicity from study treatment to evaluate the safety and tolerability of Capecitabine and cisplatin plus sorafenib	28weeks