Clinical trial NCT00565370: Capecitabine and Cisplatin (XP)+Sorafenib in Advanced Gastric Cancer (AGC): Sorafenib+XP
Official title: A Phase I-II Study of Sorafenib (Nexavar®) in Combination With Capecitabine and Cisplatin (XP) in Patients With Advanced Gastric Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Advanced Gastric Cancer
Keywords: Gastric cancer
capecitabine
cisplatin
sorafenib
phase I
phase II
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2007-11-29
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs)
timeFrame: 28weeks
measure: Progression-free Survival
timeFrame: 1 year
Secondary outcomes:
measure: Response Rate
timeFrame: 6 months
measure: Overall Survival
timeFrame: 28 months
measure: Toxicity Profile (According to National Cancer Institute Common Terminology Criteria for Adverse Event Version 3.0)
timeFrame: 28weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Yoon-Koo Kang, MD, PhD
role: STUDY_CHAIR
References: