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

Asan Medical Center1 site in 1 country195 target enrollmentAugust 2010

ConditionsMalignant Neoplasm of Stomach Effects of Chemotherapy

InterventionsCapecitabine/Cisplatin Capecitabine/Cisplatin + Sorafenib

DrugsCapecitabine/Cisplatin + Sorafenib Capecitabine/Cisplatin

Overview

Phase: Phase 2
Intervention: Capecitabine/Cisplatin
Conditions: Malignant Neoplasm of Stomach
Sponsor: Asan Medical Center
Enrollment: 195
Locations: 1
Primary Endpoint: Progression-free survival
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study investigates the efficacy and safety profiles of sorafenib in combination of capecitabine and cisplatin, one of standard chemotherapy regimens in patients with advanced gastric cancer.

Registry

clinicaltrials.gov

Start Date

August 2010

End Date

August 2014

Last Updated

6 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Asan Medical Center

Responsible Party

Principal Investigator

Yoon-Koo Kang

Professor

Asan Medical Center

Eligibility Criteria

Inclusion Criteria

•Histological or cytological documentation of gastric adenocarcinoma or gastroesophageal junction adenocarcinoma.;
•Metastatic gastric adenocarcinoma or metastatic gastroesophageal junction adenocarcinoma, initially diagnosed or recurrent.
•Measurable disease according to Response Evaluation Criteria in Solid Tumors
•ECOG Performance Status of 0 or 1
•Life expectancy of at least 3 months
•Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements:
•Hemoglobin ≥ 9.0 g / dl
•Absolute neutrophil count (ANC) ≥1,500 / mm3
•Platelet count ≥ 100,000 / mm3
•Total bilirubin \< 1.5 x upper limit of normal

Exclusion Criteria

•Patients with local-regional gastric or gastroesophageal adenocarcinoma (no para-aortic nodes or visceral structure-invading primary \[T4\]) who can potentially become candidates for surgery with curative intent following systemic therapy
•History of cardiac disease:
•Congestive heart failure \>NYHA class 2; unstable angina (angina symptoms present at rest), new-onset angina (began within last three months prior to randomization) or myocardial infarction within six months prior to randomization;
•Ventricular arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted);
•Uncontrolled hypertension (systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 90 mmHg) despite optimal medical management
•Past or concurrent history of neoplasm \< 5 years prior to start of study treatment other than gastric adenocarcinoma or gastroesophageal junction adenocarcinoma, except for curatively treated non-melanoma skin cancer, in situ carcinoma of the cervix uteri or superficial bladder tumors \[Ta noninvasive tumor (Ta), carcinoma in situ (Tis) and T1 (tumor invades lamina propria)\]
•Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to randomization
•Evidence of gastrointestinal perforation or bowel obstruction during the screening period
•Evidence or history of bleeding diathesis or coagulopathy
•Non-healing wound, ulcer, or bone fracture