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A Study of Pazopanib With CAPEOX in AGC Patients

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Descriptive Information
Brief Title † A Study of Pazopanib With CAPEOX in AGC Patients
Official Title † A Phase II Study of Pazopanib in Combination With Capecitabine and Oxaliplatin (CAPEOX) in Patients With Advanced Gastric Cancer
Brief Summary In order to improve survival of metastatic gastric cancer patients, we plan to to conduct a phase II trial of CapeOx with 800 mg once-daily pazopanib as a first-line chemotherapy in metastatic gastric cancer patients.
Detailed Description Despite improvements in the early diagnosis of gastric cancer, many patients present with inoperable disease and an effective, novel combination treatment is urgently needed for these patients population. A recent meta-analysis demonstrated that chemotherapy improves survival for patients with advanced gastric cancer compared with best supportive care alone [hazard ratio (HR) 0.39, 95% confidence interval (CI) 0.28-0.52] and that combination chemotherapy is superior to monotherapy (HR 0.83, 95% CI 0.74-0.93) (Wagner et al., 2006). For advanced gastric cancer, 5-FU in combination with cisplatin (FP regimen) is commonly used reference regimen, which are successfully replaced by capecitabine and oxaliplatin in recent phase III trial (Cunningham et al., 2008; Okines et al., 2009). In phase II trial, CAPEOX (capecitabine combined with oxaliplatin) regimen also showed promising activity for the metastatic gastric cancer (Park et al., 2006; Park et al., 2008). In order to improve survival of metastatic gastric cancer patients, various clinical trials incorporated novel molecularly targeted agent in combination with the reference arm.
Study Phase Phase 2
Study Type † Interventional
Study Design † Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary Outcome Measure † Response rate
Secondary Outcome Measure † Progression free survival (PFS)
Condition † Gastric Cancer
Intervention † DrugPazopanib in combination with capecitabine and oxaliplatin
Study Arms / Comparison Groups Pazopanib in combination with capecitabine and oxaliplatin Capecitabine 850 mg/m2 bid on day 1-14, Oxaliplatin 130 mg/m2 IV on day 1 and Pazopanib 800 mg once in a day on day 1-21, every 3 weeks
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 66
Start Date † December 2010
Completion Date December 2015
Primary Completion Date June 2015
Eligibility Criteria † Inclusion Criteria: - Subjects who provide written informed consent - Age over 18 years - Histologically proven unresectable gastric cancer - ECOG performance status of 0-2 - At least one uni-dimensionally measurable lesion by RECIST criteria ver 1.1 - Adequate organ system function absolute neutrophil count > 1,500/µL, platelets > 100,000/µL, hemoglobin > 9g/dl Total bilirubin
Gender Both
Ages 18 Years - N/A
Accepts Healthy Volunteers No
Contacts ††
Location Countries † Korea, Republic of
Administrative Information
NCT ID † NCT01130805
Organization ID 2010-03-068
Secondary IDs ††
Responsible Party Principal Investigator
Study Sponsor † Samsung Medical Center
Collaborators ††
Investigators † Principal Investigator: Joon Oh Park, M.D., Ph.D., Samsung Medical Center
Information Provided By
Verification Date April 2016
First Received Date † May 25, 2010
Last Updated Date April 13, 2016
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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