A Study of Pazopanib With CAPEOX in AGC Patients

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Samsung Medical Center
• Treatments: Capecitabine; Oxaliplatin

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 < 1.5 times upper limit of normal (ULN), AST and ALT < 2.5 times ULN, PT (INR), PTT < 1.2 times UNL Serum creatinine less than 1.5 mg/dL or Calculated Ccr at least 50 mL/min, Urine Protein to Creatinine Ratio (UPC) less than 1

• female with Non-childbearing potential

Exclusion Criteria:

• Prior malignancy

• History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have previously-treated CNS metastases, are asymptomatic, and have had no requirement for steroids or anti-seizure medication for 6 months prior to first dose of study drug

• Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including

• Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product

• Presence of uncontrolled infection

• Corrected QT interval (QTc) above 480 msecs using Bazett's formula

• History of any one or more of the following cardiovascular conditions within the past 6 months: Cardiac angioplasty or stenting, Myocardial infarction, Unstable angina, Coronary artery bypass graft surgery, Symptomatic peripheral vascular disease, Class II or higher congestive heart failure

• Poorly controlled hypertension while on antihypertensive agents

• History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months

• Prior major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer

• Evidence of active bleeding or bleeding diathesis

• Hemoptysis within 6 weeks of first dose of study drug

• Any serious and/or unstable preexisting medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures

• Unable or unwilling to discontinue use of prohibited medications listed in the protocol

• Treatment with any of the following anti-cancer therapies;Radiation therapy, surgery or tumor embolization within 14 days prior to the first dose of pazopanib; biologic therapy, immunotherapy, investigational therapy or hormonal therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of pazopanib; No prior chemotherapy except adjuvant chemotherapy (Patients who received adjuvant chemotherapy at least 6 months prior to study entry will be allowed regardless of chemotherapeutic regimen

• Pre-existing grade 2 (or higher) motor or sensory neuropathy by CTCAE v4.0

• Known allergy to study drugs