A Study of Pazopanib With CAPEOX in AGC Patients
- Conditions
- Gastric Cancer
- Interventions
- Registration Number
- NCT01130805
- Lead Sponsor
- Samsung Medical Center
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 66
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Pazopanib in combination with capecitabine and oxaliplatin 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
- Primary Outcome Measures
Name Time Method Response rate 6 months after last patient
- Secondary Outcome Measures
Name Time Method Toxicities 6 months Progression free survival (PFS) one year Overall survival (OS) Two years Metabolic response rate by PET-CT 1 month
Trial Locations
- Locations (1)
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of