gastric cancer
Conditions
Interventions
Ramucirumab: 8mg/kg(i.v.) administration at day 1,15,29 Nab-Paclitaxel: 180-260mg/m2 administration at day 1,22 (dose escalation: level1= 180mg/m2,level 2 = 220mg/m2, level 3 = 260mg/m2)
Sponsors
Digestive Disease Support Organization (DDSO)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age over 20 years old and under 75 years old 2.Histological confirmed unresectable advanced or recurrent gastric cancer 3. Refractory to fluoropyrimidine and platinum containing chemotherapy. Within 4 months after last chemotherapy. 4. ECOG performance status 0-1 5. Cases with measurable lesion 6. No adverse event over Grade2(NCI-CTCAE, Ver 4.02) attributable to prior surgery or chemotherapy 7. Peripheral sensory neuropathy<=Grade1 8. No prior therapy with paclitaxel 9. Cases with adequately maintained organ functions and fullfilling the following conditions within 2 weeks before registration. a)leukocyte count <= 12000/mm3 b)neutrophil count >= 2000/ mm3 c)hemoglobin level >= 9.0g/ dL d)platelet count >= 100,000/mm3 e)AST and ALT <=100IU/L, or AST and ALT <=200IU/L with liver metastases f)total bilirbin < 1.5mg/dL g)ALP<=2.5xULN in each institution h)serum creatinine <=1.5xULN in each institution or creatinine clearance=>50ml/min i)PT-INR<1.5 or PT<1.5xULN in each institution j)APTT<=1.5xULN in each institution k)Urinary protein is<1+ on dipstick or routine urinalysis. If urine dipstick or routine analysis indicates proteinuria more than 2+, then a 24-hour must demonstrate<1000 mg of protein in 24 hours. 10.Cases expected to survive for 90 days or more 11.Written informed consent
Exclusion criteria
Exclusion criteria: 1. History of severe drug allergy or hypersensitivity 2. Active or uncontrolled clinically serious infection 3. Evidence of any other serious disease 4. Synchronous or metachronous malignancies other than carcinoma in situ or mucosal carcinoma 5. History of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism (venous port or catheter thrombosis or superficial venous thrombosis are not considered significant) during the 3 months prior to randomization. 6. Receiving therapeutic anticoagulation with warfarin, low-molecular weight heparin or similar agents. 7. Receiving chronic therapy with nonsteroidal anti-inflammatory agents or other anti-platelet agents. Aspirin use at doses up to 325 mg/day is permitted. 8. Significant bleeding disorders, vasculitis, or had a significant bleeding episode from the gastrointestinal tract within 3 months prior to study entry. 9. History of gastrointestinal perforation and/or fistulae within 6 months prior to randomization. 10. Symptomatic congestive heart failure (New York Heart Association II-IV) or symptomatic or poorly controlled cardiac arrhythmia. 11. Any arterial thrombotic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 6 months prior to randomization. 12. Uncontrolled arterial hypertension >150/>90mmHg despite standard medical management 13. Serious or non healing wound or peptic ulcer or bone fracture within 28 days prior to randomization 14. Bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection, Crohns disease, ulcerative colitis, or chronic diarrhea 15.Massive ascites, pleural effusion, or cardiac effusion 16.The patient is pregnant or breastfeeding 17. Judged inappropriate by the investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I part primary endpoint: The frequency of Dose limiting toxicity(DLT) Phase II part primary endpoint: Overall response rate | — |
Countries
Japan
Contacts
Public ContactJun Kinoshita
Digestive Disease Support Organization (DDSO) Gastroenterologic surgery
Outcome results
None listed