A Phase II study of Ramucirumab beyond disease progression in combination with Irinotecan after failure of weekly Paclitaxel plus Ramucirumab in advanced gastric cancer patients previously treated with fluoropyrimidine and platinum
- Conditions
- Gastric cancer
- Registration Number
- JPRN-UMIN000022956
- Lead Sponsor
- The University of Tokyo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 53
Not provided
1)with active double cancers excluding carcinoma in situ 2)with pleural fluid, ascites or pericardial effusion that requires drainage 3)with ileus or constipation (>=grade 3) 4)with a histroy of uncontrollable hypertension or acute coronary syndrome in 6 months 5)with active gastrointestinal bleeding in 14 days 6)with severe or uncotrollable complications such as diabetes mellitus, bowel obstruction, jaundice, liver dysfunction, psychological illness and severe infectious disease. 7)with active hepatitis B or C 8)with HIV infection 9)with a history of interstitial pneumonia, pulmonary fibrosis or irradiation pneumonitis 10)with hemorrhagic diathesis or blood coagulation disorder 11)within 28 days after open abdominal or chest surgery or with unrecoverd surgical wounds 12)pregnant and/or nursing women or men who wish to have children in future 13)judged to be unfit to participate in this study by investigater
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression free survival
- Secondary Outcome Measures
Name Time Method Achievement ratio of second registration Treatment continuation rate at eight weeks after second registration Response rate Overall survival Safety Quality of life