chemo-refractory gastric cancer
Conditions
Interventions
Ramucirumab: 8 mg/kg, day1, biweekly Irinotecan: 150 mg/m2, day1, biweekly
Sponsors
Osaka University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histopathologically confirmed adenocarcinoma of gastric or gastroesophageal junction (GEJ) with inoperable, locally advanced or metastatic disease, not amenable to curative therapy. 2. Documented objective radiographic or clinical disease progression after chemotherapy. 3. Measurable disease or non-measurable but evaluable disease, according to RECIST criteria version 1.1. 4. Age >= 20 years. 5. ECOG PS of 0 or 1. 6. Sufficient oral intake. 7. Adequate organ function. 8. Life expectancy of at leaset 3 months. 9. Written informed consent obtained prior to any study specific procedures.
Exclusion criteria
Exclusion criteria: 1. History of another malignancy which could affect compliance with the protocol or interpretation of result of the study. 2. Previous systemic chemotherapy with irinotecan. 3. Uncontrolled arterial hypertension (e.g. >= 150 / >= 90 mmHg despite standard medical management) 4. Active infection requiring intravenous antibiotics at entry. 5. Serious illness or medical conditions. 6. Uncontrolled diarrhea which disrupt daily life despite fully medical management. 7. History of severe allergy or hypersensitivity for any drugs. 8. Moderate or large ascites or pleural effusion. 9. Chronic daily treatment with oral cortisteroid treatment. 10. Evidence of psychological disorder. 11. Symptomatic evidence of known central nervous system metastases or carcinomatous meningitis. 12. Daily treatment with atazanavir sulfate. 13. Pregnant or breastfeeding, or unwilling to practice contraception during the study. 14. Known acute or choric-active infection with HBV or HCV. 15. Any condition that suggest that the patient is, in the investigator's opinion, not an appropriate candidate for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DLTs | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival, time to treatment failure, response rate, disease control rate, adverse events, relative dose intensity | — |
Countries
Japan
Contacts
Public ContactDaisuke Sakai
Osaka Univesity Department of Frontier Science for Cancer and Chemotherapy
Outcome results
None listed