A phase II study of nab-Paclitaxel therapy in reductive dose for patients with advanced/recurrent gastric cancer after prior treatments including fluoropyrimidine (OGSG 1302)
- Conditions
- Gastric Cancer
- Registration Number
- JPRN-UMIN000012701
- Lead Sponsor
- Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG)
- Brief Summary
The response rate (RR) was 3.1% [95% confidence interval (CI), 0-16.2%], which did not reach the protocol-specified threshold (p=0.96). disease-control rate (DCR) was 37.5% (95% CI, 21.1-56.3%). Median overall survival (OS) and progression-free survival (PFS) were 6.3 (95% CI, 4.4-14.2) and 2.2 (95% CI, 1.8-3.1) months, respectively. Relative dose intensity (RDI) was 97.8%. Twenty (62.5%) patients received subsequent chemotherapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 33
Not provided
1)with a history of severe allergy against medicine 2)with infectious disease and febrile condition (over 38 centigrade) 3)with severe diseases: interstitial pneumonitis/pulmonary fibrosis, uncontrolled DM, renal failure, and/or liver failure 4)with uncontrollable diarrhea (more than 4 times a day) 5)with a history or present heart diseases (congestive heart failure, cardiac infarction/ischemic heart disease, arrhythmia, valve dysfunction) 6)with active double cancers excluding carcinoma in situ and/or prior cancer cured with longer than 5 year interval period 7)with peripheral nerve disorder severer than grade 2 8)patients who are suspected incompletion of regimen due to psychological disease 9) pregnant or nursing female or male expecting pregnancy of partner 10) with brain metastasis 11) with HBs antigen+, and/or HCV-antibody+ 12) Any other patients whom the physician in charge of the study judges to be unsuitable
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method