Gastric Caner
Conditions
Keywords
gastric caner, Albumin Bound Paclitaxel, 5-FU/CF, taxanes naive
Brief summary
The purpose of this study is to evaluate the effectiveness and safety of albumin bound paclitaxel plus 5-FU and as second-line therapy in the treatment of taxanes naive patients with advanced gastric cancer.
Interventions
Albumin Bound Paclitaxel 150 mg/m2 (on day 1), every 2 weeks until disease progress or intolerable toxicity.
DRUG5-FU
5-FU 400 mg/m2 iv d1, 2.4g/ m2 civ,d1-d3 every 2 weeks until disease progress or intolerable toxicity.
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed adenocarcinoma of the stomach with inoperable locally advanced or recurrent and/or metastatic disease. * Male or female. * Age 18 -75. * Previous one line of non-taxane chemotherapy for advanced/metastatic disease. * Measurable disease, according to the Response Evaluation Criteria in Solid Tumours(RECIST) * ECOG Performance status 0, 1 or 2 * Haematological, Biochemical and Organ Function: Neutrophil count \>2.0 × 10 9/L, platelet count \> 100 ×10 9/L. Serum bilirubin\< 1.5 × upper limit of normal (ULN); or, AST or ALT \< 2.5 × ULN (or \< 5 × ULN in patients with liver metastases); or, alkaline phosphatase\< 2.5 × ULN (or \> 5 × ULN in patients with liver metastases,Creatinine clearance \> 60 mL/min. * Signed informed consent.
Exclusion criteria
* No prior chemotherapy for gastric cancer. * Received any investigational drug treatment within 30 days of start of study treatment. * Patients with active gastrointestinal bleeding. * Neurological toxicity ≥ grade 2 NCI-CTCAE. * Other malignancy within the last 5 years, except for carcinoma in situ of the cervix, or basal cell carcinoma. * History or clinical evidence of brain metastases. * Serious uncontrolled systemic intercurrent illness, e.g. infections or poorly controlled diabetes. * Pregnancy women. * Subjects with reproductive potential not willing to use an effective method of contraception. * Patients with known active infection with HIV. * Known hypersensitivity to any of the study drugs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS(Progression-free survival ) | 80% PFS events,, an expected average of 10 months | The PFS was calculated from the initiation of chemotherapy to the date of disease progression or death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OS (Overall survival ) | OS follow-up period: 18 months or 80% OS events, whichever occurs first | Overall survival was measured from the initiation of chemotherapy to the date of the last follow-up or death. |
Other
| Measure | Time frame | Description |
|---|---|---|
| ORR (Overall tumor response) | 80% PFS events, an expected average of 10 months | Overall tumor response: This is defined as the occurrence of either a confirmed complete (CR) or a partial (PR) best overall response as determined by the RECIST criteria from confirmed radiographic evaluations of target and non-target lesions. |
Countries
China
Contacts
Primary ContactRuihua Xu, PhD,MD
Backup ContactDongsheng Zhang, PhD,MD
Outcome results
None listed