Status:
UNKNOWN
Phase II Study of Albumin Bound Paclitaxel With 5-FU and CF as Second Line in Taxanes Naive Advanced Gastric Cancer
Lead Sponsor:
Sun Yat-sen University
Conditions:
Gastric Caner
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2014
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT02229045
Start Date
November 1 2010
End Date
December 1 2014
Last Update
August 29 2014
Active Locations (1)
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1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060