Phase II Study of Albumin Bound Paclitaxel With 5-FU and CF as Second Line in Taxanes Naive Advanced Gastric Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Phase II Study of Albumin Bound Paclitaxel With 5-FU and CF as Second Line in Taxanes Naive Advanced Gastric Cancer

Conditions
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Gastric Caner

Intervention / Treatment
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* Drug: Albumin Bound Paclitaxel
* Drug: 5-FU


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Albumin Bound Paclitaxel With 5-FU/CF<br>Albumin Bound Paclitaxel 150 mg/m2 (on day 1),5FU 400 mg/m2 iv d1, 2.4g/ m2 civ,d1-d3 every 2 weeks until disease progress or intolerable toxicity. | Drug: Albumin Bound Paclitaxel<br>* Albumin Bound Paclitaxel 150 mg/m2 (on day 1), every 2 weeks until disease progress or intolerable toxicity.<br>* Other names: Abraxane;Drug: 5-FU<br>* 5-FU 400 mg/m2 iv d1, 2.4g/ m2 civ,d1-d3 every 2 weeks until disease progress or intolerable toxicity.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS(Progression-free survival ) | The PFS was calculated from the initiation of chemotherapy to the date of disease progression or death | 80% PFS events,, an expected average of 10 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OS (Overall survival ) | Overall survival was measured from the initiation of chemotherapy to the date of the last follow-up or death. | OS follow-up period: 18 months or 80% OS events, whichever occurs first | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastric caner, Albumin Bound Paclitaxel, 5-FU/CF, taxanes naive