Phase II Study of Albumin Bound Paclitaxel With 5-FU and CF as Second Line in Taxanes Naive Advanced Gastric Cancer
NCT ID: NCT02229045
Last Updated: 2014-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
37 participants
INTERVENTIONAL
2010-11-30
2014-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Albumin Bound Paclitaxel With 5-FU/CF
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.
Albumin Bound Paclitaxel
Albumin Bound Paclitaxel 150 mg/m2 (on day 1), every 2 weeks until disease progress or intolerable toxicity.
5-FU
5-FU 400 mg/m2 iv d1, 2.4g/ m2 civ,d1-d3 every 2 weeks until disease progress or intolerable toxicity.
Interventions
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Albumin Bound Paclitaxel
Albumin Bound Paclitaxel 150 mg/m2 (on day 1), every 2 weeks until disease progress or intolerable toxicity.
5-FU
5-FU 400 mg/m2 iv d1, 2.4g/ m2 civ,d1-d3 every 2 weeks until disease progress or intolerable toxicity.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Sun Yat-sen University
OTHER
Responsible Party
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Ruihua Xu
Professor of Medical Oncology,Vice-president of Sun Yat-sen University Cancer Center
Principal Investigators
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Ruihua Xu, PhD,MD
Role: PRINCIPAL_INVESTIGATOR
Sun Yat-sen University
Locations
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Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Ruihua Xu, Ph D,MD
Role: primary
Dongsheng Zhang, Ph D,MD
Role: backup
Other Identifiers
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ABI-FU
Identifier Type: -
Identifier Source: org_study_id