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

Sun Yat-sen University37 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Gastric Caner

Interventions

Albumin Bound PaclitaxelDRUG

Albumin Bound Paclitaxel 150 mg/m2 (on day 1), every 2 weeks until disease progress or intolerable toxicity.

5-FUDRUG

5-FU 400 mg/m2 iv d1, 2.4g/ m2 civ,d1-d3 every 2 weeks until disease progress or intolerable toxicity.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

RECRUITING

Outcomes

Primary Outcomes

PFS(Progression-free survival )

The PFS was calculated from the initiation of chemotherapy to the date of disease progression or death

Time frame: 80% PFS events,, an expected average of 10 months

Secondary Outcomes

OS (Overall survival )

Overall survival was measured from the initiation of chemotherapy to the date of the last follow-up or death.

Time frame: OS follow-up period: 18 months or 80% OS events, whichever occurs first

Central Contacts

Ruihua Xu, PhD,MD

CONTACT

862087343228 xurh@sysucc.org.cn

Dongsheng Zhang, PhD,MD

CONTACT

862087343795 zhangdsh@sysucc.org.cn

Data from ClinicalTrials.gov

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