Phase II Study of Albumin Bound Paclitaxel With 5-FU and CF as Second Line in Taxanes Naive Advanced Gastric Cancer
Conditions
Gastric Caner
Conditions: Keywords
gastric caner, Albumin Bound Paclitaxel, 5-FU/CF, taxanes naive
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Albumin Bound Paclitaxel Type: Drug
Name: 5-FU Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Location
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Status: Recruiting
Contact: Ruihua Xu, Ph D,MD - 862087343228
Start Date
November 2010
Completion Date
December 2014
Sponsors
Sun Yat-sen University
Source
Sun Yat-sen University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page