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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

Information source: Sun Yat-sen University
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Gastric Caner

Intervention: Albumin Bound Paclitaxel (Drug); 5-FU (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Sun Yat-sen University

Official(s) and/or principal investigator(s):
Ruihua Xu, PhD,MD, Principal Investigator, Affiliation: Sun Yat-sen University

Overall contact:
Ruihua Xu, PhD,MD, Phone: 862087343228, Email: xurh@sysucc.org.cn


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.

Clinical Details

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

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: PFS(Progression-free survival )

Secondary outcome: OS (Overall survival )


Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.


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


- 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


- 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


- Patients with known active infection with HIV.

- Known hypersensitivity to any of the study drugs

Locations and Contacts

Ruihua Xu, PhD,MD, Phone: 862087343228, Email: xurh@sysucc.org.cn

Sun Yat-sen University Cancer Center, Guangzhou, Guangdong 510060, China; Recruiting
Ruihua Xu, Ph D,MD, Phone: 862087343228
Dongsheng Zhang, Ph D,MD, Phone: 862087343795, Email: zhangdsh@sysucc.org.cn
Additional Information

Starting date: November 2010
Last updated: August 27, 2014

Page last updated: August 20, 2015

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