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