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

Phase 2

• Conditions: Gastric Caner
• Interventions: Drug: Albumin Bound Paclitaxel; Drug: 5-FU

• Registration Number: NCT02229045
• Lead Sponsor: Sun Yat-sen University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2014-03-08
• Status Verified: 2014-08
• Study First Submitted QC: 2014-08-27
• Last Update Submitted: 2014-08-27
• Study First Posted: 2014-08-29
• Last Update Posted: 2014-08-29
• Primary Completion: 2014-12
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 37

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.

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Albumin Bound Paclitaxel With 5-FU/CF	Albumin Bound Paclitaxel	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 With 5-FU/CF	5-FU	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.

Primary Outcome Measures

Name	Time	Method
PFS(Progression-free survival )	80% PFS events,, an expected average of 10 months	The PFS was calculated from the initiation of chemotherapy to the date of disease progression or death

Secondary Outcome Measures

Name	Time	Method
OS (Overall survival )	OS follow-up period: 18 months or 80% OS events, whichever occurs first	Overall survival was measured from the initiation of chemotherapy to the date of the last follow-up or death.

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China