First Line Chemotherapy for Advanced Cancer

Phase 2

Terminated

• Conditions: Gastric Cancer
• Interventions: Drug: albumin-bounded paclitaxel; Drug: S-1

• Registration Number: NCT01980810
• Lead Sponsor: Chinese Academy of Medical Sciences

Brief Summary

The purpose of this study is to determine whether albumine-bounded paclitaxel plus S-1 are effective in the treatment of advanced gastric or gastroesophageal junction adenocarcinoma.

Detailed Description

This phase II study was designed to evaluate the efficacy and safety of albumin-bounded paclitaxel combined with S-1 as first-line chemotherapy for inoperable and /or metastatic gastric or gastroesophageal junction cancer.Primary endpoint was overall response rate.

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-11-05
• Study First Submitted QC: 2013-11-05
• Study First Posted: 2013-11-11
• Primary Completion: 2015-02
• Study Completion: 2016-02
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-11
• Last Update Posted: 2016-06-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Inoperable locally advanced, recurrent, and/or metastatic adenocarcinoma of the stomach or gastro-esophageal junction
• Adult patients >=18 years of age
• Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-2;
• At least have one measurable disease(according to RECIST)
• Adequate bone marrow,renal and liver function

Exclusion Criteria

• Previous chemotherapy for advanced/metastatic disease
• Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
albumin-bounded paclitaxel plus S-1	albumin-bounded paclitaxel	arm 1:albumin-bounded paclitaxel 200mg iv d1 and S-1 80mg/m2/d po d1-10, repeated every 2 weeks,up to 9 cycles,then S-1 as single agent to treat to disease progression
albumin-bounded paclitaxel plus S-1	S-1	arm 1:albumin-bounded paclitaxel 200mg iv d1 and S-1 80mg/m2/d po d1-10, repeated every 2 weeks,up to 9 cycles,then S-1 as single agent to treat to disease progression

Primary Outcome Measures

Name	Time	Method
response rate	12 weeks

Secondary Outcome Measures

Name	Time	Method
overall survival	1 year
number of adverse event	1 year
progression free survival	1 year

Trial Locations

Locations (1)

Department of Medical Oncology,Cancer Hostpital and Institute,CAMS; 🇨🇳 Beijing, China