First Line Chemotherapy for Advanced Cancer

Phase 2TerminatedNCT01980810

Chinese Academy of Medical Sciences36 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Gastric Cancer

Interventions

albumin-bounded paclitaxelDRUG

200mg iv d1, repeat every 2 weeks,until disease progression,or up to 9 cycles

S-1DRUG

40mg/m2 po, bid,d1-10,repeated every 2 weeks until disease progression

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Medical Oncology,Cancer Hostpital and Institute,CAMS

Beijing, China

Outcomes

Primary Outcomes

response rate

Time frame: 12 weeks

Secondary Outcomes

progression free survival

Time frame: 1 year

overall survival

Time frame: 1 year

number of adverse event

Time frame: 1 year

Data from ClinicalTrials.gov

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