First Line Chemotherapy for Advanced Cancer (GC-A-003)

June 11, 2016 updated by: Lin Yang, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Pase 2 Study of Albumin-bounded Paclitaxel Plus S-1 as First-line Chemotherapy for Locally Advanced or Metastatic Gastric or Gastro-esophageal Adenocarcinoma

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100021
        • Department of Medical Oncology,Cancer Hostpital and Institute,CAMS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: albumin-bounded paclitaxel plus 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
Drug: albumin-bounded paclitaxel
200mg iv d1, repeat every 2 weeks,until disease progression,or up to 9 cycles
Other Names:
  • Abraxane
  • Paclitaxel Albumin-stabilized Nanoparticle Formulation
Drug: S-1
40mg/m2 po, bid,d1-10,repeated every 2 weeks until disease progression
Other Names:
  • TS-1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
response rate
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: 1 year
1 year
progression free survival
Time Frame: 1 year
1 year
number of adverse event
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Investigators

  • Principal Investigator: Lin Yang, MD, Department of Medical Oncology,Cancer hospital and Institute,CAMS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

November 5, 2013

First Submitted That Met QC Criteria

November 5, 2013

First Posted (Estimate)

November 11, 2013

Study Record Updates

Last Update Posted (Estimate)

June 14, 2016

Last Update Submitted That Met QC Criteria

June 11, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CH-GI-037-nab

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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