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GC-A-003: First Line Chemotherapy for Advanced Cancer

Sponsor
Chinese Academy of Medical Sciences (Other)
Overall Status
Terminated
CT.gov ID
NCT01980810
Collaborator
(none)
36
Enrollment
1
Location
1
Arm
29
Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
36 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Pase 2 Study of Albumin-bounded Paclitaxel Plus S-1 as First-line Chemotherapy for Locally Advanced or Metastatic Gastric or Gastro-esophageal Adenocarcinoma
Study Start Date :
Sep 1, 2013
Actual Primary Completion Date :
Feb 1, 2015
Actual Study Completion Date :
Feb 1, 2016

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. response rate [12 weeks]

    Secondary Outcome Measures

    1. progression free survival [1 year]

    2. overall survival [1 year]

    3. number of adverse event [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Medical Oncology,Cancer Hostpital and Institute,CAMS Beijing China 100021

    Sponsors and Collaborators

    • Chinese Academy of Medical Sciences

    Investigators

    • Principal Investigator: Lin Yang, MD, Department of medical oncology,Cancer hospital and institute,CAMS

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Lin Yang, professor, Chinese Academy of Medical Sciences
    ClinicalTrials.gov Identifier:
    NCT01980810
    Other Study ID Numbers:
    • CH-GI-037-nab
    First Posted:
    Nov 11, 2013
    Last Update Posted:
    Jun 14, 2016
    Last Verified:
    Jun 1, 2016
    Additional relevant MeSH terms:
    Stomach Neoplasms
    Paclitaxel
    Albumin-Bound Paclitaxel

    Study Results

    No Results Posted as of Jun 14, 2016