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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01980810
Recruitment Status : Terminated (recruit too slowly)
First Posted : November 11, 2013
Last Update Posted : June 14, 2016
Sponsor:
Information provided by (Responsible Party):
Lin Yang, Chinese Academy of Medical Sciences

Study Description
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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
Gastric Cancer Drug: albumin-bounded paclitaxel Drug: S-1 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
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Study Type : Interventional  (Clinical Trial)
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 : September 2013
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

Arms and Interventions
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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 Name: TS-1


Outcome Measures
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Primary Outcome Measures :
  1. response rate [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. progression free survival [ Time Frame: 1 year ]
  2. overall survival [ Time Frame: 1 year ]
  3. number of adverse event [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01980810


Locations
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China
Department of Medical Oncology,Cancer Hostpital and Institute,CAMS
Beijing, China, 100021
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Investigators
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Principal Investigator: Lin Yang, MD Department of medical oncology,Cancer hospital and institute,CAMS
More Information
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Responsible Party: Lin Yang, professor, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT01980810    
Other Study ID Numbers: CH-GI-037-nab
First Posted: November 11, 2013    Key Record Dates
Last Update Posted: June 14, 2016
Last Verified: June 2016
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
 Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action