First Line Chemotherapy for Advanced Cancer

Gastric Cancer Clinical Trial

— GC-A-003  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01980810
• Other study ID #: CH-GI-037-nab
• Status: Terminated
• Phase: Phase 2
• First received: November 5, 2013
• Last updated: June 11, 2016
• Start date: September 2013
• Est. completion date: February 2016

Study information

• Verified date: June 2016
• Source: Chinese Academy of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 36
• Est. completion date: February 2016
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer

Intervention

Drug:
• albumin-bounded paclitaxel
200mg iv d1, repeat every 2 weeks,until disease progression,or up to 9 cycles
• S-1
40mg/m2 po, bid,d1-10,repeated every 2 weeks until disease progression

Locations

Country	Name	City	State
China	Department of Medical Oncology,Cancer Hostpital and Institute,CAMS	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	response rate		12 weeks	No
Secondary	progression free survival		1 year	No
Secondary	overall survival		1 year	No
Secondary	number of adverse event		1 year	Yes