The Study of Irinotecan Plus Epirubicin as the Second-line Chemoregime for Advanced Gastric Cancer (SIEG)

October 14, 2013 updated by: Pan Yueyin, Anhui Medical University
This study is to determine the response rate and safety profile of irinotecan plus epirubicin as the second-line chemotherapy for advanced gastric cancer and fully evaluate the feasibility and effectiveness of the regime.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The main purposes: to determine the progression-free survival (PFS) and overall survival (OS) of gastric cancer patients given irinotecan + epirubicin as second-line treatment, who are at Stage IV with disease progressed or recurred after first-line chemotherapy failed, ,

The Secondary purposes: to determine disease control rate (Disease Control Rate, DCR), the objective response rate (Object Response rate, ORR) and the Quality of life (Quality Of Life, QOL)

Study Type

Interventional

Enrollment (Anticipated)

40

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
    • Anhui
      • Hefei, Anhui, China, 230032
        • Department of Oncology,The First Affiliated Hospital of Anhui Medical University

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 to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Aged between 18 to 70 years
  • The pathologically confirmed gastric adenocarcinoma and the failure of first-line chemotherapy
  • Measurable lesions outside the stomach
  • ECOG(Eastern Cooperative Oncology Group ) score between 0 to 1
  • Expected survival time of at least 3 months
  • Subjects receiving treatment for other damage caused has been restored, which it accepted the nitroso or mitomycin interval> 6 weeks, the acceptance of other cytotoxic drugs, radiotherapy or surgery> = 4 weeks, and the wound has completely healed. No bleeding, no nervous system transferred
  • Blood and organ function was normal

Exclusion criteria:

  • Comorbid with other malignant tumors
  • Pregnant and lactating women
  • with the disease of endangering patient's safety and affecting the completion of the study
  • Patients suffering from high blood pressure by antihypertensive treatment cannot control (systolic blood pressure> 140mmhg, diastolic blood pressure> 90mmhg,) there is more than Class I and Class I arrhythmia coronary heart disease, with more than Class I heart dysfunction
  • Major organ failure, such as decompensated heart and lung failure, liver failure, renal failure and patients with intestinal obstruction ipate in other clinical trials of patients in the past four weeks
  • Participated in clinical trials with other drugs or using other drugs during past 4 weeks
  • Lesions which can't be measured such as pleural effusion, ascites, peritoneal cancer lesions, diffuse liver and bone metastases violation, brain metastasis

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: Irinotecan plus epirubicin
Irinotecan(Camptosar)150mg /m2 d1,（intravenous infusion of 30-90 minutes) + epirubicin(Pharmorubicin) 50mg/m2 (total dose does not exceed 700mg/m2) every 21days for 1 treatment * 6 cycles as the second line chemoregime for advanced gastric cancer
Drug: second line chemoregime for advanced gastric cancer
Irinotecan(Camptosar)150mg /m2 d1,（intravenous infusion of 30-90 minutes) + epirubicin(Pharmorubicin) 50mg/m2 (total dose does not exceed 700mg/m2) every 21days for 1 treatment * 6 cycles as the second line chemoregime for advanced gastric cancer
Other Names:
  • irinotecan plus epirubicin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS and OS
Time Frame: 2 years

Evaluation progression-free survival (PFS) and overall survival (OS)

RECIST(Response Evaluation Criteria In Solid Tumors)1.1:

  1. Complete response (CR)
  2. Partial response (PR)
  3. Stable disease(SD) and progression disease(PD)
  4. CR + PR is efficient.
2 years

Collaborators and Investigators

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

Sponsor

Anhui Medical University

Investigators

  • Principal Investigator: Yueyin Pan, MD, The First Affiliated Hospital of Anhui Medical University

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

October 1, 2013

Primary Completion (Anticipated)

July 1, 2014

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

January 19, 2012

First Submitted That Met QC Criteria

October 14, 2013

First Posted (Estimate)

October 17, 2013

Study Record Updates

Last Update Posted (Estimate)

October 17, 2013

Last Update Submitted That Met QC Criteria

October 14, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIEG

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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