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

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: Stage IV Gastric Cancer With Metastasis
• Intervention / Treatment: Drug: second line chemoregime for advanced gastric cancer

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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	Evaluation progression-free survival (PFS) and overall survival (OS) RECIST(Response Evaluation Criteria In Solid Tumors)1.1: Complete response (CR); Partial response (PR); Stable disease(SD) and progression disease(PD); CR + PR is efficient.	2 years

Collaborators and Investigators

• Sponsor: Anhui Medical University
• Investigators: Principal Investigator: Yueyin Pan, MD, The First affiliated Hospital of Anhui Medical University

Study record dates

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: gastric cancer; second line chemoregime
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antibiotics, Antineoplastic; Topoisomerase I Inhibitors; Epirubicin; Irinotecan
• Other Study ID Numbers: SIEG