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

Stage IV Gastric Cancer With Metastasis Clinical Trial

— SIEG  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01964027
• Other study ID #: SIEG
• Status: Not yet recruiting
• Phase: Phase 2
• First received: January 19, 2012
• Last updated: October 14, 2013
• Start date: October 2013
• Est. completion date: December 2014

Study information

• Verified date: October 2013
• Source: Anhui Medical University
• Contact: Yueyin Pan, MD
• Phone: 865512922987
• Email: yueyinpan[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Stage IV Gastric Cancer With Metastasis
• Stomach Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Department of Oncology,The First Affiliated Hospital of Anhui Medical University	Hefei	Anhui

Sponsors (1)

Lead Sponsor	Collaborator
Anhui Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes