The Study of Irinotecan Plus Epirubicin as the Second-line Chemoregime for Advanced Gastric Cancer
Conditions
Stage IV Gastric Cancer With Metastasis
Conditions: official terms
Stomach Neoplasms
Conditions: Keywords
second line chemoregime, gastric cancer
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: second line chemoregime for advanced gastric cancer
Type: Drug
Overall Status
Not yet recruiting
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.
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)
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Location
Department of Oncology,The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Status: Not yet recruiting
Contact: Yueyin Pan, MD - 865512922987 - yueyinpan@gmail.com
Start Date
October 2013
Completion Date
December 2014
Sponsors
Anhui Medical University
Source
Anhui Medical University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page