Clinical trial NCT01964027: The Study of Irinotecan Plus Epirubicin as the Second-line Chemoregime for Advanced Gastric Cancer
Official title: The Study of Irinotecan Plus Epirubicin as the Second-line Chemoregime for Advanced Gastric Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Stage IV Gastric Cancer With Metastasis
Keywords: second line chemoregime
gastric cancer
Lead sponsor: Anhui Medical University
Sponsor class: OTHER
First posted: 2013-10-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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)

Eligibility 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

Primary outcomes:
measure: PFS and OS
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Hefei
country: China
facility: Department of Oncology,The First Affiliated Hospital of Anhui Medical University
state: Anhui
Study officials:
affiliation: The First Affiliated Hospital of Anhui Medical University
name: Yueyin Pan, MD
role: PRINCIPAL_INVESTIGATOR
References: