The Study of Irinotecan Plus Epirubicin as the Second-line Chemoregime for Advanced Gastric Cancer
NCT ID: NCT01964027
Last Updated: 2013-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
40 participants
INTERVENTIONAL
2013-10-31
2014-12-31
Brief Summary
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Detailed Description
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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)
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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
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
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Anhui Medical University
OTHER
Responsible Party
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Pan Yueyin
Professor
Principal Investigators
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Yueyin Pan, MD
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Anhui Medical University
Locations
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Department of Oncology,The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Countries
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Central Contacts
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Facility Contacts
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Yueyin Pan, MD
Role: primary
Other Identifiers
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SIEG
Identifier Type: -
Identifier Source: org_study_id