Endostar Combined With mFOLFOX6 for First-line Treatment of Metastatic Colorectal Cancer
NCT ID: NCT01832948
Last Updated: 2013-04-16
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
30 participants
INTERVENTIONAL
2013-01-31
2015-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment
Endostar d1-d7 15mg/d Oxaliplatin 85 mg/m2 d6 Folinic acid 400 mg/m2 d6 5-FU 400 mg/m2 d6, and then 5-FU 2,400 mg/m2 INTRAVENOUS over 46 h
Endostar
Oxaliplatin
Folinic acid
5-FU
Interventions
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Endostar
Oxaliplatin
Folinic acid
5-FU
Eligibility Criteria
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Inclusion Criteria
* At least one measurable lesion (RECIST criteria)
* Life expectancy ≥ 3 months
* ECOG performance status 0-2
* Adequate hematologic function: ANC ≥ 1.5×109 /L，Hb ≥ 90 g/L，PLT ≥ 100×109 /L
* Adequate renal function: Cr ≤ 1.25×ULN or Creatinine clearance ≥ 60 ml/min
* Adequate hepatic function: BIL ≤ 1.5×ULN, ALT/AST ≤ 2.5×ULN, Alkaline phosphatase ≤ 5×ULN
* Patients have not previously received palliative chemotherapy, immunological/ biological treatment
* No adjuvant chemotherapy in last six months
* Target lesion has not received local radiotherapy
* Written informed consent
Exclusion Criteria
* Evidence of serious or uncontrolled infection
* Serious cardiovascular disease (congestive heart failure, uncontrollable arrhythmia, unstable angina, myocardial infarction, serious heart valve disease, resistant hypertension)
* Pregnant or lactating women
* Women of childbearing potential refused to practice acceptable methods of birth control to prevent pregnancy
* Allergic to any of the study drug
* Intestinal obstruction, intestinal perforation, or stroke within 3 months
* Participation in other clinical studies
18 Years
75 Years
ALL
No
Sponsors
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Zhejiang Cancer Hospital
OTHER
Responsible Party
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Principal Investigators
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Liming Zhu, MD
Role: PRINCIPAL_INVESTIGATOR
Zhejiang Cancer Hospital
Locations
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Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Liming Zhu, MD
Role: CONTACT
Facility Contacts
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Liming Zhu, MD
Role: primary
Other Identifiers
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20121201E-mCRC
Identifier Type: -
Identifier Source: org_study_id
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