Efficacy and Safety Study of Recombinant Endostatin Combined With Chemotherapy to Treat Advanced Colorectal Cancer
NCT ID: NCT01529164
Last Updated: 2013-11-27
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
51 participants
INTERVENTIONAL
2011-10-31
2014-09-30
Brief Summary
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Detailed Description
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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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treatment
Endostatins (Endostar)
7.5mg/m2 iv d1-10,repeat every 14 days,until progression or occurrence of untolerated toxicity
Oxaliplatin
85mg/m2 iv d1 ,repeat every 14 days,until progression or occurrence of untolerated toxicity
Leucovorin
200mg/m2 iv d1 ,repeat every 14 days
5-fluorouracil
400mg/m2 iv bolus,then 2400mg/m2 continuous infusion for 46 hours,repeated every 14 days,until progression or occurrence of untolerated toxicity
Interventions
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Endostatins (Endostar)
7.5mg/m2 iv d1-10,repeat every 14 days,until progression or occurrence of untolerated toxicity
Oxaliplatin
85mg/m2 iv d1 ,repeat every 14 days,until progression or occurrence of untolerated toxicity
Leucovorin
200mg/m2 iv d1 ,repeat every 14 days
5-fluorouracil
400mg/m2 iv bolus,then 2400mg/m2 continuous infusion for 46 hours,repeated every 14 days,until progression or occurrence of untolerated toxicity
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age greater than or equal to 18 years
* Histologically or cytologically confirmed metastatic or recurrent colorectal tumors with no previous treatment for advanced disease.
* At least one measurable lesion according to the RECIST criteria which has not been irradiated (i.e. newly arising lesions in previously irradiated areas are accepted). Minimum indicator lesion size: \> 10 mm measured by spiral CT or \>20mm measured by conventional techniques
* ECOG performance status 0-1
* Life expectancy \> 3 months
* ECG is normal
Exclusion Criteria
* Any prior oxaliplatin treatment, with the exception of adjuvant therapy given \> 12 months prior to the beginning of study therapy,and any prior 5-fluorouracil treatment, with the exception of adjuvant therapy given \> 6 months prior to the beginning of study therapy
* Any prior endostatin treatment
* known hypersensitivity to 5-fluorouracil,oxaliplatin,leucovorin
* History of persistent neurosensory disorder including but not limited to peripheral neuropathy
* known DPD deficiency
* Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cervical cancer
* Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) within the last 6 months
* Any of the following laboratory values:
* Abnormal hematologic values (neutrophils \< 1.5 x 109/L, platelet count \< 100 x 109/L)
* Urine protein: creatinine ratio \>/= 1.0, Impaired renal function with estimated creatinine clearance \< 30 ml/min
* Serum bilirubin \> 1.5 x upper normal limit. ALT, AST \> 2.5 x upper normal limit (or \> 5 x upper normal limit in the case of liver metastases)
* Alkaline phosphatase \> 2.5 x upper normal limit (or \> 5 x upper normal limit in the case of liver metastases or \> 10 x upper normal limit in the case of bone disease)
* use of full-dose anticoagulants or thrombolytics
* known CNS metastases
* serious nonhealing wound, ulcer, or bone fracture
* clinically significant bleeding diathesis or coagulopathy
18 Years
ALL
No
Sponsors
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Simcere Pharmaceutical Co., Ltd
OTHER
Chinese Academy of Medical Sciences
OTHER
Responsible Party
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Lin Yang
associated professor
Principal Investigators
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Lin Yang, MD
Role: PRINCIPAL_INVESTIGATOR
Cancer hospital&institute,Chinese Academy of Medical Sciences
Locations
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Cancer hospital & Institute,Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Wen Zhang, MD
Role: primary
Lin Yang, MD
Role: backup
Other Identifiers
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CH-GI-023
Identifier Type: -
Identifier Source: org_study_id