Status:
UNKNOWN
Endostar Combined With mFOLFOX6 for First-line Treatment of Metastatic Colorectal Cancer
Lead Sponsor:
Zhejiang Cancer Hospital
Conditions:
Metastatic Colorectal Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This study is to assess the efficacy and safety of Endostar combined with mFOLFOX6 in untreated metastatic colorectal cancer patients, and to find the markers that may predict the efficacy.
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed metastatic colorectal cancer (adenocarcinoma)
- 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
- Diagnosis of colorectal neuroendocrine tumor, undifferentiated carcinoma, adenosquamous carcinoma, squamous cell carcinoma
- 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
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2015
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01832948
Start Date
January 1 2013
End Date
January 1 2015
Last Update
April 16 2013
Active Locations (1)
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1
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China