Endostar Combined With mFOLFOX6 for First-line Treatment of Metastatic Colorectal Cancer
Phase 2
- Conditions
- Metastatic Colorectal Cancer
- Interventions
- Registration Number
- NCT01832948
- Lead Sponsor
- Zhejiang Cancer Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment 5-FU 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 Treatment Folinic acid 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 Treatment Endostar 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 Treatment Oxaliplatin 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
- Primary Outcome Measures
Name Time Method Objective Response Rate (ORR) the end of the 3rd cycle
- Secondary Outcome Measures
Name Time Method Blood perfusion in tumor tissue baseline, the end of the 3rd cycle Ratio of blood perfusion in tumor tissue to blood perfusion in surrounding normal tissue baseline, the end of the 3rd cycle Incidence of Adverse Events up to 1 month after the last cycle
Trial Locations
- Locations (1)
Zhejiang Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China