Endostar Combined With mFOLFOX6 for First-line Treatment of Metastatic Colorectal Cancer

Metastatic Colorectal Cancer Clinical Trial

Official title:

Study of Endostar Combined With mFOLFOX6 for First-line Treatment of Metastatic Colorectal Cancer and Efficacy Prediction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01832948
• Other study ID #: 20121201E-mCRC
• Status: Recruiting
• Phase: Phase 2
• First received: March 31, 2013
• Last updated: April 11, 2013
• Start date: January 2013
• Est. completion date: January 2015

Study information

• Verified date: April 2013
• Source: Zhejiang Cancer Hospital
• Contact: Liming Zhu, MD
• Phone: 0571-88122222
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Drug:
• Endostar

• Oxaliplatin

• Folinic acid

• 5-FU

Locations

Country	Name	City	State
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate (ORR)		the end of the 3rd cycle	No
Secondary	Blood perfusion in tumor tissue		baseline, the end of the 3rd cycle	No
Secondary	Ratio of blood perfusion in tumor tissue to blood perfusion in surrounding normal tissue		baseline, the end of the 3rd cycle	No
Secondary	Incidence of Adverse Events		up to 1 month after the last cycle	Yes