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

University of Chinese Academy Sciences

Status and phase

Unknown

Phase 2

Conditions

Metastatic Colorectal Cancer

Treatments

Drug: Endostar

Drug: Oxaliplatin

Drug: 5-FU

Drug: Folinic acid

Study type

Interventional

Funder types

Other

Identifiers

NCT01832948

20121201E-mCRC

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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