Know Cancer

or
forgot password

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


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Metastatic Colorectal Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Objective Response Rate (ORR)

Outcome Time Frame:

the end of the 3rd cycle

Safety Issue:

No

Principal Investigator

Liming Zhu, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Zhejiang Cancer Hospital

Authority:

China: Food and Drug Administration

Study ID:

20121201E-mCRC

NCT ID:

NCT01832948

Start Date:

January 2013

Completion Date:

January 2015

Related Keywords:

  • Metastatic Colorectal Cancer
  • Colorectal Neoplasms

Name

Location