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Efficacy and Safety Study of Recombinant Endostatin Combined With Chemotherapy to Treat Advanced Colorectal Cancer

NCT01529164 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2013-11-27

No results posted yet for this study

Summary

Studies suggest that the addition of antiangiogenic agents to conventional therapeutic strategies, e.g., chemotherapy, radiation, or other tumor-targeting agents, will increase clinical efficacy. For advanced colorectal cancer,the antiangiogenic agent bevacizumab has become an important treatment option and its combination with chemotherapy is now being one of the standard first line therapy. This phase II study was conducted to determine the efficacy and safety of another antiangiogenesis inhibitor rh-endostatin plus mFOLFOX6 in advanced colorectal cancer.

Conditions

Interventions

DRUG

Endostatins (Endostar)

7.5mg/m2 iv d1-10,repeat every 14 days,until progression or occurrence of untolerated toxicity

DRUG

Oxaliplatin

85mg/m2 iv d1 ,repeat every 14 days,until progression or occurrence of untolerated toxicity

DRUG

Leucovorin

200mg/m2 iv d1 ,repeat every 14 days

DRUG

5-fluorouracil

400mg/m2 iv bolus,then 2400mg/m2 continuous infusion for 46 hours,repeated every 14 days,until progression or occurrence of untolerated toxicity

Sponsors & Collaborators

  • Simcere Pharmaceutical Co., Ltd

    collaborator OTHER

  • Chinese Academy of Medical Sciences

    lead OTHER

Principal Investigators

  • Lin Yang, MD · Cancer hospital&institute,Chinese Academy of Medical Sciences

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01529164 on ClinicalTrials.gov