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

Primary Purpose

Colorectal Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Endostatins (Endostar)
Oxaliplatin
Leucovorin
5-fluorouracil
Sponsored by
Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring endostatin, chemotherapy, antiangiogenesis agent, colorectal cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Signed informed consent (IC)
  • Age greater than or equal to 18 years
  • Histologically or cytologically confirmed metastatic or recurrent colorectal tumors with no previous treatment for advanced disease.
  • At least one measurable lesion according to the RECIST criteria which has not been irradiated (i.e. newly arising lesions in previously irradiated areas are accepted). Minimum indicator lesion size: > 10 mm measured by spiral CT or >20mm measured by conventional techniques
  • ECOG performance status 0-1
  • Life expectancy > 3 months
  • ECG is normal

Exclusion Criteria:

  • Pregnant or lactating woman
  • Any prior oxaliplatin treatment, with the exception of adjuvant therapy given > 12 months prior to the beginning of study therapy,and any prior 5-fluorouracil treatment, with the exception of adjuvant therapy given > 6 months prior to the beginning of study therapy
  • Any prior endostatin treatment
  • known hypersensitivity to 5-fluorouracil,oxaliplatin,leucovorin
  • History of persistent neurosensory disorder including but not limited to peripheral neuropathy
  • known DPD deficiency
  • Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cervical cancer
  • Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) within the last 6 months

  • Any of the following laboratory values:

    • Abnormal hematologic values (neutrophils < 1.5 x 109/L, platelet count < 100 x 109/L)
    • Urine protein: creatinine ratio >/= 1.0, Impaired renal function with estimated creatinine clearance < 30 ml/min
    • Serum bilirubin > 1.5 x upper normal limit. ALT, AST > 2.5 x upper normal limit (or > 5 x upper normal limit in the case of liver metastases)
    • Alkaline phosphatase > 2.5 x upper normal limit (or > 5 x upper normal limit in the case of liver metastases or > 10 x upper normal limit in the case of bone disease)
  • use of full-dose anticoagulants or thrombolytics
  • known CNS metastases
  • serious nonhealing wound, ulcer, or bone fracture
  • clinically significant bleeding diathesis or coagulopathy

Sites / Locations

  • Cancer hospital & Institute,Chinese Academy of Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

treatment

Arm Description

Outcomes

Primary Outcome Measures

response rate
From date of treatment was administered until the date of first documented response according to RECIST criteria

Secondary Outcome Measures

progression free survival
From date of chemotherapy was administered until the date of first documented progression or date of death from any cause, whichever came first, assessed every 8 weeks.
overall survival
From date of treatment was administered until the date of death from any cause, assessed every 3 months.
Number of participants with adverse events
assessed from the date of treatment to 1 month after stop treatment

Full Information

First Posted
February 4, 2012
Last Updated
November 26, 2013
Sponsor
Chinese Academy of Medical Sciences
Collaborators
Simcere Pharmaceutical Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT01529164
Brief Title
Efficacy and Safety Study of Recombinant Endostatin Combined With Chemotherapy to Treat Advanced Colorectal Cancer
Official Title
Phase II Study of Recombinant Endostatin Combined With Modified FOLFOX6 in Advanced Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Unknown status
Study Start Date
October 2011 (undefined)
Primary Completion Date
September 2014 (Anticipated)
Study Completion Date
September 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences
Collaborators
Simcere Pharmaceutical Co., Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
Rh-Endostatin (Endostar; Simcere Pharmaceutical Co., Ltd, JiangSu,China) is a humanized recombinant endostatin which is a direct angiogenesis inhibitor targeting the microvascular endothelial cells (ECs). A pivotal phase III study completed in China demonstrated that the addition of rh-endostatin to navelbine plus cisplatin conferred clinically significant improvements in overall survival (OS), progression-free survival (PFS), as well as response rate (RR), in patients with previously untreated metastatic non small cell lung cancer (NSCLC). In vitro, the combination of Endostatin and fluorouracil showed synergistic activity in inhibiting colon cancer. MFolfox6 was standard first-line regimen in advanced colorectal cancer. The investigators carried out a phase II trial to investigate the activity and safety of rh-endostatin plus mFOLFOX in patients with metastatic colorectal cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
endostatin, chemotherapy, antiangiogenesis agent, colorectal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
treatment
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Endostatins (Endostar)
Other Intervention Name(s)
Endostar
Intervention Description
7.5mg/m2 iv d1-10,repeat every 14 days,until progression or occurrence of untolerated toxicity
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Other Intervention Name(s)
Eloxatin
Intervention Description
85mg/m2 iv d1 ,repeat every 14 days,until progression or occurrence of untolerated toxicity
Intervention Type
Drug
Intervention Name(s)
Leucovorin
Intervention Description
200mg/m2 iv d1 ,repeat every 14 days
Intervention Type
Drug
Intervention Name(s)
5-fluorouracil
Intervention Description
400mg/m2 iv bolus,then 2400mg/m2 continuous infusion for 46 hours,repeated every 14 days,until progression or occurrence of untolerated toxicity
Primary Outcome Measure Information:
Title
response rate
Description
From date of treatment was administered until the date of first documented response according to RECIST criteria
Time Frame
3 years
Secondary Outcome Measure Information:
Title
progression free survival
Description
From date of chemotherapy was administered until the date of first documented progression or date of death from any cause, whichever came first, assessed every 8 weeks.
Time Frame
3 years
Title
overall survival
Description
From date of treatment was administered until the date of death from any cause, assessed every 3 months.
Time Frame
3 years
Title
Number of participants with adverse events
Description
assessed from the date of treatment to 1 month after stop treatment
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed informed consent (IC) Age greater than or equal to 18 years Histologically or cytologically confirmed metastatic or recurrent colorectal tumors with no previous treatment for advanced disease. At least one measurable lesion according to the RECIST criteria which has not been irradiated (i.e. newly arising lesions in previously irradiated areas are accepted). Minimum indicator lesion size: > 10 mm measured by spiral CT or >20mm measured by conventional techniques ECOG performance status 0-1 Life expectancy > 3 months ECG is normal Exclusion Criteria: Pregnant or lactating woman Any prior oxaliplatin treatment, with the exception of adjuvant therapy given > 12 months prior to the beginning of study therapy,and any prior 5-fluorouracil treatment, with the exception of adjuvant therapy given > 6 months prior to the beginning of study therapy Any prior endostatin treatment known hypersensitivity to 5-fluorouracil,oxaliplatin,leucovorin History of persistent neurosensory disorder including but not limited to peripheral neuropathy known DPD deficiency Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cervical cancer Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) within the last 6 months Any of the following laboratory values: Abnormal hematologic values (neutrophils < 1.5 x 109/L, platelet count < 100 x 109/L) Urine protein: creatinine ratio >/= 1.0, Impaired renal function with estimated creatinine clearance < 30 ml/min Serum bilirubin > 1.5 x upper normal limit. ALT, AST > 2.5 x upper normal limit (or > 5 x upper normal limit in the case of liver metastases) Alkaline phosphatase > 2.5 x upper normal limit (or > 5 x upper normal limit in the case of liver metastases or > 10 x upper normal limit in the case of bone disease) use of full-dose anticoagulants or thrombolytics known CNS metastases serious nonhealing wound, ulcer, or bone fracture clinically significant bleeding diathesis or coagulopathy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wen Zhang, MD
Phone
86-10-87788145
Email
wenwen0605@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lin Yang, MD
Phone
86-10-87788118
Email
lyang69@sina.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lin Yang, MD
Organizational Affiliation
Cancer hospital&institute,Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer hospital & Institute,Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wen Zhang, MD
Phone
86-10-87788145
Email
wenwen0605@163.com
First Name & Middle Initial & Last Name & Degree
Lin Yang, MD
Phone
86-10-87788118
Email
lyang69@sina.com.cn
First Name & Middle Initial & Last Name & Degree
Lin Yang, MD

12. IPD Sharing Statement

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

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