NCT01529164

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
51

participants targeted

Target at P25-P50 for phase_2 colorectal-cancer

Timeline
Completed

Started Oct 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 8, 2012

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

November 27, 2013

Status Verified

November 1, 2013

Enrollment Period

2.9 years

First QC Date

February 4, 2012

Last Update Submit

November 26, 2013

Conditions

Colorectal Cancer

Keywords

endostatinchemotherapyantiangiogenesis agentcolorectal cancer

Outcome Measures

Primary Outcomes (1)

  • response rate

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

    3 years

Secondary Outcomes (3)

  • progression free survival

    3 years

  • overall survival

    3 years

  • Number of participants with adverse events

    3 years

Study Arms (1)

treatment

EXPERIMENTAL
Drug: Endostatins (Endostar)Drug: OxaliplatinDrug: LeucovorinDrug: 5-fluorouracil

Interventions

Endostatins (Endostar)DRUG

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

Also known as: Endostar
treatment
OxaliplatinDRUG

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

Also known as: Eloxatin
treatment
LeucovorinDRUG

200mg/m2 iv d1 ,repeat every 14 days

treatment
5-fluorouracilDRUG

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

treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer hospital & Institute,Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Endostatinsendostar proteinOxaliplatinLeucovorinFluorouracil

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Angiostatic ProteinsAngiogenic ProteinsIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsCollagen Type XVIIINon-Fibrillar CollagensCollagenExtracellular Matrix ProteinsScleroproteinsBiological FactorsCoordination ComplexesOrganic ChemicalsFormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsCoenzymesEnzymes and CoenzymesUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Lin Yang, MD

    Cancer hospital&institute,Chinese Academy of Medical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wen Zhang, MD

CONTACT

86-10-87788145wenwen0605@163.com

Lin Yang, MD

CONTACT

86-10-87788118lyang69@sina.com.cn

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associated professor

Study Record Dates

First Submitted

February 4, 2012

First Posted

February 8, 2012

Study Start

October 1, 2011

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

November 27, 2013

Record last verified: 2013-11

Locations

CN(1)