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Trial record 47 of 297 for:    colon cancer AND Capecitabine AND chemotherapy

Recombinant Human Endostatin in Combination With XELOX Therapy in Patient With Advanced Colorectal Cancer. (EXECC)

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ClinicalTrials.gov Identifier: NCT03577392
Recruitment Status : Recruiting
First Posted : July 4, 2018
Last Update Posted : April 4, 2019
Sponsor:
Collaborator:
Jiangsu Simcere Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
ming zeng, MD, Sichuan Provincial People's Hospital

Brief Summary:
To study safety and efficacy of intravenous pump of recombinant human endostatin combined with XELOX-treated and also investigate the potential value of CECs level for the prediction of PD and outcomes in patients with advanced colorectal cancer.

Condition or disease Intervention/treatment Phase
Quality of Life Drug: oxaliplatin + capecitabine (XELOX chemotherapy) Drug: rebombniant human endostatin Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients were randomly assigned to receive either three treatment cycles of intravenous pump of recombinant human endostatin before chemotherapy.
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Intravenous Pump of Recombinant Human Endostatin Combined With XELOX Chemotherapy, and a Potential Prognostic Biomarkers in Patient With Advanced Colorectal Cancer
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : August 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: XELOX chemotherapy with recombinant human endotatin
Patients received a triweekly treatment cycle.Oxaliplatin(130mg/m2 over 2h)was intravenously administated for at least 2h on day 1. Capecitabine(1000mg/m2 twice daily)was oral administrated from the evening of day 1 to the morning of day 15.The dose of Recombinant human endostatin on day -5 was calculated according to the patients's body surface area, to provide a CIV 7 days' dose in physiological saline to 240mL volume.
Drug: oxaliplatin + capecitabine (XELOX chemotherapy)
Oxaliplatin(130mg/m2 over 2h)was intravenously administated for at least 2h on day 1. Capecitabine(1000mg/m2 twice daily)was oral administrated from the evening of day 1 to the morning of day 15.

Drug: rebombniant human endostatin
Endostar is a recombinat human endostatin with antiangiogenic properties that has been useful in treating a wide range of cancers and shows promise for use in combination treatment for advanced colorectal cancer. The dose of Recombinant human endostatin on day -5 was calculated according to the patients's body surface area, to provide a CIV 7 days' dose in physiological saline to 240mL volume.

Active Comparator: XELOX chemotherapy without recombinant human endotatin
Patients received a triweekly treatment cycle.Oxaliplatin(130mg/m2 over 2h)was intravenously administated for at least 2h on day 1. Capecitabine(1000mg/m2 twice daily)was oral administrated from the evening of day 1 to the morning of day 15.
Drug: oxaliplatin + capecitabine (XELOX chemotherapy)
Oxaliplatin(130mg/m2 over 2h)was intravenously administated for at least 2h on day 1. Capecitabine(1000mg/m2 twice daily)was oral administrated from the evening of day 1 to the morning of day 15.




Primary Outcome Measures :
  1. Progression free survival [ Time Frame: 4 years ]
    Evaluate the effect of XELOX therapy with or without recombinant human endostatin on progression free survival


Secondary Outcome Measures :
  1. local control [ Time Frame: 4 years ]
    To describe local control and out-of-field disease progression

  2. Overall survival [ Time Frame: 4 years ]
    comparison to maintenance XELOX chemotherapy alone.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clear pathology diagnosis of stage for the Ⅳ period of advanced colorectal cancer.
  • There are at least 1 imaging examinations according to the standard of RECIST(the longest diameter is at least 10mm with spiral CT and 20mm with ordinary CT).
  • Male or female , age 18~75
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • The patients had to have a life expectancy of at least 3 months.
  • A white blood count (WBC) greater than 3000/mm3, platelets greater than 100 000/mm3, and normal coagulation values.
  • Aspartate aminotransferase (AST) and adenosine triphosphate (ALT) values were to be less than 2.5 times the upper limit of normal;a bilirubin level of less than 25 lmol/l;a creatinine value less than 130 lmol/l.
  • Informed consent was obtained from all patients.

Exclusion Criteria:

  • Patients having a brain tumor or brain metastases, a bleeding disorder, receiving anti-coagulant therapy.
  • a history of myocardial infarction or angina pectoris in the last 6 months or uncontrolled congestive heart failure, having an active infection or receiving radio- or chemotherapy within 4 weeks before study.
  • patients with uncontrolled serious medical or psychiatric illness or having any other condition that was likely to interfere with regular follow-up.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03577392


Contacts
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Contact: Ke Xie, MD PhD 008618981838382 840246753@qq.com

Locations
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China, Sichuan
Sichuan Provincial People Hospital Recruiting
Chengdu, Sichuan, China, 61007
Contact: ke xie, MD PhD         
Contact: Xiong jingyan         
Sponsors and Collaborators
Sichuan Provincial People's Hospital
Jiangsu Simcere Pharmaceutical Co., Ltd.
Investigators
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Study Chair: Ke Xie, MD PhD Sichuan Provincial People Hospital

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Responsible Party: ming zeng, MD, Director of Cancer Center, Sichuan Provincial People's Hospital
ClinicalTrials.gov Identifier: NCT03577392     History of Changes
Other Study ID Numbers: SIM-ED-1512
First Posted: July 4, 2018    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Capecitabine
Oxaliplatin
Endostatins
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors