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A Single Arm, Phase II Study of Simvastatin Plus XELOX and Bevacizumab as First-line Chemotherapy in Metastatic Colorectal Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02026583
Recruitment Status : Completed
First Posted : January 3, 2014
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):
Won Ki Kang, Samsung Medical Center

Study Description
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Brief Summary:

  1. Study Objectives 1) Primary Objective: Progression-free survival 2) Secondary Objectives:

    1. overall survival
    2. response rate
    3. incidence, nature and severity of all adverse events
    4. lipid lowering effect of simvastatin
    5. exploratory biomarker analysis : angiopoietin 2, BiP (Binding protein), Hsp (Heat shck protein) 90α
  2. Study hypothesis In our recent in vitro study, addition of simvastatin to bevacizumab reduced proliferation, migration, invasion and tumor formation of endothelial cell. Moreover, colorectal cancer cell media which was treated with simvastatin combined with bevacizumab inhibited endothelial cell invasion and it was associated with decreased mediator of angiogenesis, such as angiopoietin 2, BiP and HSP 90α.. Treatment with bevacizumab and simvastatin more reduced the growth of xenograft tumors compared with bevacizumab alone.
  3. Assessments 1) Safety : physical examination, vital signs, body weight, ECOG (Eastern Cooperative Oncology Group) performance status, clinical laboratory evaluation (chemistry, blood cell count) and any AE (adverse effect) graded by using CTCAE (Common Toxicity Criteria for Adverse Effects ) v 4.0 2) Efficacy : progression-free survival and overall survival will be collected. Response rate according to RECIST (Response Evaluation Criteria in Solid Tumors) 1,1 guideline will also be evaluated 3) PFS (Progression free survival): time from randomization to tumor progression or death 4) OS (Overall survival) : time from randomization to death or last follow-up 5) Biomarker analysis; The correlation between blood level, protein expression of angiopoietin 2, BiP, Hsp90α and clinical response will be explored.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: Simvastatin Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Arm, Phase II Study of Simvastatin Plus XELOX and Bevacizumab as First-line Chemotherapy in Metastatic Colorectal Cancer Patients
Actual Study Start Date : December 2013
Actual Primary Completion Date : April 28, 2017
Actual Study Completion Date : April 28, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Simvastatin

Arms and Interventions
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Arm Intervention/treatment
Experimental: Simvastatin Drug: Simvastatin


Outcome Measures
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Primary Outcome Measures :
  1. Progression free survival [ Time Frame: During treatment : up to 6weeks, off the treatment : up to 8weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically-confirmed colorectal carcinoma
  2. Stage IV or recurrent colorectal cancer
  3. age ≥ 20 years
  4. ECOG performance status ≤1
  5. At least one measurable tumor mass according to RECIST 1.1
  6. Expected survival for approximately 12 weeks or longer
  7. No prior systemic chemotherapy
  8. At least 4 weeks later after surgery or radiotherapy
  9. At least 12 months after adjuvant chemotherapy

Exclusion Criteria:

  1. Prior statins therapy within 1-year from the date of study entry
  2. Prior chemotherapeutic treatment for metastatic colorectal cancer.
  3. Prior other anti-VEGF (vascular endothelial growth factor) or TKIs (Tyrosine kinase inhibitors) treatment
  4. Current, Known CNS(central nervous system) malignancy (history of completely resected or irradiated brain metastases by WBRT (whole-brain radiation therapy) or stereotactic radiosurgery allowed.
  5. Severe or unstable cardiac disease, including (for example) coronary artery disease requiring increased doses of anti-anginal medication and/or coronary angioplasty (including stent placement) within the preceding 24 months(congestive heart failure NYHA (New York Heart Association) III or IV, unstable angina pectoris, history of myocardial infarction within the last twelve months, significant arrhythmias)
  6. Past or current history (within the last 5 years prior to treatment start) of other malignancies except metastatic colorectal cancer (Patients with curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible)
  7. Uncontrolled systemic illness such as DM (diabetes mellitus), hypertension, hypothyroidism and infection
  8. History of thromboembolic or hemorrhagic events within 6 months prior to treatment
  9. History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months prior to enrollment.
  10. Evidence of bleeding diathesis or coagulopathy
Contacts and Locations
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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): NCT02026583


Locations
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Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Samsung Medical Center
More Information
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Responsible Party: Won Ki Kang, Professor of Medicine, Sungkyunkwan University School of Medicine, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02026583    
Other Study ID Numbers: IRB no : 2013-07-088
First Posted: January 3, 2014    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
 Rectal Diseases
Simvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors