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Trial of XELIRI/FOLFIRI + Simvastatin Followed by Simvastatin Maintenance in Metastatic Colorectal Cancer

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: NCT01238094
Recruitment Status : Unknown
Verified January 2012 by Samsung Medical Center.
Recruitment status was:  Recruiting
First Posted : November 10, 2010
Last Update Posted : June 14, 2013
Sponsor:
Information provided by (Responsible Party):
Samsung Medical Center

Study Description
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Brief Summary:
The purpose of this study is to compare 2nd line XELIRI/FOLFIRI + simvastatin vs XELIRI/FOLFIRI + placebo.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: Simvastatin Phase 3

Detailed Description:
To compare progression free survival of the standard second line chemotherapy (FOLFIRI, XELIRI) plus simvastatin in metastatic colorectal cancer patients. This trial is a placebo-controlled study.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 258 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Placebo-controlled, Double-blinded Phase III Trial of XELIRI/FOLFIRI + Simvastatin Followed by Simvastatin Maintenance in Metastatic Colorectal Cancer
Study Start Date : April 2010
Estimated Primary Completion Date : November 2013
Estimated Study Completion Date : May 2014

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: FOLFIRI or XELIRI/simvastatin
FOLFIRI or XELIRI/simvastatin
 Drug: Simvastatin
simvastatin 40 mg qd daily until disease progression


Outcome Measures
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Primary Outcome Measures :
  1. Progression free survival [ Time Frame: 12 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Histologically documented colorectal adenocarcinoma (previously failed to oxaliplatin)
  2. Age over 19 years old
  3. Performance status (ECOG scale): 0-2
  4. Measurable or evaluable disease
  5. Adequate organ functions
  6. Life expectancy ≥ 3 months
  7. No history of statin treatment within the last 12 months
  8. Patients should sign a written informed consent before study entry.

Exclusion Criteria:

  1. Tumor type other than adenocarcinoma
  2. Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin, papillary thyroid carcinoma or prior malignancy treated more than 5 years ago without recurrence)
  3. Adjuvant or neo-adjuvant treatment for non-metastatic (M0) disease is allowed if completed at least 6 months prior to initiation of study treatment.
  4. Prior radiotherapy is permitted if it was not administered to target lesions selected for this study, unless progression of the selected target lesions within the radiation portal is documented, and provided it has been completed at least 4 weeks before randomization.
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): NCT01238094


Locations
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Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Hyejin Jang, RN    822-3410-6859    hyejin1217.jang@samsung.com   
Sponsors and Collaborators
Samsung Medical Center
Investigators
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Principal Investigator: Won Ki Kang, MD Samsung Medical Center
More Information
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Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01238094    
Other Study ID Numbers: 2009-11-017
First Posted: November 10, 2010    Key Record Dates
Last Update Posted: June 14, 2013
Last Verified: January 2012
Keywords provided by Samsung Medical Center:
colorectal cancer
simvastatin
second-line chemotherapy
Additional relevant MeSH terms:
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Simvastatin
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
 Intestinal Diseases
Rectal Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors