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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Samsung Medical Center.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
Samsung Medical Center Identifier:
First received: June 22, 2010
Last updated: June 13, 2013
Last verified: January 2012
The purpose of this study is to compare 2nd line XELIRI/FOLFIRI + simvastatin vs XELIRI/FOLFIRI + placebo.

Condition Intervention Phase
Colorectal Cancer
Drug: Simvastatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Progression free survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 258
Study Start Date: April 2010
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FOLFIRI or XELIRI/simvastatin
FOLFIRI or XELIRI/simvastatin
Drug: Simvastatin
simvastatin 40 mg qd daily until disease progression

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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT01238094

Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Hyejin Jang, RN    822-3410-6859   
Sponsors and Collaborators
Samsung Medical Center
Principal Investigator: Won Ki Kang, MD Samsung Medical Center
  More Information

Responsible Party: Samsung Medical Center Identifier: NCT01238094     History of Changes
Other Study ID Numbers: 2009-11-017 
Study First Received: June 22, 2010
Last Updated: June 13, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Samsung Medical Center:
colorectal cancer
second-line chemotherapy

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms by Site
Rectal Diseases
Anticholesteremic Agents
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action processed this record on May 26, 2016