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

This study is currently recruiting participants.
Verified January 2012 by Samsung Medical Center
Sponsor:
Information provided by (Responsible Party):
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01238094
First received: June 22, 2010
Last updated: June 13, 2013
Last verified: January 2012
History of Changes

June 22, 2010
June 13, 2013
April 2010
November 2013   (final data collection date for primary outcome measure)
Progression free survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01238094 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Trial of XELIRI/FOLFIRI + Simvastatin Followed by Simvastatin Maintenance in Metastatic Colorectal Cancer
Placebo-controlled, Double-blinded Phase III Trial of XELIRI/FOLFIRI + Simvastatin Followed by Simvastatin Maintenance in Metastatic Colorectal Cancer

The purpose of this study is to compare 2nd line XELIRI/FOLFIRI + simvastatin vs XELIRI/FOLFIRI + placebo.

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Colorectal Cancer
Drug: Simvastatin
simvastatin 40 mg qd daily until disease progression
Other Name: simvastatin
Experimental: FOLFIRI or XELIRI/simvastatin
FOLFIRI or XELIRI/simvastatin
Intervention: Drug: Simvastatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
258
May 2014
November 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Not Provided
Korea, Republic of
 
NCT01238094
2009-11-017
No
Samsung Medical Center
Samsung Medical Center
Not Provided
Principal Investigator: Won Ki Kang, MD Samsung Medical Center
Samsung Medical Center
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP