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

Colorectal Cancer Clinical Trial

Official title:

Placebo-controlled, Double-blinded Phase III Trial of XELIRI/FOLFIRI + Simvastatin Followed by Simvastatin Maintenance in Metastatic Colorectal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01238094
• Other study ID #: 2009-11-017
• Status: Recruiting
• Phase: Phase 3
• First received: June 22, 2010
• Last updated: June 13, 2013
• Start date: April 2010
• Est. completion date: May 2014

Study information

• Verified date: January 2012
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 258
• Est. completion date: May 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• Simvastatin
simvastatin 40 mg qd daily until disease progression

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival		12 months	No