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.

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: Simvastatin

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 Type: Interventional
• Enrollment (Anticipated): 258
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Samsung Medical Center
    • Contact: Hyejin Jang, RN; Phone Number: 822-3410-6859; Email: hyejin1217.jang@samsung.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: FOLFIRI or XELIRI/simvastatin	Drug: Simvastatin; simvastatin 40 mg qd daily until disease progression

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression free survival	12 months

Collaborators and Investigators

• Sponsor: Samsung Medical Center

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (ANTICIPATED): November 1, 2013
• Study Completion (ANTICIPATED): May 1, 2014

Study Registration Dates

• First Submitted: June 22, 2010
• First Submitted That Met QC Criteria: November 9, 2010
• First Posted (ESTIMATE): November 10, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): June 14, 2013
• Last Update Submitted That Met QC Criteria: June 13, 2013
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: colorectal cancer; simvastatin; second-line chemotherapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Simvastatin
• Other Study ID Numbers: 2009-11-017