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

NCT01238094 | Unknown Phase 3

• 1 other identifier: 2009-11-017
• Study Type: interventional
• Target: 258
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Colorectal Cancer

Keywords

colorectal cancer; simvastatin; second-line chemotherapy

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  12 months

Study Arms (1)

FOLFIRI or XELIRI/simvastatin

EXPERIMENTAL

FOLFIRI or XELIRI/simvastatin

Drug: Simvastatin

Interventions

Simvastatin DRUG

simvastatin 40 mg qd daily until disease progression

FOLFIRI or XELIRI/simvastatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Tumor type other than adenocarcinoma
• 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)
• Adjuvant or neo-adjuvant treatment for non-metastatic (M0) disease is allowed if completed at least 6 months prior to initiation of study treatment.
• 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.

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Won Ki Kang, MD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2010
• First Posted: November 10, 2010
• Study Start: April 1, 2010
• Primary Completion: November 1, 2013
• Study Completion: May 1, 2014
• Last Updated: June 14, 2013

Record last verified: 2012-01

Locations

KR (1)