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

Samsung Medical Center

Status and phase

Unknown

Phase 3

Conditions

Colorectal Cancer

Treatments

Drug: Simvastatin

Study type

Interventional

Funder types

Other

Identifiers

NCT01238094

2009-11-017

Details and patient eligibility

About

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

Full 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.

Enrollment

258 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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.