Simvastatin + Cetuximab/Irinotecan in K-ras Mutant Colorectal Cancer (CRC)
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ClinicalTrials.gov Identifier: NCT01281761 |
Recruitment Status
:
Completed
First Posted
: January 24, 2011
Last Update Posted
: June 14, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Metastatic Colorectal Cancer | Drug: cetuximab/irinotecan/simvastatin | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 52 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase II Simvastatin + Cetuximab/Irinotecan in K-ras Mutant Colorectal Cancer Patients Who Have Failed Irinotecan and Oxaliplatin-based Chemotherapy |
Study Start Date : | November 2010 |
Actual Primary Completion Date : | September 2012 |
Actual Study Completion Date : | December 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: cetuximab/irinotecan/simvastatin
D1 Cetuximab 500mg/m2 IV stepwise shortened infusion duration- [C1D1 over 120min, C2D1 over 90min,subsequent dose over 60min] D1 Irinotecan 150-180mg/m2 + Dextrose 5% 500ml IV [over 90min] D1-14 Simvastatin 80mg P.O(continuous, daily)
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Drug: cetuximab/irinotecan/simvastatin
D1 Cetuximab 500mg/m2 IV stepwise shortened infusion duration- [C1D1 over 120min, C2D1 over 90min,subsequent dose over 60min] D1 Irinotecan 150-180mg/m2 + Dextrose 5% 500ml IV [over 90min] D1-14 Simvastatin 80mg P.O(continuous, daily) every 2weeks
|
- response rate [ Time Frame: 12 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically-confirmed, advanced/metastatic colorectal carcinoma Failed both oxaliplatin and irinotecan based regimens for advanced/metastatic disease (last regimen has to be irinotecan-based chemotherapy; To be eligible, patients must also have received one of several qualifying, irinotecan regimens for at least 6 weeks and must have had documented progression of disease during receipt of this regimen or within six months thereafter.
- Ras mutation (+) (checked at the central lab)
- At least one measurable tumor mass according to RECIST 1.1
- Expected survival for approximately 12 weeks or longer
- Karnofsky Performance Score (KPS) ≥ 70
- Age ≥ 18 years
- WBC ≥ 3,500 cells/mm3 and ≤ 50,000 cells/mm3
- ANC ≥ 1,500 cells/mm3
- Hemoglobin ≥ 10 g/dL (transfusion allowed)
- Platelet count ≥ 100,000 plts/mm3
- Total bilirubin ≤ 1.5ULN
- AST, ALT ≤ 2.5 ULN (if liver metastases(+): AST,ALT ≤5.0 x ULN)
- Serum chemistries within normal limits (WNL) or Grade 1 (excluding alkaline phosphatase) - If patients are diabetic or have a screening random glucose > 160 mg/dL, a fasting glucose must be done and patients must be WNL or Grade 1 in order to be eligible for the study.
- Written informed consent
Exclusion Criteria:
- Prior simvastatin therapy within 1-year from the date of study entry
- Severe or unstable cardiac disease, including (for example) coronary artery disease requiring increased doses of anti-anginal mediation and/or coronary angioplasty (including stent placement) within the preceding 24 months
- Current, known CNS malignancy (history of completely resected or irradiated brain metastases by WBRT or stereotactic radiosurgery allowed)
- Patients with CPK > 5 x ULN at baseline
- Patients with alcohol abuse
- Uncontrolled hypothyroidism
- Concomitant use with clarithromycin, erythromycin, itraconazole, ketoconazole, nefazodone, telithromycin
- Concomitant use of gemfibrozil, cyclosporine, danazol, amiodarone, verapamil

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01281761
Korea, Republic of | |
Samsung Medical Center | |
Seoul, Korea, Republic of, 135-710 |
Principal Investigator: | Won Ki Kang, MD | Samsung Medical Center |
Responsible Party: | Won Ki Kang, Professor, Samsung Medical Center |
ClinicalTrials.gov Identifier: | NCT01281761 History of Changes |
Other Study ID Numbers: |
SMC IRB 2010-08-006 |
First Posted: | January 24, 2011 Key Record Dates |
Last Update Posted: | June 14, 2013 |
Last Verified: | June 2013 |
Additional relevant MeSH terms:
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Irinotecan Camptothecin |
Cetuximab Simvastatin Antineoplastic Agents, Phytogenic Antineoplastic Agents Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors |