Cetuximab and Simvastatin in Treating Patients With Advanced or Metastatic Colorectal Cancer

NCT01190462 | Unknown Phase 2

• 5 other identifiers: DUT-LUMC-838CDR0000683942NL-30642-058-10EUDRACT-2009-017384-42EU-21065
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Simvastatin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Simvastatin may help cetuximab work better by making tumor cells more sensitive to cetuximab. Giving cetuximab together with simvastatin may kill more tumor cells. PURPOSE: This phase II trial is studying giving cetuximab together with simvastatin in treating patients with advanced or metastatic colorectal cancer.

Conditions

Colorectal Cancer

Keywords

recurrent colon cancer; stage III colon cancer; stage IV colon cancer; recurrent rectal cancer; stage III rectal cancer; stage IV rectal cancer

Outcome Measures

Primary Outcomes (1)

• Percentage of patients free from progression and alive after 12.5 weeks following the first dose of treatment

Secondary Outcomes (1)

• Correlation between overall response rate, progression-free survival, overall survival, and safety with skin toxicity and efficacy

Interventions

cetuximab BIOLOGICAL

simvastatin DRUG

laboratory biomarker analysis OTHER

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Diagnosis of advanced or metastatic colorectal cancer * Progressive disease in the past 3 months * Failed prior oxaliplatin-, fluorouracil (5-FU)-, and irinotecan-containing regimens AND have the presence of a k-ras mutation within codon 12, 13, or 61 PATIENT CHARACTERISTICS: * WHO performance status 0-2 * Adequate organ function * No history of toxicity during statin use * No other malignancy within the past 5 years * No history of severe pulmonary disease * No clinically relevant coronary artery disease PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior epidermal growth factor receptor (EGFR)-targeting agents * No concurrent verapamil or amiodarone

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Leiden University Medical Center: lead

Study Sites (2)

Amphia Ziekenhuis - locatie Langendijk

Breda, 4819 EV, Netherlands

RECRUITING

Leiden University Medical Center

Leiden, 2333 ZA, Netherlands

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Interventions

Cetuximab; 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)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Hans Gelderblom, MD, PhD

  Leiden University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 26, 2010
• First Posted: August 27, 2010
• Study Start: August 1, 2010
• Primary Completion: August 1, 2012
• Last Updated: August 12, 2013

Record last verified: 2011-04

Locations

NL (2)