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

NCT ID: NCT01190462

Last Updated: 2013-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Brief Summary

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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.

Detailed Description

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OBJECTIVES:

Primary

* To determine the percentage of patients with k-ras mutant, advanced or metastatic colorectal cancer who are free from progression and alive after 12.5 weeks following the first dose of cetuximab in combination with simvastatin.

Secondary

* To determine the correlation between overall response rate, progression-free survival, overall survival, and safety with skin toxicity and efficacy.
* To determine the predictive value of PTEN, PIK3CA, b-raf, and ERK and MEK status. (exploratory)
* To determine the predictive value of SNPs, proteomics, and circulating DNA. (exploratory)
* To evaluate cholesterol, proteomics, and circulating DNA as biomarkers in this setting. (exploratory)

OUTLINE: This is a multicenter study.

Patients receive cetuximab IV weekly and oral simvastatin once daily on days 1-7. Courses repeat every 7 days in the absence of disease progression or unacceptable toxicity.

Blood samples are collected for laboratory studies at baseline, during study, and after completion of study.

After completion of study therapy, patients are followed up for 30 days.

Conditions

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Colorectal Cancer

Keywords

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

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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cetuximab

Intervention Type BIOLOGICAL

simvastatin

Intervention Type DRUG

laboratory biomarker analysis

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Leiden University Medical Center

OTHER

Sponsor Role lead

Principal Investigators

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Hans Gelderblom, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Leiden University Medical Center

Locations

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Amphia Ziekenhuis - locatie Langendijk

Breda, , Netherlands

Site Status RECRUITING

Leiden University Medical Center

Leiden, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Facility Contacts

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Contact Person

Role: primary

Contact Person

Role: primary

Other Identifiers

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CDR0000683942

Identifier Type: REGISTRY

Identifier Source: secondary_id

NL-30642-058-10

Identifier Type: -

Identifier Source: secondary_id

EUDRACT-2009-017384-42

Identifier Type: -

Identifier Source: secondary_id

EU-21065

Identifier Type: -

Identifier Source: secondary_id

DUT-LUMC-838

Identifier Type: -

Identifier Source: org_study_id