Colorectal CancerPhase 2NCT01190462
Cetuximab and Simvastatin in Treating Patients With Advanced or Metastatic Colorectal Cancer
A Phase 2 study testing cetuximab, simvastatin and laboratory biomarker analysis in people with Colorectal Cancer, run by Leiden University Medical Center at 2 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- cetuximab, simvastatin and laboratory biomarker analysis
- How many people
- 51 participants
- Where
- 2 sitesNetherlands
- Study dates
- Aug 2010to Aug 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites, 2 recruiting
- Recruiting
Amphia Ziekenhuis - locatie Langendijk
Breda, 4819 EV
Contact Person, 31-76-595-5000
- Recruiting
Leiden University Medical Center
Leiden, 2333 ZA
Contact Person, 31-71-526-3486
About this study
Official title: Safety and Efficacy of the Addition of Simvastatin to Cetuximab in K-ras Mutant Advanced or Metastatic Colorectal Cancer Patients. A Single-Arm, Multicenter, Phase II Study Using a Simon Two Stage Design.
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.
Read the detailed description
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
- Colorectal Cancer
- Being tested
- cetuximab, simvastatin, laboratory biomarker analysis
- Keywords
- recurrent colon cancer, stage III colon cancer, stage IV colon cancer, recurrent rectal cancer, stage III rectal cancer, stage IV rectal cancer
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cetuximabBiological
simvastatinDrug
laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionAug 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Masking
- None (open label)
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Hans Gelderblom, MD, PhD, Principal investigator, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01190462
- Sponsor's protocol ID
- DUT-LUMC-838
- Other IDs
- CDR0000683942, NL-30642-058-10, EUDRACT-2009-017384-42, EU-21065
- Status last verified
- Apr 2011
- First submitted
- 26 Aug 2010
- Last updated
- 12 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of the Addition of Simvastatin to Cetuximab in K-ras Mutant Advanced or Metastatic Colorectal Cancer Patients. A Single-Arm, Multicenter, Phase II Study Using a Simon Two Stage Design.
- ClinicalTrials.gov ID
- NCT01190462
- Acronym / sponsor ID
- DUT-LUMC-838
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Aug 2012 (estimated)
- First posted
- 27 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cetuximab | Biological | – |
| simvastatin | Drug | – |
| laboratory biomarker analysis | Other | – |
Primary outcome
Percentage of patients free from progression and alive after 12.5 weeks following the first dose of treatment
1 secondary outcome
Correlation between overall response rate, progression-free survival, overall survival, and safety with skin toxicity and efficacy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans Gelderblom, MD, PhD principal investigator
Leiden University Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cetuximab, simvastatin and laboratory biomarker analysis in people with Colorectal Cancer, run by Leiden University Medical Center at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients free from progression and alive after 12.5 weeks following the first dose of treatment. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2013.