Breast CancerPhase 1NCT00622674
Bortezomib and Cetuximab in Treating Patients With Advanced Solid Tumors
A Phase 1 study testing cetuximab and bortezomib in people with Breast Cancer and Colorectal Cancer, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial summary
RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Colorectal Cancer, Head and Neck Cancer
- What is being tested?
- cetuximab and bortezomib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to Feb 2010
- Phase
- Phase 1
- 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
Who may be able to join
- Diagnosis of solid tumor that overexpresses epidermal growth factor receptor (EGFR) including, but not limited to, the following:
- Breast cancer
- Lung cancer
- Colon cancer
- Pancreatic cancer
- Head and neck cancer
Show all 27Show fewer
- Kidney cancer
- Sarcoma
- Advanced disease
- Must have failed or become intolerant to prior standard therapy and is no longer likely to respond to such therapy
- Measurable or nonmeasurable disease
- ECOG performance status 0-1
- ANC ≥ 1,500/mm³
- Platelet count > 100,000/mm³
- Hemoglobin > 9 g/dL
- Bilirubin < 1.5 times upper limit of normal (ULN)
- Alkaline phosphatase < 3.0 times ULN (5.0 times ULN if liver has tumor involvement)
- Aspartate aminotransferase (AST) and alanine aminotransferase (*ALT) < 3.0 times upper limit of normal (ULN) (5.0 times ULN if liver has tumor involvement)
- Creatinine clearance > 30 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after completion of study treatment
- Recovered from all prior therapy
- Prior systemic chemotherapy, immunotherapy, or biological therapy allowed
- At least 14 days since prior radiotherapy or systemic therapy
- At least 30 days since prior investigational agents
- At least 14 days since other prior investigational drugs (for reasons other than the treatment of cancer)
Who cannot join
- Untreated or symptomatic central nervous system (CNS) metastases
- Concurrent serious systemic disorders (e.g., active infection) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient's ability to complete the study
- Uncontrolled diabetes
- Myocardial infarction within the past 6 months
- New York Heart Association (NYHA) class III or IV heart failure
- Uncontrolled angina
Show all 13Show fewer
- Severe uncontrolled ventricular arrhythmias
- Evidence of acute ischemia or active conduction system abnormalities by ECG
- Peripheral neuropathy Common Terminology Criteria for Adverse Events (CTCAE) grade > 2
- Known hypersensitivity to bortezomib, boron, or mannitol
- Serious medical or psychiatric illness likely to interfere with study participation
- Prior bortezomib and/or cetuximab
- Concurrent filgrastim (G-CSF) or other hematologic support during course 1 of study treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Phase I Study of Bortezomib (Velcade) and Cetuximab (Erbitux) for Patients With Solid Tumors Expressing EGFR
RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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. Giving bortezomib together with cetuximab may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib when given together with cetuximab in treating patients with advanced solid tumors.
Read the detailed description
OBJECTIVES:
Primary
- To determine the maximum tolerated dose of bortezomib when given together with cetuximab in patients with advanced solid tumors expressing epidermal growth factor receptor (EGFR).
Secondary
- To obtain preliminary information about the anti-tumor activity of bortezomib and cetuximab.
OUTLINE: This is a dose-escalation study of bortezomib.
Patients receive bortezomib intravenously (IV) on days 1 and 8 and cetuximab IV over 60-90 minutes on days 1, 8, and 15. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After the maximum tolerated dose (MTD) is determined, an additional 10 patients are treated at the MTD.
After completion of study treatment, patients are followed periodically for up to 1 year.
- Conditions
- Breast Cancer, Colorectal Cancer, Head and Neck Cancer, Kidney Cancer, Lung Cancer, Pancreatic Cancer
- Being tested
- cetuximab, bortezomib
- Keywords
- recurrent breast cancer, recurrent non-small cell lung cancer, recurrent small cell lung cancer, recurrent colon cancer, recurrent pancreatic cancer, recurrent head and neck cancer, recurrent sarcoma, recurrent kidney cancer, recurrent renal cell cancer
- Medical subject headings
- Breast Neoplasms, Colorectal Neoplasms, Head and Neck Neoplasms, Kidney Neoplasms, Lung Neoplasms, Pancreatic Neoplasms, Sarcoma, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cetuximabBiological
Also called Erbitux
A loading dose of cetuximab will be given on day 1 (400 mg/m2) followed by a weekly dose of 250 mg/m2.
bortezomibDrug
Also called Velcade
The starting dose of bortezomib will be 1.3 mg/m2 with a 0.1 increment increase with each successive dose level to a maximum of 2.0 mg/m2.
| Study group | Role | What they receive |
|---|---|---|
| Bortezomib and Cetuximab | Experimental | The starting dose of bortezomib will be 1.3 mg/m2 with a 0.1 increment increase with each successive dose level to a maximum of 2.0 mg/m2. A loading dose of cetuximab will be given on day 1 (400 mg/m2) followed by a weekly dose of 250 mg/m2. Receives: Biological: cetuximab; Drug: bortezomib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD) of bortezomib
The standard Phase I design will be used to determine the maximum tolerated dose of bortezomib when given with weekly cetuximab. The MTD is defined as the highest dose studied for which the incidence of dose limiting toxicity (DLT) was less than 33%.
Measured: At end of Cycle 1 (Week 3)
Secondary outcomes (1)
Disease response as measured by RECIST criteria
The best overall response is the best response recorded from registration until disease progression/recurrence, taking as reference for progressive disease the smallest measurements recorded since registration.
Measured: At Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2008 (estimated)
- Study startNov 2005
- Primary completionAug 2009
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arkadiusz Dudek, MD, Principal investigator, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00622674
- Sponsor's protocol ID
- CDR0000586671
- Other IDs
- UMN-2005LS037, MILLENNIUM-X05160, UMN-0506M7030372
- Status last verified
- Apr 2010
- First submitted
- 22 Feb 2008
- Last updated
- 2 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Bortezomib (Velcade) and Cetuximab (Erbitux) for Patients With Solid Tumors Expressing EGFR
- ClinicalTrials.gov ID
- NCT00622674
- Acronym / sponsor ID
- CDR0000586671
- Conditions
- Breast Cancer, Colorectal Cancer, Head and Neck Cancer, Kidney Cancer, Lung Cancer, Pancreatic Cancer
- Keywords
- recurrent breast cancer, recurrent non-small cell lung cancer, recurrent small cell lung cancer, recurrent colon cancer, recurrent pancreatic cancer, recurrent head and neck cancer, recurrent sarcoma, recurrent kidney cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- Nov 2005
- Primary completion
- Aug 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 25 Feb 2008 (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: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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. Giving bortezomib together with cetuximab may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib when given together with cetuximab in treating patients with advanced solid tumors.
Detailed description
OBJECTIVES:
Primary
- To determine the maximum tolerated dose of bortezomib when given together with cetuximab in patients with advanced solid tumors expressing epidermal growth factor receptor (EGFR).
Secondary
- To obtain preliminary information about the anti-tumor activity of bortezomib and cetuximab.
OUTLINE: This is a dose-escalation study of bortezomib.
Patients receive bortezomib intravenously (IV) on days 1 and 8 and cetuximab IV over 60-90 minutes on days 1, 8, and 15. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After the maximum tolerated dose (MTD) is determined, an additional 10 patients are treated at the MTD.
After completion of study treatment, patients are followed periodically for up to 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bortezomib and Cetuximab | Experimental | Biological: cetuximab, Drug: bortezomibThe starting dose of bortezomib will be 1.3 mg/m2 with a 0.1 increment increase with each successive dose level to a maximum of 2.0 mg/m2. A loading dose of cetuximab will be given on day 1 (400 mg/m2) followed by a weekly dose of 250 mg/m2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- Diagnosis of solid tumor that overexpresses epidermal growth factor receptor (EGFR) including, but not limited to, the following:
- Advanced disease
- Measurable or nonmeasurable disease
- ECOG performance status 0-1
- ANC ≥ 1,500/mm³
Key exclusion criteria (13 listed)
- Untreated or symptomatic central nervous system (CNS) metastases
- Concurrent serious systemic disorders (e.g., active infection) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient's ability to complete the study
- Uncontrolled diabetes
- Myocardial infarction within the past 6 months
- New York Heart Association (NYHA) class III or IV heart failure
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 |
|---|---|---|
| cetuximabAlso: ErbituxA loading dose of cetuximab will be given on day 1 (400 mg/m2) followed by a weekly dose of 250 mg/m2. | Biological | Bortezomib and Cetuximab |
| bortezomibAlso: VelcadeThe starting dose of bortezomib will be 1.3 mg/m2 with a 0.1 increment increase with each successive dose level to a maximum of 2.0 mg/m2. | Drug | Bortezomib and Cetuximab |
Primary outcome
Maximum tolerated dose (MTD) of bortezomib
Time frame: At end of Cycle 1 (Week 3)
The standard Phase I design will be used to determine the maximum tolerated dose of bortezomib when given with weekly cetuximab. The MTD is defined as the highest dose studied for which the incidence of dose limiting toxicity (DLT) was less than 33%.
1 secondary outcome
Disease response as measured by RECIST criteria
Time frame: At Week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2017.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Arkadiusz Dudek, MD principal investigator
Masonic Cancer Center, University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing cetuximab and bortezomib in people with Breast Cancer and Colorectal Cancer, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 27 inclusion and 13 exclusion criteria. 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: finished, as of the sponsor's last update on 2 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (MTD) of bortezomib (time frame: At end of Cycle 1 (Week 3)). 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 2 Dec 2017.