Bortezomib and Cetuximab in Treating Patients With Advanced Solid Tumors
NCT ID: NCT00622674
Last Updated: 2017-12-02
Study Results
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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COMPLETED
PHASE1
37 participants
INTERVENTIONAL
2005-11-30
2010-02-28
Brief Summary
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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
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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
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Bortezomib and Cetuximab
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.
cetuximab
A loading dose of cetuximab will be given on day 1 (400 mg/m2) followed by a weekly dose of 250 mg/m2.
bortezomib
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.
Interventions
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cetuximab
A loading dose of cetuximab will be given on day 1 (400 mg/m2) followed by a weekly dose of 250 mg/m2.
bortezomib
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Breast cancer
* Lung cancer
* Colon cancer
* Pancreatic cancer
* Head and neck cancer
* 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)
Exclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Masonic Cancer Center, University of Minnesota
OTHER
Responsible Party
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Principal Investigators
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Arkadiusz Dudek, MD
Role: PRINCIPAL_INVESTIGATOR
Masonic Cancer Center, University of Minnesota
Locations
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Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States
Countries
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Other Identifiers
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UMN-2005LS037
Identifier Type: OTHER
Identifier Source: secondary_id
MILLENNIUM-X05160
Identifier Type: OTHER
Identifier Source: secondary_id
UMN-0506M7030372
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000586671
Identifier Type: -
Identifier Source: org_study_id