Breast Cancer Clinical Trial

Bortezomib and Cetuximab in Treating Patients With Advanced Solid Tumors

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. 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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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
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:

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
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

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

37

Study ID:

NCT00622674

Recruitment Status:

Completed

Sponsor:

Masonic Cancer Center, University of Minnesota

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There is 1 Location for this study

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Masonic Cancer Center at University of Minnesota
Minneapolis Minnesota, 55455, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

37

Study ID:

NCT00622674

Recruitment Status:

Completed

Sponsor:


Masonic Cancer Center, University of Minnesota

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