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Phase I Study of Bortezomib (Velcade) and Cetuximab (Erbitux) for Patients With Solid Tumors Expressing EGFR

Phase 1
18 Years
Not Enrolling
Breast Cancer, Colorectal Cancer, Head and Neck Cancer, Kidney Cancer, Lung Cancer, Pancreatic Cancer, Sarcoma, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Phase I Study of Bortezomib (Velcade) and Cetuximab (Erbitux) for Patients With Solid Tumors Expressing EGFR



- 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).


- To obtain preliminary information about the anti-tumor activity of bortezomib and

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.

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 >

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose (MTD) of bortezomib

Outcome Description:

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%.

Outcome Time Frame:

At end of Cycle 1 (Week 3)

Safety Issue:


Principal Investigator

Arkadiusz Dudek, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Masonic Cancer Center, University of Minnesota


United States: Food and Drug Administration

Study ID:




Start Date:

November 2005

Completion Date:

February 2010

Related Keywords:

  • Breast Cancer
  • Colorectal Cancer
  • Head and Neck Cancer
  • Kidney Cancer
  • Lung Cancer
  • Pancreatic Cancer
  • Sarcoma
  • Unspecified Adult Solid Tumor, Protocol Specific
  • 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
  • Breast Neoplasms
  • Carcinoma, Renal Cell
  • Kidney Neoplasms
  • Colorectal Neoplasms
  • Head and Neck Neoplasms
  • Lung Neoplasms
  • Pancreatic Neoplasms
  • Neoplasms
  • Sarcoma



Masonic Cancer Center at University of Minnesota Minneapolis, Minnesota  55455