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Bortezomib and Cetuximab in Treating Patients With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT00622674
Recruitment Status : Completed
First Posted : February 25, 2008
Last Update Posted : December 1, 2017
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Colorectal Cancer Head and Neck Cancer Kidney Cancer Lung Cancer Pancreatic Cancer Sarcoma Unspecified Adult Solid Tumor, Protocol Specific Biological: cetuximab Drug: bortezomib Phase 1

Detailed Description:



  • 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 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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of Bortezomib (Velcade) and Cetuximab (Erbitux) for Patients With Solid Tumors Expressing EGFR
Study Start Date : November 2005
Primary Completion Date : August 2009
Study Completion Date : February 2010

Arms and Interventions

Arm Intervention/treatment
Experimental: 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.
Biological: cetuximab
A loading dose of cetuximab will be given on day 1 (400 mg/m2) followed by a weekly dose of 250 mg/m2.
Other Name: Erbitux
Drug: 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 Name: Velcade

Outcome Measures

Primary Outcome Measures :
  1. 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%.

Secondary Outcome Measures :
  1. Disease response as measured by RECIST criteria [ Time Frame: At Week 4 ]
    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.

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00622674

United States, Minnesota
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Principal Investigator: Arkadiusz Dudek, MD Masonic Cancer Center, University of Minnesota
More Information

Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT00622674     History of Changes
Other Study ID Numbers: CDR0000586671
UMN-2005LS037 ( Other Identifier: CPRC, University of Minnesota )
MILLENNIUM-X05160 ( Other Identifier: Millennium Pharm Inc. )
UMN-0506M7030372 ( Other Identifier: IRB, University of Minnesota )
First Posted: February 25, 2008    Key Record Dates
Last Update Posted: December 1, 2017
Last Verified: April 2010

Keywords provided by Masonic Cancer Center, University of Minnesota:
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

Additional relevant MeSH terms:
Lung Neoplasms
Colorectal Neoplasms
Pancreatic Neoplasms
Head and Neck Neoplasms
Kidney Neoplasms
Carcinoma, Renal Cell
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Urologic Neoplasms
Urogenital Neoplasms
Kidney Diseases
Urologic Diseases