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Bortezomib and Cetuximab in Treating Patients With Advanced Solid Tumors

Primary Purpose

Breast Cancer, Colorectal Cancer, Head and Neck Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
cetuximab
bortezomib
Sponsored by
Masonic Cancer Center, University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Masonic Cancer Center at University of Minnesota

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bortezomib and Cetuximab

Arm Description

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.

Outcomes

Primary Outcome Measures

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%.

Secondary Outcome Measures

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.

Full Information

First Posted
February 22, 2008
Last Updated
November 29, 2017
Sponsor
Masonic Cancer Center, University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT00622674
Brief Title
Bortezomib and Cetuximab in Treating Patients With Advanced Solid Tumors
Official Title
Phase I Study of Bortezomib (Velcade) and Cetuximab (Erbitux) for Patients With Solid Tumors Expressing EGFR
Study Type
Interventional

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Masonic Cancer Center, University of Minnesota

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Colorectal Cancer, Head and Neck Cancer, Kidney Cancer, Lung Cancer, Pancreatic Cancer, Sarcoma, Unspecified Adult Solid Tumor, Protocol Specific
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bortezomib and Cetuximab
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
cetuximab
Other Intervention Name(s)
Erbitux
Intervention Description
A loading dose of cetuximab will be given on day 1 (400 mg/m2) followed by a weekly dose of 250 mg/m2.
Intervention Type
Drug
Intervention Name(s)
bortezomib
Other Intervention Name(s)
Velcade
Intervention Description
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.
Primary Outcome Measure Information:
Title
Maximum tolerated dose (MTD) of bortezomib
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%.
Time Frame
At end of Cycle 1 (Week 3)
Secondary Outcome Measure Information:
Title
Disease response as measured by RECIST criteria
Description
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.
Time Frame
At Week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arkadiusz Dudek, MD
Organizational Affiliation
Masonic Cancer Center, University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
Masonic Cancer Center at University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

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Bortezomib and Cetuximab in Treating Patients With Advanced Solid Tumors

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