Bortezomib and Cetuximab in Treating Patients With Advanced Solid Tumors

NCT00622674 | Completed Phase 1 DMC

• 4 other identifiers: CDR0000586671UMN-2005LS037MILLENNIUM-X05160UMN-0506M7030372
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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%.

  At end of Cycle 1 (Week 3)

Secondary Outcomes (1)

• Disease response as measured by RECIST criteria

  At Week 4

Study Arms (1)

Bortezomib and Cetuximab

EXPERIMENTAL

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; Drug: bortezomib

Interventions

cetuximab BIOLOGICAL

A loading dose of cetuximab will be given on day 1 (400 mg/m2) followed by a weekly dose of 250 mg/m2.

Also known as: Erbitux

Bortezomib and Cetuximab

bortezomib DRUG

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.

Also known as: Velcade

Bortezomib and Cetuximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead

Study Sites (1)

Masonic Cancer Center at University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Colorectal Neoplasms; Head and Neck Neoplasms; Kidney Neoplasms; Lung Neoplasms; Pancreatic Neoplasms; Sarcoma; Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma; Colonic Neoplasms; Carcinoma, Renal Cell

Interventions

Cetuximab; Bortezomib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Carcinoma, Bronchogenic; Bronchial Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Arkadiusz Dudek, MD

  Masonic Cancer Center, University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2008
• First Posted: February 25, 2008
• Study Start: November 1, 2005
• Primary Completion: August 1, 2009
• Study Completion: February 1, 2010
• Last Updated: December 2, 2017

Record last verified: 2010-04

Locations

US (1)