Bortezomib and Cetuximab in Treating Patients With Advanced Solid Tumors
NCT00622674 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 37
Last updated 2017-12-02
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
Interventions
- 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.
- 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.
Sponsors & Collaborators
-
Masonic Cancer Center, University of Minnesota
lead OTHER
Principal Investigators
-
Arkadiusz Dudek, MD · Masonic Cancer Center, University of Minnesota
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-11-30
- Primary Completion
- 2009-08-31
- Completion
- 2010-02-28
Countries
- United States
Study Locations
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