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NCT00329589 Clinical Trial

A Trial Using Velcade Plus Chemoradiation for Central Nervous System, Head and Neck, and Cervical Cancer Patients

Head and Neck Cancer Clinical Trial

Official title:
A Phase I Open-labeled, Dose-escalation, Safety Study of the Combination of Velcade and Chemoradiation for the Treatment of Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00329589
Other study ID # 05C.255
Secondary ID 2005-28NCI-2009-
Status Completed
Phase Phase 1
First received May 24, 2006
Last updated May 5, 2017
Start date September 2005
Est. completion date June 2010

Study information
Verified date May 2017
Source Thomas Jefferson University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine the safety of Velcade when used with chemoradiation in cancer patients.

Description:

- To determine the maximum tolerated dose (MTD) and a recommended phase II dose (RP2D) of Velcade® when administered as a twice weekly 3-5 second IV bolus every 3 weeks to patients with malignancies of the brain, head and neck and cervix who receive 2-8 weeks of chemoradiation.

- To evaluate the safety and toxicity profile of Velcade® when administered on a twice weekly (days 1, 4, 8 and 11) every 3 weeks (maximum 8 weeks) concurrent with chemoradiation.

- To evaluate tumor response

Recruitment information / eligibility
Status Completed
Enrollment 54
Est. completion date June 2010
Est. primary completion date June 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Histologically confirmed malignancy

- Requiring at least grade 2 weeks of radiation therapy

- Solid tumors of the central nervous system, head and neck area, and cervix

- World Health Organization (WHO) performance status equal to or less than 2

Exclusion Criteria:

- Equal to or greater than grade 2 peripheral neuropathy

- Myocardial infarction within 6 months

- Hypersensitivity to bortezomib, boron, or mannitol

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Velcade (bortezomib)

Locations
Country Name City State
United States Thomas Jefferson University Hospital Philadelphia Pennsylvania

Sponsors (2)
Lead Sponsor Collaborator
Sidney Kimmel Cancer Center at Thomas Jefferson University Millennium Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary To determine the safe and maximum tolerated dose of Velcade® when administered as a twice weekly 3-5 second intravenous (IV) bolus every 3 weeks to patients with malignancies of the brain, head and neck, and cervix who receive 2-8 weeks of radiotherapy 2-8 weeks
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