A Phase II Trial of Cetuximab and Bevacizumab in Patients With Recurrent or Metastatic Head and Neck Cancer

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00409565
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 98 Years
Healthy Volunteers
Not accepted

Interventions

  • Cetuximab — DRUG
    * Cetuximab 400 mg/m2 IV over 120 minutes on day 1 of cycle 1 ONLY * Cetuximab dose will be 250 mg/m2 IV over 60 minutes weekly on ALL subsequent administrations
  • Bevacizumab — DRUG
    Once every 3 weeks, 15 mg/kg of bevacizumab will be given by IV infusion after cetuximab has been given

Study Details

The purpose of this study is to determine if the combination of two new drugs, cetuximab (Erbitux) and bevacizumab (Avastin) can increase the effectiveness of treatment for head and neck cancer. Cetuximab has recently been approved by the FDA for head and neck cancer (that is locally or regionally advanced) when used in combination with radiation therapy. Cetuximab is also approved by the FDA for the treatment of colorectal cancer

Key Dates

First listed
Dec 11, 2006
Start date
Sep 30, 2006
Status verified
Sep 2017
Primary completion
Feb 29, 2012
Completion
Feb 29, 2012

Study Design

Enrollment
48 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cetuximab plus bevacizumab
    Cetuximab plus bevacizumab

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: Up to 5 years ]

Locations (4)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48109-0848-
Case Western Reserve UniversityClevelandOhio44106-
UPMC / UPMC Cancer CentersPittsburghPennsylvania15232-
University of Texas MD AndersonHoustonTexas77030-

Find similar trials in Ann Arbor, MI

By condition
Head and neck cancerSkin cancer
By specialty
OncologyENTSkin cancerDermatology
By research site
University of Michigan· Ann Arbor, MICase Western Reserve University· Cleveland, OHUPMC / UPMC Cancer Centers· Pittsburgh, PAUniversity of Texas MD Anderson· Houston, TX

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