Bevacizumab, Docetaxel, and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Case Comprehensive Cancer Center
Study ID
NCT00281840
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • bevacizumab — BIOLOGICAL
    Bevacizumab IV over 30-90 minutes once every 2 weeks for up to 1 year. Bevacizumab, which stops 8 weeks before surgery, may restart 4 weeks after surgery and continue for 9 months in the absence of disease progression or unacceptable toxicity.
  • docetaxel — DRUG
    docetaxel IV over 1 hour once a week for 8 weeks
  • conventional surgery — PROCEDURE
    8-10 weeks after the completion of chemoradiotherapy, patients may undergo neck dissection
  • radiation therapy — RADIATION
    radiotherapy once daily, 5 days a week, for 8 weeks

Study Details

RATIONALE: Monoclonal antibodies, such as bevacizumab, 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. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving bevacizumab together with docetaxel and radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving bevacizumab together with docetaxel and radiation therapy works in treating patients with stage III or stage IV head and neck cancer.

Key Dates

First listed
Jan 25, 2006
Start date
Sep 30, 2005
Status verified
May 2015
Primary completion
Apr 30, 2012
Completion
Dec 31, 2012

Study Design

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

Arms

  • Experimental: bevacizumab with docetaxel and radiation therapy

Primary Outcome Measure

Time to Progression [ Time Frame: 5 yrs after treatment ]

Locations (6)

FacilityCityStateZIPSite coordinators
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer CenterClevelandOhio44106-5065-
Lake/University Ireland Cancer CenterMentorOhio44060-
Southwest General Health CenterMiddleburg HeightsOhio44130-
UHHS Chagrin Highlands Medical CenterOrange VillagerOhio44122-
UHHS Westlake Medical CenterWestlakerOhio44145-
UPMC Cancer CentersPittsburghPennsylvania15232-

Find similar trials in Cleveland, OH

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center· Cleveland, OHLake/University Ireland Cancer Center· Mentor, OHSouthwest General Health Center· Middleburg Heights, OHUHHS Chagrin Highlands Medical Center· Orange Villager, OHUHHS Westlake Medical Center· Westlaker, OHUPMC Cancer Centers· Pittsburgh, PA

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