Cisplatin, Bevacizumab, and Intensity-Modulated Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer

Part of paid clinical trials in New York, New York.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT00423930
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • bevacizumab — BIOLOGICAL
  • cisplatin — DRUG
  • conventional surgery — PROCEDURE
  • intensity-modulated radiation therapy — RADIATION

Study Details

RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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 head and neck cancer by blocking blood flow to the tumor. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving cisplatin and bevacizumab together with intensity-modulated radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying the side effects and how well giving cisplatin and bevacizumab together with intensity-modulated radiation therapy works in treating patients with stage III or stage IV head and neck cancer.

Key Dates

First listed
Jan 18, 2007
Start date
Oct 31, 2006
Status verified
Jul 2017
Primary completion
Jul 31, 2016
Completion
Jul 31, 2016

Study Design

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

Arms

  • Experimental: IMRT + cisplatin + bevacizumab
    This is a single-institution phase II study. The primary endpoint is to determine 2-year progression-free survival for patients with locally or regionally advanced HNSCC treated with concurrent intensity modulated radiation therapy (IMRT) + cisplatin + bevacizumab.

Primary Outcome Measure

Progression-free Survival at 2 Years [ Time Frame: Percentage of Participants Experiencing Progression-free Survival at 2 Years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Memorial Sloan-Kettering Cancer CenterNew YorkNew York10065-

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