Treatment of Head & Neck Cancer With Chemotherapy and Radiation

SCRI Development Innovations, LLC60 enrolled

Overview

Two new cancer treatment drugs called targeted therapies will be added to standard treatment for head and neck cancer to see if an improvement can be made in the effectiveness of treatment for this type of cancer. Treatment will include chemotherapy, radiation therapy and targeted therapy taken over a period of 4 months.

In this trial, patients will receive induction treatment with combination chemotherapy(paclitaxel/carboplatin/infusional 5FU) plus bevacizumab. After 6 weeks of treatment, patients will be reevaluated and will then receive concurrent radiation therapy, chemotherapy (weekly paclitaxel),bevacizumab, and erlotinib. Induction Treatment: Paclitaxel 200mg/m2 by vein over 1-3 hours on Day 1 \& Day 22 Carboplatin AUC 6.0 by vein over 1 hour on Days 1 and 22 Bevacizumab 15mg/kg by vein over 60-90 minutes on Days 1 and 22 5-FU 200mg/m2 as a 24 hour continuous infusion via pump on Days 1 through 43. Combined Modality Treatment: Radiation therapy is given daily, Monday through Friday for approximately 7 weeks. Erlotinib 150mg by mouth daily during the entire course of radiation (approximately 7 weeks) Paclitaxel 50mg/m2 by vein over 1-hour weekly for 6 weeks beginning Day 1 of radiation therapy Bevacizumab 15mg/kg by vein over 30-90 minutes on Days 50 and 71 at the same time of radiation therapy

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Head and Neck Cancer

Interventions

BevacizumabDRUG

Induction Treatment: Paclitaxel 200mg/m2 by vein over 1-3 hours on Day 1 \& Day 22 Carboplatin AUC 6.0 by vein over 1 hour on Days 1 and 22 Bevacizumab 15mg/kg by vein over 60-90 minutes on Days 1 and 22 5-FU 200mg/m2 as a 24 hour continuous infusion via pump on Days 1 through 43. Combined Modality Treatment: Radiation therapy is given daily, Monday through Friday for approximately 7 weeks. Erlotinib 150mg by mouth daily during the entire course of radiation (approximately 7 weeks) Paclitaxel 50mg/m2 by vein over 1-hour weekly for 6 weeks beginning Day 1 of radiation therapy Bevacizumab 15mg/kg by vein over 30-90 minutes on Days 50 and 71 at the same time of radiation therapy

ErlotinibDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Clinically confirmed head \& neck cancer * Considered low cure rate with local therapy * No prior treatment for this cancer * Able to be up \& about and perform self care * Adequate renal and liver function * Must be 18 years of age or older * All patients will need an indwelling central venous access catheter * Must be able to give written informed consent Exclusion Criteria: * Active cancer treatment in the last 5 years * Pregnant or lactating women * History of stroke, transient ischemic attacks, or acute myocardial infarction within the past 6 months or any other serious cardiovascular disease * History of neurological disease * Recent history of blood in the sputum or vomitus * Non-healing wounds, ulcer or long bone fractures * History of bleeding problems or coagulation problems * History of abdominal fistula, gastrointestinal perforation or intrabdominal abscess within 6 months * History of uncontrolled hypertension * Symptomatic peripheral vascular disease Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have. You can then decide if you wish to participate.

Locations (7)

Florida Cancer Specialists

Fort Myers, Florida, United States

Watson Clinic Center for Cancer Care and Research

Lakeland, Florida, United States

Florida Hospital Cancer Institute

Orlando, Florida, United States

Center for Cancer and Blood Disorders

Bethesda, Maryland, United States

Outcomes

Primary Outcomes

Two-Year Progression Free Survival (PFS) Probability, the Percentage of Patients Estimated to be Alive Without Worsening of Their Disease Two Years After Beginning Protocol Treatment

The percentage of patients estimated to be alive 2 years after beginning protocol treatment

Time frame: 24 months

Secondary Outcomes

Overall Survival (OS)Probability, the Percentage of Patients Estimated to be Alive Two Years After Beginning Protocol Treatment

The Percentage of Patients Estimated to be Alive Two Years After Beginning Protocol Treatment

Time frame: 24 Months

Data from ClinicalTrials.gov

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