Phase 2 N=60 Treatment

Treatment of Head & Neck Cancer With Chemotherapy and Radiation

Head and Neck Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00392704 ↗

Enrolled (actual)

Serious AEs

40.0%

Results posted

Feb 2013

Primary outcome: Primary: 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 — 83 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Bevacizumab (Drug); Erlotinib (Drug); Paclitaxel (Drug); 5-FU (Drug); Radiation Therapy (Radiation)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: SCRI Development Innovations, LLC
Primary completion: Aug 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY 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	83	—
SECONDARY Overall Survival (OS)Probability, the Percentage of Patients Estimated to be Alive Two Years After Beginning Protocol Treatment	90	—

Summary

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00392704). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.