Phase 2
Completed N=60
Treatment of Head & Neck Cancer With Chemotherapy and Radiation
Source: ClinicalTrials.gov NCT00392704 ↗Enrolled (actual)
60
Serious AEs
40.0%
Results posted
Feb 2013
Primary outcomePrimary: 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
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.
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 | — |
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.
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. Informational only — not medical advice.