Phase I of Biologics and Chemoradiation Therapy for Advanced Head and Neck Cancer (NCT00405405) | Clinical Trial Compass
CompletedPhase 1
Phase I of Biologics and Chemoradiation Therapy for Advanced Head and Neck Cancer
United States13 participantsStarted 2006-12
Plain-language summary
To determine a safe and effective doses of two biologic drugs, erlotinib and bevacizumab when used with chemotherapy and radiation therapy in advanced head and neck cancer
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Locally advanced Carcinoma (epithelial malignancy) of the head and neck. This may include non-squamous carcinomas (e.g. parotid, thyroid, melanoma) in which a large portion of mucosa of the oral cavity and/or laryngopharynx is expected to be irradiated.
* Stage IV disease (T4Nany or TanyN2-3).
* "Oligometastatic" disease is allowable if it is asymptomatic.
* Measurable disease is not required; patients who have had surgical resection are eligible provided that it is felt that the likelihood of cure with conventional postoperative therapy is \<40% and provided that there will be at least 28 days from the date of surgery to the start of study therapy.
* Performance status 0-1.
* Creatinine \< or = 1.5 mg/dl.
* ANC \> or = 1,800 cells/mm3.
* Platelets \> or = 150,000 cells/mm3.
* Hemoglobin \> or = 10 g/dl (transfusion is acceptable if needed).
* SGOT and/or SGPT \< or = 2.5 times the upper institutional limit of normal.
* INR \< or = 2.0.
* Age \> or = 18 (informed consent).
Exclusion Criteria:
* Current, recent (within 4 weeks of the Day 1, the first infusion of drug in this study) or planned participation in an experimental drug study other than this one.
* Poorly controlled blood pressure, defined as systolic bp \> 150 and/or diastolic bp \> 100 despite medication.
* Unstable angina.
* NY Heart Association (NYHA) Grade II or greater congestive heart failure.
* History of myocardial infarction or stroke within 6 months.
* Clinically significant periph…
What they're measuring
1
Bevacizumab and Erlotinib Combined with Chemoradiotherapy for the Treatment of Advanced Head and Neck Cancer
Timeframe: Day 36
Trial details
NCT IDNCT00405405
SponsorSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University