Clinical trial · Interventional
Phase I of Biologics and Chemoradiation Therapy for Advanced Head and Neck Cancer
A Phase I Study of the Combination of Chemoradiotherapy With Biologic Therapy for Advanced Head and Neck Cancer
NCT00405405CI-TRIAL-00089365completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| Parotid Gland Cancer | Malignant Parotid Gland Neoplasm | CURATED_BROADER | 0.80 |
| Stage IV Head and Neck Cancer | Malignant Head and Neck Neoplasm | CURATED_BROADER | 0.78 |
| Thyroid Gland Cancer | Malignant Thyroid Gland Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
| Erlotinib | Drug | Erlotinib | ALIAS |
| Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment
- description
- A combination of Cisplatin, Docetaxel, Bevacizumab, Erlotinib, and Radiotherapy
- interventionNames
- Drug: Cisplatin
- Drug: Docetaxel
- Drug: Bevacizumab
- Drug: Erlotinib
- Radiation: Radiotherapy
Primary outcomes (1)
- measure
- Bevacizumab and Erlotinib Combined with Chemoradiotherapy for the Treatment of Advanced Head and Neck Cancer
- timeFrame
- Day 36
- description
- To determine if bevacizumab and erlotinib can be safely combined with chemoradiotherapy for advanced head and neck cancer.
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 peripheral vascular disease. * Evidence of bleeding diathesis or coagulopathy. * Presence of brain or spinal cord metastases. * Major surgical procedure(s), open biopsy or significant traumatic injury within 28 days prior to Day 1 (1st day of study treatment) and/or anticipation of need for major surgical procedure during the course of the study. * Urine protein: Creatinine ratio \> or = 1.0 at screening.\* * Carotid artery exposure or other signs of impending carotid artery hemorrhage. * History of abdominal fistula and/or gastrointestinal abdominal abscess within 6 months prior to enrollment. * Serious, non-healing wound, ulcer, or bone fracture. * Prior irradiation that would result in radiotherapy field "overlap." * Requirement for high dose oral anticoagulation (i.e., goal INR \> 2.0). "Mini-dose" anticoagulation as may be used to assist in patency of central venous lines is acceptable. Subcutaneous Low-molecular weight heparin is allowable. * No known allergies to any of the drug therapies being used in this protocol. * No pregnancy, lactation or inability to use medically acceptable birth control if of childbearing potential.
References
Publications (0)
Data not yet available
No reference posted for this study.