Clinical trial · Interventional
Bevacizumab, Fluorouracil, and Hydroxyurea Plus Radiation Therapy in Treating Patients With Advanced Head and Neck Cancer
A Phase I Study Of Bevacizumab (Recombinant Humanized Monoclonal Antibody To Vascular Endothelial Growth Factor) In Addition To Flourouracil And Hydroxyurea As Initial Chemotherapy With Concomitant Radiotherapy (B-FHX) For Poor Prognosis Head And Neck Cancer
- 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)
Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining monoclonal antibody therapy with chemotherapy and radiation therapy may be an effective treatment for head and neck cancer. This phase I trial is to see if combining bevacizumab, fluorouracil, and hydroxyurea with radiation therapy works in treating patients who have advanced head and neck cancer
Conditions
Conditions (54)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma | — | UNRESOLVED | — |
| Recurrent Adenoid Cystic Carcinoma of the Oral Cavity | Oral Cavity Adenoid Cystic Carcinoma | CURATED_BROADER | 0.78 |
| Recurrent Basal Cell Carcinoma of the Lip | Lip Basal Cell Carcinoma | CURATED_BROADER | 0.78 |
| Recurrent Esthesioneuroblastoma of the Paranasal Sinus and Nasal Cavity | — | UNRESOLVED | — |
| Recurrent Inverted Papilloma of the Paranasal Sinus and Nasal Cavity | — | UNRESOLVED | — |
| Recurrent Lymphoepithelioma of the Nasopharynx | Nasopharyngeal Undifferentiated Carcinoma | CURATED_BROADER | 0.78 |
| Recurrent Lymphoepithelioma of the Oropharynx |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bevacizumab | Biological | Bevacizumab | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| fluorouracil | Drug | Fluorouracil | ALIAS |
| hydroxyurea | Drug | Hydroxyurea | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (hydroxyurea, fluorouracil, bevacizumab, radiation)
- description
- Patients receive oral hydroxyurea every 12 hours on days 1-6, fluorouracil IV continuously on days 1-5, and bevacizumab IV over 90 minutes on day 1. Patients also undergo radiotherapy once daily on days 1-5. Patients receive G-CSF subcutaneously on days 6-12. Treatment repeats every 2 weeks for up to 7 courses in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: hydroxyurea
- Drug: fluorouracil
- Biological: bevacizumab
- Radiation: radiation therapy
- Biological: filgrastim
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- MTD defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity assessed using NCI CTCAE version 3.0
- timeFrame
- 14 weeks
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed advanced head and neck cancer * Requiring regional palliative radiotherapy * Not amenable to standard therapy * Previously untreated disease allowed only if prognosis is poor (i.e., estimated 2-year survival of less than 10% if treated with standard therapy alone) * No obvious tumor involvement of major vessels on CT scan * No known brain metastases * Performance status - ECOG 0-2 * Performance status - Karnofsky 60-100% * More than 12 weeks * WBC at least 3,000/mm\^3 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * No history of bleeding diathesis * Bilirubin normal * AST/ALT no greater than 2.5 times upper limit of normal * Creatinine normal * Urine protein no greater than trace * Urine protein less than 0.5 g/24 hours * No significant renal impairment * No symptomatic congestive heart failure * No cardiac arrhythmia * No deep venous thrombosis * No uncontrolled hypertension * No clinically significant peripheral artery disease * No arterial thromboembolic event within the past 6 months, including any of the following: * Transient ischemic attack * Cerebrovascular accident * Unstable angina * Myocardial infarction * No hemoptysis of at least 1 tablespoon * No history of allergic reactions attributed to compounds of similar chemical or biologic composition to bevacizumab or other agents used in this study * No non-healing wounds within the past 4 weeks * No significant ongoing or active infection * No other uncontrolled illness * No other severe complicating medical illness that would preclude study participation * No psychiatric illness or social situation that would preclude study compliance * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No prior fluorouracil and hydroxyurea with radiotherapy * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered * See Disease Characteristics * See Chemotherapy * At least 4 months since prior radiotherapy and recovered * At least 4 weeks since prior major surgery * No prior or concurrent chronic use of aspirin or other nonsteroidal anti-inflammatory agents * No other concurrent investigational agents * No concurrent anticoagulation therapy * No concurrent combination antiretroviral therapy for HIV-positive patients * No other concurrent anticancer agents
References
Publications (0)
Data not yet available