Bevacizumab, Fluorouracil, and Hydroxyurea Plus Radiation Therapy in Treating Patients With Advanced Head and Neck Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Antibodies; Antibodies, Monoclonal; Antineoplastic Agents, Immunological; Bevacizumab; Endothelial Growth Factors; Fluorouracil; Hydroxyurea; Immunoglobulins

Criteria

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