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Bevacizumab, Fluorouracil, and Hydroxyurea Plus Radiation Therapy in Treating Patients With Advanced Head and Neck Cancer Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Bevacizumab, Fluorouracil, and Hydroxyurea Plus Radiation Therapy in Treating Patients With Advanced Head and Neck Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Bevacizumab, Fluorouracil, and Hydroxyurea Plus Radiation Therapy in Treating Patients With Advanced Head and Neck Cancer Clinical research trials and Bevacizumab, Fluorouracil, and Hydroxyurea Plus Radiation Therapy in Treating Patients With Advanced Head and Neck Cancer health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Bevacizumab, Fluorouracil, and Hydroxyurea Plus Radiation Therapy in Treating Patients With Advanced Head and Neck Cancer. Bevacizumab, Fluorouracil, and Hydroxyurea Plus Radiation Therapy in Treating Patients With Advanced Head and Neck Cancer Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Bevacizumab, Fluorouracil, and Hydroxyurea Plus Radiation Therapy in Treating Patients With Advanced Head and Neck Cancer clinical trial. Human subjects often get the best healthcare possible for their Bevacizumab, Fluorouracil, and Hydroxyurea Plus Radiation Therapy in Treating Patients With Advanced Head and Neck Cancer condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "B" Clinical Trials Conditions > Bevacizumab, Fluorouracil, and Hydroxyurea Plus Radiation Therapy in Treating Patients With Advanced Head and Neck Cancer  Bevacizumab, Fluorouracil, and Hydroxyurea Plus Radiation Therapy in Treating Patients With Advanced Head and Neck Cancer
Bevacizumab, Fluorouracil, and Hydroxyurea Plus Radiation Therapy in Treating Patients With Advanced Head and Neck Cancer
For Condition: Head and Neck Cancer
Status: Recruiting
Sponsor(s): University of Chicago Cancer Research Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Monoclonal antibodies such as bevacizumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use 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. PURPOSE: Phase I trial to study the effectiveness of combining bevacizumab, fluorouracil, and hydroxyurea with radiation therapy in treating patients who have advanced head and neck cancer.
Details: OBJECTIVES: - Determine the maximum tolerated dose and dose-limiting toxicity of bevacizumab when given in combination with fluorouracil, hydroxyurea, and radiotherapy in patients with advanced head and neck cancer. - Determine the time to progression, pattern of failure, local control, and distant failure rate in patients treated with this regimen. - Determine the local toxic effects of this regimen in these patients. OUTLINE: This is a multicenter, dose-escalation study of bevacizumab. 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 filgrastim (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. Cohorts of 3-6 patients receive escalating doses of bevacizumab until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Additional patients are treated at the MTD. PROJECTED ACCRUAL: A total of 27-39 patients will be accrued for this study within 5.4-19.5 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - 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 PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 OR - Karnofsky 60-100% Life expectancy: - More than 12 weeks Hematopoietic: - 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 Hepatic: - Bilirubin normal - AST/ALT no greater than 2.5 times upper limit of normal Renal: - Creatinine normal - Urine protein no greater than trace OR - Urine protein less than 0.5 g/24 hours - No significant renal impairment Cardiovascular: - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia - No deep venous thrombosis - No uncontrolled hypertension Pulmonary: - No hemoptysis of at least 1 tablespoon Other: - 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 PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior fluorouracil and hydroxyurea with radiotherapy - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered Endocrine therapy: - Not specified Radiotherapy: - See Disease Characteristics - See Chemotherapy - At least 4 months since prior radiotherapy and recovered Surgery: - At least 4 weeks since prior major surgery Other: - 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DavidGustin, Study Chair, University of Chicago Cancer Research Center
Robert H. Lurie Comprehensive Cancer Center at Northwestern University *Recruiting*
Chicago, Illinois, 60611-3013
United States
Recruiting Athanassios Argiris 312-695-4441
Evanston Northwestern Health Care - Evanston Hospital *Recruiting*
Evanston, Illinois, 60201-1781
United States
Recruiting Bruce Brockstein 847-570-2515
Central Illinois Hematology Oncology Center *Recruiting*
Springfield, Illinois, 62701
United States
Recruiting Edem Agamah 217-525-2500
University of Chicago Cancer Research Center *Recruiting*
Chicago, Illinois, 60637-1470
United States
Recruiting David Gustin 773-834-8634
Additional Information:
Study ID Numbers: CDR0000068879; NCI-2630,UCCRC-11033
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00023959
Other Head And Neck Cancer Studies:
1. Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer
2. Photodynamic Therapy System for Patients with Refractory/Unresponsive Solid Tumors
3. Gefitinib in Treating Patients With Recurrent and/or Metastatic Head and Neck Cancer
4. Phase II Trial of Allovectin-7® for Head and Neck Cancer
5. Capecitabine Combined with Cisplatin in Treating Patients With Locally Advanced or Metastatic Solid Tumors
Related Studies:
Other Head and Neck Cancer Clinical Trials
Other Illinois Clinical Trials
Other Springfield Clinical Trials
Bevacizumab, Fluorouracil, and Hydroxyurea Plus Radiation Therapy in Treating Patients With Advanced Head and Neck Cancer
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