|
Bevacizumab and Erlotinib in Treating Patients With Recurrent or Metastatic Head and Neck Cancer Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about Bevacizumab and Erlotinib in Treating Patients With Recurrent or Metastatic Head and Neck Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Bevacizumab and Erlotinib in Treating Patients With Recurrent or Metastatic Head and Neck Cancer Clinical research trials and Bevacizumab and Erlotinib in Treating Patients With Recurrent or Metastatic Head and Neck Cancer health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like Bevacizumab and Erlotinib in Treating Patients With Recurrent or Metastatic Head and Neck Cancer. Bevacizumab and Erlotinib in Treating Patients With Recurrent or Metastatic Head and Neck Cancer Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a Bevacizumab and Erlotinib in Treating Patients With Recurrent or Metastatic Head and Neck Cancer clinical trial. Human subjects often get the best healthcare available for their Bevacizumab and Erlotinib in Treating Patients With Recurrent or Metastatic Head and Neck Cancer condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "B" Clinical Trials Conditions > Bevacizumab and Erlotinib in Treating Patients With Recurrent or Metastatic Head and Neck Cancer  Bevacizumab and Erlotinib in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
Bevacizumab and Erlotinib in Treating Patients With Recurrent or Metastatic 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: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Monoclonal antibodies such as bevacizumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining erlotinib with bevacizumab may kill more tumor cells. PURPOSE: Randomizedphase I/II trial to study the effectiveness of combining erlotinib with bevacizumab in treating patients who have recurrent or metastatic head and neck cancer.
Details: OBJECTIVES: - Determine the maximum tolerated dose and dose-limiting toxicity of bevacizumab when administered with erlotinib in patients with recurrent or metastatic head and neck cancer. - Determine the objective response rate and stable disease/absence of early progression in patients treated with this regimen. OUTLINE: This is a dose-escalation study of bevacizumab followed by a randomized, multicenter study. - Patients receive bevacizumab IV over 30-90 minutes on day 1 and oral erlotinib on days 1-21. Courses repeat every 21 days 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 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. - Course 1 is 28 days in length. All subsequent courses are 21 days. - Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive bevacizumab IV over 30-90 minutes on day 14 and oral erlotinib on days 1-28. - Arm II: Patients receive bevacizumab IV over 30-90 minutes on day 1 and oral erlotinib on days 1-28. - All subsequent courses: All patients receive bevacizumab as in arm II and oral erlotinib on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 9-18 patients will be accrued for the phase I portion of this study within 2-9 months and 40 patients for the phase II portion of this study within 8-20 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed squamous cell cancer of the head and neck - Recurrent or metastatic disease - Determined to be incurable by surgery or radiotherapy - Measurable disease - No tumor involvement encasing or too close in proximity to a major artery or vein - No known brain metastases - No prior or concurrent CNS disease - No primary brain tumor PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 OR - Karnofsky 60-100% Life expectancy - More than 12 weeks Hematopoietic - No history of bleeding diathesis - WBC at least 3,000/mm^3 - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - INR less than 1.5 - Bilirubin normal - AST and ALT no greater than 2.5 times upper limit of normal Renal - Creatinine normal OR - Creatinine clearance at least 60 mL/min - No significant renal impairment - 24-hour urinary protein less than 0.5 g required if more than trace proteinuria at baseline Cardiovascular - No uncontrolled hypertension - No symptomatic congestive heart failure - No unstable angina pectoris - No serious cardiac arrhythmia requiring medication - No deep venous thrombosis - No prior stroke - No myocardial infarction within the past year - No New York Heart Association class II-IV heart disease - No grade II-IV peripheral vascular disease within the past year Ophthalmologic - No significant ophthalmologic abnormalities* including any of the following: - Severe dry eye syndrome - Keratoconjunctivitis sicca - Sjögren's syndrome - Severe exposure keratopathy - Disorders that might increase the risk for epithelium-related complications (e.g., bullous keratopathy, aniridia, severe chemical burns, neutrophilic keratitis) NOTE: *Patients with mild forms of the abnormalities, asymptomatic history, or normal ophthalmologic examination may be eligible at the discretion of the investigator Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No prior allergic reactions to compounds of similar chemical or biologic composition to bevacizumab or other study agents - No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies - No significant traumatic injury within the past 28 days - No other concurrent uncontrolled illness - No psychiatric illness or social situation that would preclude study compliance - No ongoing or active infection requiring parenteral antibiotics - No serious non-healing wound ulcer or bone fracture - No seizures not controlled by standard medical therapy PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) Endocrine therapy - Not specified Radiotherapy - More than 4 weeks since prior radiotherapy Surgery - More than 4 weeks since prior major surgery - More than 4 weeks since prior open biopsy Other - Recovered from prior therapy - No more than 1 prior regimen for recurrent disease - No prior epidermal growth factor receptor (EGFR)-based therapy for recurrent disease - No prior vascular EGFR-based therapy for recurrent disease - No other concurrent investigational agents - No other concurrent anticancer agents or therapies - No concurrent combination antiretroviral therapy for HIV-positive patients - No concurrent chronic use of aspirin (325 mg/day or more) or other nonsteroidal anti-inflammatory drugs - No concurrent warfarin or heparin, including low-molecular weight heparin - No other concurrent or recent (within 1 month) thrombolytic agents or full-dose anticoagulants (except to maintain patency of preexisting, permanent indwelling IV catheters)
Total Enrollment:
Location and Contact Information:
Overall Study Official:
EzraCohen, Principal Investigator, University of Chicago Cancer Research Center
Central Illinois Hematology Oncology Center *Recruiting*
Springfield, Illinois, 62701
United States
Recruiting Edem Agamah 217-525-2500
Cardinal Bernardin Cancer Center at Loyola University Medical Center *Recruiting*
Maywood, Illinois, 60153
United States
Recruiting Ellen Gaynor 708-327-3101
Fort Wayne Medical Oncology and Hematology, Incorporated *Recruiting*
Ft. Wayne, Indiana, 46885-5099
United States
Recruiting David Sciortino 260-484-8830
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph *Recruiting*
Saint Joseph, Michigan, 49085
United States
Recruiting Eric Lester 269-985-0029
University of Illinois Medical Center *Recruiting*
Chicago, Illinois, 60612-7317
United States
Recruiting Fred Rosen 312-996-7975
Ingalls Memorial Hospital *Recruiting*
Harvey, Illinois, 60426
United States
Recruiting Mark Kozloff 708-333-2300
Medical College of Wisconsin Cancer Center *Recruiting*
Milwaukee, Wisconsin, 53226
United States
Recruiting Stuart Wong 414-805-4603
Decatur Memorial Hospital Cancer Care Institute *Recruiting*
Decatur, Illinois, 62526
United States
Recruiting James Wade 217-876-6603
CCOP - Northern Indiana CR Consortium *Recruiting*
South Bend, Indiana, 46601
United States
Recruiting David Taber 574-237-1328
Oncology/Hematology Associates of Central Illinois, P.C. *Recruiting*
Peoria, Illinois, 61602
United States
Recruiting James Knost 309-672-5681
Louis A. Weiss Memorial Hospital *Recruiting*
Chicago, Illinois, 60640
United States
Recruiting Stuart Krauss 773-878-8700
University of Chicago Cancer Research Center *Recruiting*
Chicago, Illinois, 60637-1470
United States
Recruiting Everett Vokes 773-834-3093
Evanston Northwestern Health Care - Evanston Hospital *Recruiting*
Evanston, Illinois, 60201-1781
United States
Recruiting Bruce Brockstein 847-570-1489
LaGrange Memorial Hospital *Recruiting*
LaGrange, Illinois, 60525
United States
Recruiting James Hannigan 708-579-3418
Additional Information:
Study ID Numbers: CDR0000271444; UCCRC-NCI-5701,NCI-5701,UCCRC-11956A
Study Start Date:
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00055913
Other Head And Neck Cancer Studies:
1. Sargramostim in Decreasing Mucositis in Patients Receiving Radiation Therapy for Head and Neck Cancer
2. Erlotinib and Cisplatin in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
3. Celecoxib in Treating Patients With Early-Stage Head and Neck Cancer or Non-Small Cell Lung Cancer
4. Docetaxel and St. John's Wort in Treating Patients With Solid Tumors That Cannot Be Removed By Surgery
5. Perifosine in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
Related Studies:
Other Head and Neck Cancer Clinical Trials
Other Illinois Clinical Trials
Other Chicago Clinical Trials
Bevacizumab and Erlotinib in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
|
|
|
|
|
|
|
|
