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Bevacizumab and Gemcitabine in Treating Patients With Advanced Pancreatic Cancer Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about Bevacizumab and Gemcitabine in Treating Patients With Advanced Pancreatic Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Bevacizumab and Gemcitabine in Treating Patients With Advanced Pancreatic Cancer Clinical research trials and Bevacizumab and Gemcitabine in Treating Patients With Advanced Pancreatic Cancer health trials occur in a lot of of places throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as Bevacizumab and Gemcitabine in Treating Patients With Advanced Pancreatic Cancer. Bevacizumab and Gemcitabine in Treating Patients With Advanced Pancreatic Cancer Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a Bevacizumab and Gemcitabine in Treating Patients With Advanced Pancreatic Cancer clinical trial. Human subjects frequently get the finest healthcare available for their Bevacizumab and Gemcitabine in Treating Patients With Advanced Pancreatic Cancer condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
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Home > "B" Clinical Trials Conditions > Bevacizumab and Gemcitabine in Treating Patients With Advanced Pancreatic Cancer  Bevacizumab and Gemcitabine in Treating Patients With Advanced Pancreatic Cancer
Bevacizumab and Gemcitabine in Treating Patients With Advanced Pancreatic Cancer
For Condition: stage 4B pancreatic cancer,adenocarcinoma of the pancreas,stage 4A pancreatic cancer,stage 3 pancreatic cancer,recurrent pancreatic cancer
Status: Recruiting
Sponsor(s): University of Chicago Cancer Research Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. 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 chemotherapy with monoclonal antibodies may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine with bevacizumab in treating patients who have advanced pancreatic cancer.
Details: OBJECTIVES: - Determine the objective response rate of patients with advanced pancreatic cancer treated with bevacizumab and gemcitabine. - Determine the toxicity of this regimen in these patients. - Determine the median and overall survival of patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 21-50 patients will be accrued for this study within 8-10 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed pancreatic adenocarcinoma - Not amenable to curative treatment with surgery or radiotherapy - Locally advanced disease must extend outside the boundaries of a standard radiation port - At least 1 unidimensionally measurable lesion - At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan - Pleural effusions and ascites not considered measurable lesions - 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 Life expectancy: - More than 3 months 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 prior bleeding diathesis Hepatic: - Bilirubin normal - AST/ALT no greater than 2.5 times upper limit of normal - PT INR no greater than 1.5 Renal: - Creatinine no greater than 1.5 mg/dL OR - Creatinine clearance at least 60 mL/min - Urine protein less than 500 mg/24 hours if at least 1+ proteinuria - No significant renal impairment Cardiovascular: - No prior cardiovascular accident - No prior deep vein thrombosis - No myocardial ischemia or infarction within the past 6 months - No uncompensated coronary artery disease within the past 6 months - No uncontrolled hypertension - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Pulmonary: - No prior pulmonary embolism Other: - No concurrent uncontrolled illness - No ongoing or active infection - No other concurrent active malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix - No psychiatric illness or social situation that would preclude study entry - No prior allergic reaction attributed to compounds of similar chemical or biologic composition to bevacizumab or other agents (Chinese hamster ovary cell products or other recombinant human antibodies) used in this study - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior bevacizumab Chemotherapy: - No prior cytotoxic chemotherapy for metastatic disease - No prior gemcitabine - At least 4 weeks since prior adjuvant chemotherapy and recovered Endocrine therapy: - Not specified Radiotherapy: - See Disease Characteristics - At least 4 weeks since prior radiotherapy and recovered - No prior radiotherapy to sole site of measurable disease Surgery: - See Disease Characteristics - At least 6 weeks since prior major surgery Other: - At least 30 days since prior investigational agents - At least 1 month since prior and no concurrent thrombolytic agents or full-dose anticoagulants (except to maintain patency of pre-existing permanent indwelling IV catheters) - No concurrent chronic daily aspirin (more than 325 mg/day) or nonsteroidal anti-inflammatory drugs known to inhibit platelet function - No other concurrent investigational agents - No concurrent combination antiretroviral therapy for HIV-positive patients - No other concurrent anticancer therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HedyKindler, Study Chair, University of Chicago Cancer Research Center
University of Chicago Cancer Research Center *Recruiting*
Chicago, Illinois, 60637-1470
United States
Recruiting Hedy Kindler 773-702-0360
Decatur Memorial Hospital Cancer Care Institute *Recruiting*
Decatur, Illinois, 62526
United States
Recruiting James Wade 217-876-6603
Howard University Cancer Center *Recruiting*
Washington D.C., District of Columbia, 20060
United States
Recruiting Fitzroy Dawkins 202-865-6625
Ingalls Memorial Hospital *Recruiting*
Harvey, Illinois, 60426
United States
Recruiting Mark Kozloff 708-339-4800
Fort Wayne Medical Oncology and Hematology, Incorporated *Recruiting*
Ft. Wayne, Indiana, 46885-5099
United States
Recruiting David Sciortino 260-484-8830
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins *Recruiting*
Baltimore, Maryland, 21231
United States
Recruiting Manuel Hidalgo 410-502-7149
Hillman Cancer Center at University of Pittsburgh Cancer Institute *Recruiting*
Pittsburgh, Pennsylvania, 15232
United States
Recruiting Ramesh Ramanathan 412-648-6507
Barbara Ann Karmanos Cancer Institute *Recruiting*
Detroit, Michigan, 48201
United States
Recruiting Patricia LoRusso 313-993-0559
Mayo Clinic *Recruiting*
Jacksonville, Florida, 32224
United States
Recruiting William Maples 904-953-7292
Siteman Cancer Center *Recruiting*
St. Louis, Missouri, 63110
United States
Recruiting Paula Fracasso 314-454-5218
Memorial Hospital of South Bend *Recruiting*
South Bend, Indiana, 46617
United States
Recruiting David Taber 219-237-1328
CCOP - Northern Indiana CR Consortium *Recruiting*
South Bend, Indiana, 46601
United States
Recruiting David Taber 574-237-1328
City of Hope Comprehensive Cancer Center *Recruiting*
Duarte, California, 91010-3000
United States
Recruiting Stephen Shibata 916-734-3772
Mayo Clinic Scottsdale *Recruiting*
Scottsdale, Arizona, 85259
United States
Recruiting Tom Fitch 480-301-9875
City of Hope Medical Group *Recruiting*
Pasadena, California, 91105
United States
Recruiting Mark McNamara 626-396-2900
Oncology/Hematology Associates of Central Illinois, P.C. *Recruiting*
Peoria, Illinois, 61602
United States
Recruiting James Knost 309-672-5681
Medical College of Wisconsin Cancer Center *Recruiting*
Milwaukee, Wisconsin, 53226
United States
Recruiting Stuart Wong 414-805-4603
University of Wisconsin Comprehensive Cancer Center *Recruiting*
Madison, Wisconsin, 53792-3236
United States
Recruiting Kyle Holen 608-265-6222
USC/Norris Comprehensive Cancer Center and Hospital *Recruiting*
Los Angeles, California, 90033
United States
Recruiting Heinz-Josef Lenz 323-865-3955
Mayo Clinic Cancer Center *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting Henry Pitot 507-284-2511
LaGrange Memorial Hospital *Recruiting*
LaGrange, Illinois, 60525
United States
Recruiting James Hannigan 708-579-3418
University of California Davis Cancer Center *Recruiting*
Sacramento, California, 95817
United States
Recruiting David Gandara 916-734-3772
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph *Recruiting*
Saint Joseph, Michigan, 49085
United States
Recruiting Eric Lester 269-985-0029
Evanston Northwestern Health Care - Evanston Hospital *Recruiting*
Evanston, Illinois, 60201-1781
United States
Recruiting Bruce Brockstein 847-570-2515
Additional Information:
Study ID Numbers: CDR0000069138; UCCRC-11255B,NCI-2675,UCCRC-NCI-2675
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00028834
Other Stage 4b Pancreatic Cancer Studies:
1. UCN-01 and Fluorouracil in Treating Patients With Metastatic Pancreatic Cancer
2. CCI-779 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
3. Nitrocamptothecin or Fluorouracil in Treating Patients With Recurrent or Refractory Pancreatic Cancer
4. Glufosfamide With or Without Hydration in Treating Patients With Advanced Pancreatic Cancer
5. Gemcitabine Plus Oxaliplatin in Treating Patients With Refractory Locally Advanced or Metastatic Pancreatic Cancer
Related Studies:
Other stage 4B pancreatic cancer Clinical Trials
Other Wisconsin Clinical Trials
Other Madison Clinical Trials
Bevacizumab and Gemcitabine in Treating Patients With Advanced Pancreatic Cancer
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