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Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Advanced, Metastatic, or Recurrent Non-Small Cell Lung Cancer Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Advanced, Metastatic, or Recurrent Non-Small Cell Lung Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Advanced, Metastatic, or Recurrent Non-Small Cell Lung Cancer Clinical research trials and Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Advanced, Metastatic, or Recurrent Non-Small Cell Lung Cancer medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Advanced, Metastatic, or Recurrent Non-Small Cell Lung Cancer. Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Advanced, Metastatic, or Recurrent Non-Small Cell Lung Cancer Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Advanced, Metastatic, or Recurrent Non-Small Cell Lung Cancer clinical trial. Participants frequently get the best healthcare available for their Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Advanced, Metastatic, or Recurrent Non-Small Cell Lung Cancer condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Advanced, Metastatic, or Recurrent Non-Small Cell Lung Cancer  Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Advanced, Metastatic, or Recurrent Non-Small Cell Lung Cancer
Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Advanced, Metastatic, or Recurrent Non-Small Cell Lung Cancer
For Condition: recurrent non-small cell lung cancer,stage 4 non-small cell lung cancer,stage 3B non-small cell lung cancer
Status: No longer recruiting
Sponsor(s): Eastern Cooperative Oncology Group , National Cancer Institute (NCI),Cancer and Leukemia Group B
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 and monoclonal antibodies may kill more tumor cells. PURPOSE: Randomizedphase II/III trial to study the effectiveness of combination chemotherapy with or without bevacizumab in treating patients who have advanced, metastatic, or recurrentnon-small cell lung cancer.
Details: OBJECTIVES: - Compare the toxicity of paclitaxel and carboplatin with or without bevacizumab in patients with advanced, metastatic, or recurrent non-squamous cell non-small cell lung cancer. - Compare the survival of patients treated with these regimens. - Compare the response rates and time to progression in patients treated with these regimens. OUTLINE: This is a randomized study. Patients are stratified according to measurable disease (yes vs no), prior radiotherapy (yes vs no), weight loss (less than 5% vs 5% or more), and disease stage (IIIB vs IV vs recurrent). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 15-30 minutes on day 1. - Arm II: Patients receive paclitaxel and carboplatin as in arm I followed by bevacizumab IV over 30-90 minutes on day 1. Treatment in both arms repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients in arm II with stable or responding disease continue to receive bevacizumab only. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 842 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) - Stage IIIB with malignant pleural effusion, stage IV, or recurrent - Measurable or nonmeasurable disease - No squamous cell NSCLC - No known CNS metastases by head CT scan or MRI within the past 4 weeks PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-1 Life expectancy: - Not specified Hematopoietic: - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - No prior thrombotic or hemorrhagic disorders Hepatic: - Bilirubin no greater than 1.5 mg/dL - Transaminases no greater than 5 times upper limit of normal (ULN) - PTT normal - INR no greater than 1.5 Renal: - Creatinine no greater than 1.5 times ULN - Urine protein less than 1+ (i.e., trace or 0 by dipstick or urinalysis) OR - 24-hour urine protein less than 500 mg Cardiovascular: - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia - Concurrent hypertension allowed provided well-controlled on a stable regimen of anti-hypertensive therapy Pulmonary: - No history of gross hemoptysis (½ teaspoon of bright red blood or more) Other: - No ongoing or active infection - No serious non-healing wound ulcer - No bone fracture - No psychiatric illness or social situation that would preclude study compliance - No other concurrent comorbidities that would preclude study participation - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 3 weeks since prior immunotherapy and recovered Chemotherapy: - No prior systemic chemotherapy Endocrine therapy: - At least 3 weeks since prior hormonal therapy and recovered Radiotherapy: - At least 3 weeks since prior radiotherapy and recovered Surgery: - At least 3 weeks since prior major surgery Other: - No concurrent therapeutic anticoagulation - No concurrent chronic daily aspirin (greater than 325 mg/day) - No concurrent non-steroidal anti-inflammatory agents known to inhibit platelet function (arm II only) - No concurrent dipyridamole, ticlopidine, clopidogrel, and/or cilostazol
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MichaelPerry, Study Chair, Ellis Fischel Cancer Center at University of Missouri - Columbia
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
Saint Joseph, Michigan, 49085
United States
Veterans Affairs Medical Center - Washington, DC
Washington D.C., District of Columbia, 20422
United States
CCOP - Evanston
Evanston, Illinois, 60201
United States
Fort Wayne Medical Oncology and Hematology, Incorporated
Ft. Wayne, Indiana, 46885-5099
United States
Albert Einstein Clinical Cancer Center
Bronx, New York, 10461
United States
CCOP - Colorado Cancer Research Program, Incorporated
Denver, Colorado, 80224
United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61602
United States
Veterans Affairs Medical Center - Fargo
Fargo, North Dakota, 58102
United States
St. Joseph Hospital
Denver, Colorado, 80218-1191
United States
CCOP - Kalamazoo
Kalamazoo, Michigan, 49007-3731
United States
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, 70112
United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, 54307-3453
United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, 55417-2399
United States
University of Puerto Rico School of Medicine Medical Sciences Campus
San Juan, , 00936-5067
Puerto Rico
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-0001
United States
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, 07019
United States
Medical Center of Aurora - South Campus
Aurora, Colorado, 80012-0000
United States
CCOP - Merit Care Hospital
Fargo, North Dakota, 58122
United States
Longmont United Hospital
Longmont, Colorado, 80501
United States
CCOP - Christiana Care Health Services
Newark, Delaware, 19713
United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, 65203
United States
Broward General Medical Center
Ft. Lauderdale, Florida, 33316
United States
St. Mary's Medical Center
Huntington, West Virginia, 25701
United States
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, 17822-2001
United States
Louis A. Weiss Memorial Hospital
Chicago, Illinois, 60640
United States
CCOP - Central Illinois
Decatur, Illinois, 62526
United States
FirstHealth Moore Regional Hospital
Pinehurst, North Carolina, 28374
United States
CCOP - Ochsner
New Orleans, Louisiana, 70121
United States
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
Nashville, Tennessee, 37232-6307
United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, 57104
United States
Rocky Mountain Cancer Centers
Thornton, Colorado, 80260
United States
Comprehensive Cancer Institute
Huntsville, Alabama, 35801
United States
St. Mary-Corwin Regional Medical Center
Pueblo, Colorado, 81004
United States
Porter Adventist Hospital
Denver, Colorado, 80210
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, 48106
United States
Boulder Community Hospital
Boulder, Colorado, 80301-9019
United States
Oncology and Hematology Associates of Southwest Virginia, Inc.
Roanoke, Virginia, 24014
United States
Virginia Oncology Associates - Norfolk
Norfolk, Virginia, 23502
United States
MetroHealth Medical Center
Cleveland, Ohio, 44109
United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
United States
CCOP - Oklahoma
Tulsa, Oklahoma, 74136
United States
Veterans Affairs Medical Center - Dallas
Dallas, Texas, 75216
United States
Cooper University Hospital
Camden, New Jersey, 08103
United States
Saint Anthony Medical Center
Rockford, Illinois, 61108
United States
MBCCOP - University of New Mexico HSC
Albuquerque, New Mexico, 87131
United States
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, 54449
United States
Veterans Affairs Medical Center - Baltimore
Baltimore, Maryland, 21201
United States
Northeast Alabama Regional Medical Center
Anniston, Alabama, 36207
United States
Cape Fear Valley Health System
Fayetteville, North Carolina, 28302-2000
United States
Memorial Regional Hospital Comprehensive Cancer Center
Hollywood, Florida, 33021
United States
Baptist Hospital East - Louisville
Louisville, Kentucky, 40207
United States
Veterans Affairs Medical Center - Asheville
Asheville, North Carolina, 28805
United States
Presbyterian-St Luke's Medical Center
Denver, Colorado, 80218
United States
Penrose Cancer Center
Colorado Springs, Colorado, 80933
United States
Veterans Affairs Medical Center - Las Vegas
Las Vegas, Nevada, 89106
United States
Lenoir Memorial Hospital Cancer Center
Kinston, North Carolina, 28503-1678
United States
West Suburban Center for Cancer Care
River Forest, Illinois, 60305
United States
Florida Hospital Cancer Institute
Orlando, Florida, 32804
United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309-1016
United States
Veterans Affairs Medical Center - San Diego
San Diego, California, 92161
United States
Queens Cancer Center of Queens Hospital
Jamaica, New York, 11432
United States
Rocky Mountain Cancer Centers - Rose
Denver, Colorado, 80220
United States
Pretoria Academic Hospital
Pretoria, , 0001
South Africa
CCOP - Metro-Minnesota
St. Louis Park, Minnesota, 55416
United States
Palm Beach Cancer Institute
West Palm Beach, Florida, 33401
United States
New Hanover Regional Medical Center
Wilmington, North Carolina, 28402-9025
United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231
United States
NorthEast Oncology Associates
Concord, North Carolina, 28025
United States
Martha Jefferson Hospital
Charlottesville, Virginia, 22902
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111-2497
United States
CCOP - MainLine Health
Wynnewood, Pennsylvania, 19096
United States
Elmhurst Hospital Center
Elmhurst, New York, 11373
United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, 60611
United States
CCOP - Duluth
Duluth, Minnesota, 55805
United States
Ministry Medical Group - Northern Region
Rhinelander, Wisconsin, 54501
United States
Stanford Cancer Center at Stanford University Medical Center
Stanford, California, 94305-5216
United States
CCOP - Scott and White Hospital
Temple, Texas, 76508
United States
Additional Information:
Study ID Numbers: CDR0000068744; CTSU,CALGB-E4599,ECOG-4599
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00021060
Other Recurrent Non-Small Cell Lung Cancer Studies:
1. Docetaxel With or Without Oblimersen in Treating Patients With Non-Small Cell Lung Cancer
2. Docetaxel in Treating Patients With Non-Small Cell Lung Cancer
3. Polyglutamate Paclitaxel Compared With Docetaxel in Treating Patients With Progressive Non-Small Cell Lung Cancer
4. Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer That Can Not Be Surgically Removed
5. Combination Chemotherapy Plus Radiation Therapy With or Without Gefitinib in Treating Patients With Unresectable Stage III Non-Small Cell Lung Cancer
Related Studies:
Other recurrent non-small cell lung cancer Clinical Trials
Other Nevada Clinical Trials
Other Las Vegas Clinical Trials
Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Advanced, Metastatic, or Recurrent Non-Small Cell Lung Cancer
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