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Combination Chemotherapy With or Without Bevacizumab in Treating Patients With
Advanced, Metastatic, or Recurrent Non-Small Cell Lung Cancer

This study is currently recruiting patients.

Sponsored by

Eastern Cooperative Oncology Group

National Cancer Institute (NCI)

Cancer and Leukemia Group B

Purpose

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: Randomized phase II/III trial to study the effectiveness of combination chemotherapy with or without bevacizumab in treating patients who have advanced, metastatic, or recurrent non-small cell lung cancer.

MEDLINEplus related topics:  Cancer (General);   Cancer Alternative Therapy;   Cancer--Living with Cancer;   Lung Cancer;   Respiratory Diseases (General)

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II/III Randomized Study of Paclitaxel and Carboplatin With or Without Bevacizumab in Patients With Advanced, Metastatic, or Recurrent Non-Squamous Cell Non-Small Cell Lung Cancer

Further Study 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, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 640 patients will be accrued for this study within 11-30 months.

Eligibility

Ages Eligible for Study:  18 Years  and above

Genders Eligible for Study:  Both

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

Location and Contact Information

Colorado
      CCOP - Colorado Cancer Research Program, Inc., Denver,  Colorado,  80224,  United States; Recruiting.
      Peter C. Raich, MD 303-777-2663 

Delaware
      CCOP - Christiana Care Health Services, Wilmington,  Delaware,  19899,  United States; Recruiting.
      Stephen Scott Grubbs, MD  302-428-4206 

Florida
      H. Lee Moffitt Cancer Center and Research Institute, Tampa,  Florida,  33612-9497,  United States; Recruiting.
      Cancer Answers 813-972-4673  canceranswers@moffitt.usf.edu 

Georgia
      Emory University Hospital - Atlanta, Atlanta,  Georgia,  30322,  United States; Recruiting.
      William Costin Wood, MD  404-778-2918

      Veterans Affairs Medical Center - Atlanta (Decatur), Decatur,  Georgia,  30033,  United States; Recruiting
      Maria Jose Amarante Ribeiro, MD  404-728-7680  maria.ribeiro@med.va.gov 

Illinois
      CCOP - Central Illinois, Decatur,  Illinois,  62526,  United States; Recruiting.
      James L. Wade, MD 217-876-6618 

      CCOP - Evanston, Evanston,  Illinois,  60201,  United States; Recruiting.
      Gershon Y. Locker, MD, FACP 847-570-2000 

      Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago,  Illinois,  60611,  United States; Recruiting.
      Al Bowen Benson, MD, FACP 312-695-6180 

      Veterans Affairs Medical Center - Lakeside Chicago, Chicago,  Illinois,  60611-4494,  United States; Recruiting.
      Timothy M. Kuzel, MD 312-469-3748 

Indiana
      Indiana University Cancer Center, Indianapolis,  Indiana,  46202-5289,  United States; Recruiting.
      Patrick J. Loehrer, MD  317-278-4822 

      Veterans Affairs Medical Center - Indianapolis (Roudebush), Indianapolis,  Indiana,  46202,  United States; Recruiting.
      Patrick J. Loehrer, MD 317-554-0000 x2861 

Iowa
      Genesis Medical Center, Davenport,  Iowa,  52804,  United States; Recruiting.
      George Kovach, MD  563-421-1908 

      Hematology Oncology Associates of the Quad Cities, Bettendorf,  Iowa,  52722,  United States; Recruiting.
      S. Donald Zaentz, MD, FACP  563-355-7733 

Louisiana
      CCOP - Ochsner, New Orleans,  Louisiana,  70121,  United States; Recruiting.
      Carl G. Kardinal, MD 504-842-3910 

      MBCCOP - LSU Medical Center, New Orleans,  Louisiana,  70112,  United States; Recruiting.
      Jill Gilbert, MD 504-568-5136 

Maryland
      Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore,  Maryland,  21231,  United States; Recruiting.
      Arlene A. Forastiere, MD  410-955-9818  af@jhmi.edu 

Massachusetts
      Beth Israel Deaconess Medical Center, Boston,  Massachusetts,  02215,  United States; Recruiting.
      Daniel David Karp, MD  617-667-1910  dkarp@bidmc.harvard.edu 

Michigan
      CCOP - Ann Arbor Regional, Ann Arbor,  Michigan,  48106,  United States; Recruiting.
      Philip J. Stella, MD  734-712-1000 

      CCOP - Kalamazoo, Kalamazoo,  Michigan,  49007-3731,  United States; Recruiting.
      Raymond Sterling Lord, MD  616-373-7450 

Minnesota
      CCOP - Duluth, Duluth,  Minnesota,  55805,  United States; Recruiting.
      Robert J. Dalton, MD  218-786-8364 

      CCOP - Metro-Minnesota, Saint Louis Park,  Minnesota,  55416,  United States; Recruiting.
      Patrick J. Flynn, MD  952-993-1545 

Missouri
      Ellis Fischel Cancer Center - Columbia, Columbia,  Missouri,  65203,  United States; Recruiting.
      Michael C. Perry, MD  573-882-4979  perrym@health.missouri.edu 

Nebraska
      CCOP - Missouri Valley Cancer Consortium, Omaha,  Nebraska,  68106,  United States; Recruiting.
      James A. Mailliard, MD  402-898-8044 

Nevada
      CCOP - Southern Nevada Cancer Research Foundation, Las Vegas,  Nevada,  89106,  United States; Recruiting.
      John Allan Ellerton, MD, CM  702-384-0013 

New Jersey
      Veterans Affairs Medical Center - East Orange, East Orange,  New Jersey,  07019,  United States; Recruiting.
      Basil S. Kasimis, MD, DSc  973-676-1000 ext. 1544  Basil.Kasimis@med.va.gov 

New York
      James P. Wilmot Cancer Center, Rochester,  New York,  14642,  United States; Recruiting.
      John M. Bennett, MD  716-275-4915  john_bennett@urmc.rochester.edu 

      MBCCOP-Our Lady of Mercy Cancer Center, Bronx,  New York,  10466,  United States; Recruiting.
      Peter H. Wiernik, MD  718-920-1100 

North Dakota
      CCOP - Merit Care Hospital, Fargo,  North Dakota,  58122,  United States; Recruiting.
      Ralph Levitt, MD  701-234-2397 

Ohio
      Ireland Cancer Center, Cleveland,  Ohio,  44106-5065,  United States; Recruiting.
      Edward G. Mansour, MD  216-368-2000 

Oklahoma
      CCOP - Oklahoma, Tulsa,  Oklahoma,  74136,  United States; Recruiting.
      James B. Lockhart, MD  918-491-5878 

Pennsylvania
      CCOP - Geisinger Clinic and Medical Center, Danville,  Pennsylvania,  17822-2001,  United States; Recruiting.
      Suresh G. Nair, MD  570-271-6413 

      Fox Chase Cancer Center, Philadelphia,  Pennsylvania,  19111,  United States; Recruiting.
      Louis M. Weiner, MD  215-728-2480  lm_weiner@fccc.edu 

South Dakota
      CCOP - Sioux Community Cancer Consortium, Sioux Falls,  South Dakota,  57104,  United States; Recruiting.
      Loren K. Tschetter, MD  605-328-8000 

Tennessee
      Vanderbilt-Ingram Cancer Center, Nashville,  Tennessee,  37232-6307,  United States; Recruiting.
      David Horton Johnson, MD  615-343-9454  david.johnson@mcmail.vanderbilt.edu 

      Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus, Nashville,  Tennessee, 
      37212-2637,  United States; Recruiting.
      Kenneth R. Hande, MD  615-327-4751 

Texas
      CCOP - Scott and White Hospital, Temple,  Texas,  76508,  United States; Recruiting.
      Lucas Wong, MD  254-724-1053 

Wisconsin
      CCOP - Marshfield Medical Research and Education Foundation, Marshfield,  Wisconsin,  54449,  United States; Recruiting.
      Tarit Kumar Banerjee, MD, FACP  715-387-5134 

      CCOP - St. Vincent Hospital Cancer Center, Green Bay, Green Bay,  Wisconsin,  54301,  United States; Recruiting.
      Thomas J. Saphner, MD  920-432-5134 

      Medical College of Wisconsin, Milwaukee,  Wisconsin,  53226-3596,  United States; Recruiting.
      David H. Vesole, MD, PhD  414-805-4646  dvesole@bmt.mcw.edu 

      Veterans Affairs Medical Center - Milwaukee (Zablocki), Milwaukee,  Wisconsin,  53295,  United States; Recruiting.
      Mohammed A. Raheem, MD  414-384-2000 

South Africa
      Pretoria Academic Hospitals, Pretoria,  0001,  South Africa; Recruiting.
      Coenraad Frederick Slabber, MD  27-12-354-1054 

Study chairs or principal investigators
     Alan B. Sandler, MD,  Study Chair,  Vanderbilt-Ingram Cancer Center
     Michael C. Perry, MD,  Study Chair,  Ellis Fischel Cancer Center - Columbia

More Information
     Study ID Numbers CDR0000068744;  E-4599; CTSU; CLB-E-4599
     Record last reviewed  December 2002
     NLM Identifier  NCT00021060
     ClinicalTrials.gov processed thisrecord on 2003-05-30

Source: clinicaltrials.gov