Randomized Phase III Study of Maintenance Therapy With Bevacizumab, Pemetrexed, or a Combination of Bevacizumab and Pemetrexed Following Carboplatin, Paclitaxel and Bevacizumab for Advanced Non-Squamous NSCLC
Randomized Phase III Study of Maintenance Therapy With Bevacizumab, Pemetrexed, or a Combination of Bevacizumab and Pemetrexed Following Carboplatin, Paclitaxel and Bevacizumab for Advanced Non-Squamous NSCLC
RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of non-small cell lung cancer by blocking blood flow to the tumor. Pemetrexed disodium may stop the growth of tumor cells by blocking some enzymes needed for cell growth. It is not yet known whether giving bevacizumab or pemetrexed disodium alone or in combination is more effective in treating non-squamous non-small cell lung cancer.
PURPOSE: This randomized phase III trial is studying bevacizumab and pemetrexed disodium alone or in combination after induction therapy to see how well they work in treating patients with advanced non-squamous non-small cell lung cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to gender (male vs female), stage of disease (IIIB-T4Nx [with nodule in ipsilateral lung lobe and not candidate for combined chemotherapy and radiation] and IV M1a vs IV M1b vs recurrent), best response to first-time therapy (complete response/partial response vs stable disease), and smoking status (never vs smoker).
Induction therapy (Arm I): Patients receive paclitaxel IV over 3 hours, carboplatin IV over 15-30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Maintenance Therapy: Patients achieving complete response, partial response or stable disease following induction therapy are randomized to 1 of 3 treatment arms. Treatment begins within 6 weeks of the last day of induction chemotherapy administration.
Some patients undergo blood sample collection at baseline and periodically during study for correlative studies.
After completion of study therapy, patients are followed up every 3 months for 2 years and then every 6 months for 2-5 years.
Inclusion Criteria (Step 1 Induction Therapy):
Exclusion Criteria (Step 1 Induction Therapy):
Inclusion Criteria (Step 2 Maintenance Therapy):
Fairbanks, Alaska 99701, United States
Long Beach, California 90806, United States
Monterey, California 93940, United States
Hartford, Connecticut 06102-5037, United States
Hartford, Connecticut 06105, United States
New Britain, Connecticut 06050, United States
Washington D.C., District of Columbia 20002, United States
Washington D.C., District of Columbia 20422, United States
Fort Lauderdale, Florida 33308, United States
Orlando, Florida 32803-1273, United States
Savannah, Georgia 31405, United States
Valdosta, Georgia 31602, United States
Boise, Idaho 83706, United States
Boise, Idaho 83712, United States
Chicago, Illinois 60611-3013, United States
Libertyville, Illinois 60048, United States
Beech Grove, Indiana 46107, United States
Des Moines, Iowa 50309, United States
Des Moines, Iowa 50314, United States
Owensboro, Kentucky 42303, United States
Shreveport, Louisiana 71130-3932, United States
Cumberland, Maryland 21502, United States
Largo, Maryland 20774, United States
Springfield, Massachusetts 01199, United States
Dearborn, Michigan 48123-2500, United States
Grosse Pointe Woods, Michigan 48236, United States
Minneapolis, Minnesota 55407, United States
Robbinsdale, Minnesota 55422-2900, United States
Billings, Montana 59102, United States
Missoula, Montana 59807, United States
Marlton, New Jersey 08053, United States
Morristown, New Jersey 07960, United States
Vineland, New Jersey 08360, United States
Voorhees Township, New Jersey 08043, United States
Cooperstown, New York 13326, United States
Staten Island, New York 10305, United States
The Bronx, New York 10461, United States
White Plains, New York 10601, United States
Chapel Hill, North Carolina 27599-7295, United States
Charlotte, North Carolina 28233-3549, United States
Greensboro, North Carolina 27403-1198, United States
Wright-Patterson Air Force Base, Ohio 45433-5529, United States
Allentown, Pennsylvania 18105, United States
Harrisburg, Pennsylvania 17110-2098, United States
Hershey, Pennsylvania 17033-0850, United States
Philadelphia, Pennsylvania 19107-5541, United States
Philadelphia, Pennsylvania 19143, United States
Reading, Pennsylvania 19612-6052, United States
Scranton, Pennsylvania 18510, United States
Wilkes-Barre, Pennsylvania 18711, United States
Williamsport, Pennsylvania 17701, United States
Spartanburg, South Carolina 29303, United States
Sioux Falls, South Dakota 57117-5039, United States
Jackson, Tennessee 38301, United States
Kingsport, Tennessee 37662, United States
Charleston, West Virginia 25304, United States
Morgantown, West Virginia 26506, United States
Green Bay, Wisconsin 54301-3526, United States
Green Bay, Wisconsin 54311, United States
Manitowoc, Wisconsin 54221-1450, United States
Summit, Wisconsin 53066, United States
Wausau, Wisconsin 54401, United States