Lung Cancer Clinical Trial
Carboplatin, Paclitaxel, and Radiation Therapy With or Without Thalidomide in Patients With Stage III Non-small Cell Lung Cancer
Summary
This randomized phase III trial is studying carboplatin, paclitaxel, radiation therapy, and thalidomide to see how well they work compared to carboplatin, paclitaxel, and radiation therapy alone in treating patients with newly diagnosed stage III non-small cell lung cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the growth of non-small cell lung cancer by stopping blood flow to the tumor. It is not yet known if combination chemotherapy plus radiation therapy is more effective with or without thalidomide.
Full Description
OBJECTIVES:
I. Compare the survival and time to progression of patients with stage IIIA or IIIB non-small cell lung cancer when treated with carboplatin, paclitaxel, and chemoradiotherapy with or without thalidomide.
II. Evaluate the toxicity of the thalidomide-containing regimen and compare response rates of the two groups.
III. Determine whether the inactivation of p16, Death-associated protein kinase (DAP-kinase), O6-methylguanine-DNA methyltransferase (MGMT) gene, or tissue-inhibitor of metalloproteinase 3 (TIMP-3) genes can be used to predict survival in these patients treated with this regimen.
IV. Determine whether the detection of a methylation biomarker in serum can be used to predict survival in these patients treated with this regimen.
OUTLINE: This is a randomized study. Patients are stratified according to disease histology (squamous vs nonsquamous), performance status (0 vs 1), disease stage (IIIA vs IIIB), and time of randomization (before addition of chemoradiotherapy vs after). Patients are randomized to one of two treatment arms.
ARM A: Patients receive paclitaxel intravenously (IV) over 3 hours immediately followed by carboplatin IV over 15-30 minutes on days 1 and 22. Treatment continues every 22 days in the absence of unacceptable toxicity or disease progression.
ARM B: Patients receive paclitaxel and carboplatin as in arm A. Patients also receive oral thalidomide and oral low-dose aspirin daily beginning on day 1 for up to 24 months in the absence of disease progression.
Beginning between days 43-50, patients in both arms with stable or responding disease receive chemoradiotherapy comprising paclitaxel IV over 1 hour and carboplatin IV over 15-30 minutes once weekly for 6 weeks and radiotherapy (RT) 5 days a week for 6 weeks. Arm B patients continue oral thalidomide.
Patients are followed every 2 months for 2 years and then every 6 months for 3 years.
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed newly diagnosed non-small cell bronchogenic carcinoma
Squamous cell
Adenocarcinoma
Large cell undifferentiated
Bronchoalveolar
Non-small cell carcinoma not otherwise stated
Unresectable stage IIIA
Mediastinal lymph node enlargement of at least 1 cm but less than 2 cm on computed tomography (CT) scans must have mediastinotomy or thoracoscopy to rule out resectability
OR
Stage IIIB disease without significant pleural effusion
Seen on CT scan only (not seen on chest x-ray) or does not reaccumulate after 1 thoracentesis and is cytologically negative
Metastases to contralateral, mediastinal, or supraclavicular nodes allowed
Bidimensionally measurable or evaluable disease
18 and over
ECOG performance status 0-1
Adequate hematopoietic, hepatic, and renal function obtained <=4 weeks prior to registration:
Platelet count at least 100,000/mm^3
White Blood Cell (WBC) count at least 4,000/mm^3 OR absolute neutrophil count at least 2,000/mm^3
Bilirubin normal
Serum glutamic oxaloacetic transaminase (SGOT) no greater than 2.5 times upper limit of normal
Creatinine no greater than 1.5 mg/dL OR creatinine clearance at least 60 mL/min
Fertile patients must use 2 methods of effective contraception for 4 weeks prior to, during, and for 4 weeks after study therapy
Concurrent filgrastim (G-CSF) allowed for persistent neutropenia
Exclusion Criteria:
Positive pregnancy test,pregnant or nursing
Uncontrolled high blood pressure, unstable angina, congestive heart failure, or myocardial infarction within the prior year
Serious cardiac arrhythmias requiring medication
Prior radiotherapy to only area of measurable or active tumor
Less than 5 years since prior chemotherapy
Other active malignancies
Serious uncontrolled active infection
Evidence of greater than grade 1 neuropathy by history or physical examination
History of seizure disorders
Contraindication to daily low-dose (81 mg/day) aspirin
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There are 210 Locations for this study
Ft. Smith Arkansas, 72903, United States
Modesto California, 95355, United States
Salinas California, 93901, United States
Stanford California, 94305, United States
Aurora Colorado, 80012, United States
Boulder Colorado, 80301, United States
Colorado Springs Colorado, 80909, United States
Colorado Springs Colorado, 80933, United States
Denver Colorado, 80210, United States
Denver Colorado, 80218, United States
Denver Colorado, 80218, United States
Denver Colorado, 80220, United States
Denver Colorado, 80224, United States
Englewood Colorado, 80110, United States
Grand Junction Colorado, 81502, United States
Lone Tree Colorado, 80124, United States
Longmont Colorado, 80502, United States
Pueblo Colorado, 81004, United States
Thornton Colorado, 80229, United States
Danbury Connecticut, 06810, United States
Norwich Connecticut, 06360, United States
Daytona Beach Florida, 32115, United States
Jacksonville Florida, 32207, United States
Augusta Georgia, 30904, United States
Augusta Georgia, 30912, United States
Decatur Georgia, 30033, United States
Macon Georgia, 31208, United States
Savannah Georgia, 31403, United States
Valdosta Georgia, 31603, United States
Chicago Illinois, 60611, United States
Chicago Illinois, 60616, United States
Chicago Illinois, 60625, United States
Hinsdale Illinois, 60521, United States
Joliet Illinois, 60432, United States
Moline Illinois, 61265, United States
Rockford Illinois, 61104, United States
Skokie Illinois, 60076, United States
Elkhart Indiana, 46515, United States
Kokomo Indiana, 46904, United States
La Porte Indiana, 46350, United States
Richmond Indiana, 47374, United States
South Bend Indiana, 46601, United States
South Bend Indiana, 46601, United States
South Bend Indiana, 46617, United States
Bettendorf Iowa, 52722, United States
Cedar Rapids Iowa, 52402, United States
Cedar Rapids Iowa, 52403, United States
Cedar Rapids Iowa, 52403, United States
Davenport Iowa, 52803, United States
Des Moines Iowa, 50307, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50314, United States
Des Moines Iowa, 50314, United States
Des Moines Iowa, 50316, United States
Sioux City Iowa, 51101, United States
Sioux City Iowa, 51104, United States
Sioux City Iowa, 51104, United States
West Des Moines Iowa, 50266, United States
Madisonville Kentucky, 42431, United States
Annapolis Maryland, 21401, United States
Boston Massachusetts, 02111, United States
Newton Massachusetts, 02462, United States
Springfield Massachusetts, 01199, United States
Taunton Massachusetts, 02780, United States
Adrian Michigan, 49221, United States
Ann Arbor Michigan, 48106, United States
Ann Arbor Michigan, 48106, United States
Dearborn Michigan, 48123, United States
Escanaba Michigan, 49431, United States
Flint Michigan, 48503, United States
Flint Michigan, 48503, United States
Grosse Pointe Woods Michigan, 48236, United States
Iron Mountain Michigan, 49801, United States
Jackson Michigan, 49201, United States
Kalamazooaa Michigan, 49001, United States
Kalamazoo Michigan, 49007, United States
Kalamazoo Michigan, 49007, United States
Lambertville Michigan, 48144, United States
Lansing Michigan, 48909, United States
Monroe Michigan, 48162, United States
Saginaw Michigan, 48601, United States
St. Joseph Michigan, 49085, United States
Warren Michigan, 48093, United States
Burnsville Minnesota, 55337, United States
Coon Rapids Minnesota, 55433, United States
Duluth Minnesota, 55805, United States
Duluth Minnesota, 55805, United States
Duluth Minnesota, 55805, United States
Edina Minnesota, 55435, United States
Fergus Falls Minnesota, 56537, United States
Fridley Minnesota, 55432, United States
Hutchinson Minnesota, 55350, United States
Lichfield Minnesota, 55355, United States
Maplewood Minnesota, 55109, United States
Minneapolis Minnesota, 55407, United States
Minneapolis Minnesota, 55415, United States
Robbinsdale Minnesota, 55422, United States
Saint Louis Park Minnesota, 55416, United States
Shakopee Minnesota, 55379, United States
St Paul Minnesota, 55102, United States
St. Cloud Minnesota, 56303, United States
St. Louis Park Minnesota, 55416, United States
St. Paul Minnesota, 55101, United States
St. Paul Minnesota, 55102, United States
Waconia Minnesota, 55387, United States
Woodbury Minnesota, 55125, United States
Kansas City Missouri, 64131, United States
Springfield Missouri, 65804, United States
Springfield Missouri, 65807, United States
St. Louis Missouri, 63131, United States
Billings Montana, 59101, United States
Billings Montana, 59101, United States
Billings Montana, 59107, United States
Great Falls Montana, 59405, United States
Great Falls Montana, 59405, United States
Great Falls Montana, 59405, United States
Great Falls Montana, 59405, United States
Lincoln Nebraska, 68510, United States
Omaha Nebraska, 68106, United States
Omaha Nebraska, 68122, United States
Omaha Nebraska, 68124, United States
Omaha Nebraska, 68131, United States
Las Vegas Nevada, 89106, United States
East Orange New Jersey, 07018, United States
Flemington New Jersey, 08822, United States
Hamilton New Jersey, 08690, United States
Marlton New Jersey, 08053, United States
Montclair New Jersey, 07042, United States
Morristown New Jersey, 07962, United States
New Brunswick New Jersey, 08903, United States
Phillipsburg New Jersey, 08865, United States
Red Bank New Jersey, 07701, United States
Somers Point New Jersey, 08244, United States
Summit New Jersey, 07902, United States
Voorhees New Jersey, 08043, United States
Bronx New York, 10461, United States
Bronx New York, 10466, United States
Buffalo New York, 14215, United States
Rochester New York, 14621, United States
Syracuse New York, 13057, United States
Goldsboro North Carolina, 27534, United States
Wilson North Carolina, 27893, United States
Bismarck North Dakota, 58501, United States
Bismarck North Dakota, 58501, United States
Bismarck North Dakota, 58501, United States
Bismarck North Dakota, 58502, United States
Akron Ohio, 44309, United States
Canton Ohio, 44710, United States
Chillicothe Ohio, 45601, United States
Cleveland Ohio, 44109, United States
Columbus Ohio, 43214, United States
Columbus Ohio, 43215, United States
Columbus Ohio, 43215, United States
Columbus Ohio, 43222, United States
Columbus Ohio, 43228, United States
Dayton Ohio, 45409, United States
Dayton Ohio, 45415, United States
Dayton Ohio, 45428, United States
Delaware Ohio, 43015, United States
Findlay Ohio, 45840, United States
Fremont Ohio, 43420, United States
Kettering Ohio, 45429, United States
Lancaster Ohio, 43130, United States
Lima Ohio, 45801, United States
Lima Ohio, 45804, United States
Mansfield Ohio, 44903, United States
Marietta Ohio, 45750, United States
Maumee Ohio, 43537, United States
Maumee Ohio, 43623, United States
Newark Ohio, 43055, United States
Oregon Ohio, 43616, United States
Sandusky Ohio, 44870, United States
Springfield Ohio, 45504, United States
Springfield Ohio, 45505, United States
Sylvania Ohio, 43560, United States
Tiffin Ohio, 44883, United States
Toledo Ohio, 43606, United States
Toledo Ohio, 43608, United States
Toledo Ohio, 43614, United States
Toledo Ohio, 43623, United States
Toledo Ohio, 43623, United States
Troy Ohio, 45373, United States
Wauseon Ohio, 43567, United States
Allentown Pennsylvania, 18105, United States
Bryn Mawr Pennsylvania, 19010, United States
Danville Pennsylvania, 17822, United States
Dubois Pennsylvania, 15801, United States
Easton Pennsylvania, 18042, United States
Harrisburg Pennsylvania, 17105, United States
Hershey Pennsylvania, 17033, United States
Lancaster Pennsylvania, 17604, United States
Lewistown Pennsylvania, 17044, United States
Paoli Pennsylvania, 19301, United States
Philadelphia Pennsylvania, 19107, United States
Phoenixville Pennsylvania, 19460, United States
Pittsburgh Pennsylvania, 15212, United States
Pittsburgh Pennsylvania, 15232, United States
Pottstown Pennsylvania, 19464, United States
Reading Pennsylvania, 19612, United States
Scranton Pennsylvania, 18501, United States
Scranton Pennsylvania, 18510, United States
Sellersville Pennsylvania, 18960, United States
State College Pennsylvania, 16803, United States
West Grove Pennsylvania, 19390, United States
Wilkes-Barre Pennsylvania, 18711, United States
Wynnewood Pennsylvania, 19096, United States
Wynnewood Pennsylvania, 19096, United States
Aiken South Carolina, 29801, United States
Greenville South Carolina, 29615, United States
Sioux Falls South Dakota, 57105, United States
Sioux Falls South Dakota, 57105, United States
Sioux Falls South Dakota, 57117, United States
Kingsport Tennessee, 37662, United States
Nashville Tennessee, 37208, United States
Temple Texas, 76508, United States
Charlottesville Virginia, 22908, United States
Danville Virginia, 24541, United States
Norton Virginia, 24273, United States
Richmond Virginia, 23298, United States
Charleston West Virginia, 25304, United States
Huntington West Virginia, 25701, United States
Green Bay Wisconsin, 54301, United States
Green Bay Wisconsin, 54303, United States
Green Bay Wisconsin, 54303, United States
Green Bay Wisconsin, 54307, United States
La Crosse Wisconsin, 54601, United States
Madison Wisconsin, 53717, United States
Madison Wisconsin, 53792, United States
Marinette Wisconsin, 54143, United States
Marshfield Wisconsin, 54449, United States
Oconto Falls Wisconsin, 54154, United States
Racine Wisconsin, 53405, United States
Sturgeon Bay Wisconsin, 54235, United States
Pretoria , 0001, South Africa
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