Docetaxel With or Without Infliximab in Treating Weight Loss, Loss of Appetite, and Fatigue in Patients With Unresectable Non-Small Cell Lung Cancer (Infliximab Treatment Discontinued Effective 10/05/05)
5. december 2016 opdateret af: Alliance for Clinical Trials in Oncology
Docetaxel And Infliximab/Placebo In Non-Small Cell Lung Cancer (NSCLC) Patients Greater Than Or Equal To 65 Years Of Age Or In NSCLC Patients With Poor Performance Status: A Double-Blind Randomized, Placebo-Controlled Trial To Prevent And Treat Wasting, Anorexia, And Asthenia In Chemotherapy-Naive And Previously-Treated Patients
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Infliximab may improve cancer-related weight loss, lack of appetite, and fatigue. It is not yet known whether docetaxel is more effective with or without infliximab in preventing weight loss and fatigue in patients with advanced cancer. (Infliximab treatment discontinued effective 10/05/05)
PURPOSE: Randomized phase III trial to determine the effectiveness of docetaxel with or without infliximab in preventing weight loss, loss of appetite, and fatigue in patients who have unresectable non-small cell lung cancer. (Infliximab treatment discontinued effective 10/05/05)
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
OBJECTIVES:
- Compare the improvement or stabilization of weight in elderly or poor performance status patients with unresectable non-small cell lung cancer treated with docetaxel with or without infliximab (infliximab treatment discontinued effective 10/05/05).
- Compare appetite and functional status in patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
- Compare the augmentation or maintenance of lean tissue in patients treated with these regimens.
- Compare the response rates and time to disease progression in patients treated with these regimens.
- Compare the survival of patients treated with these regimens.
- Determine whether the tumor necrosis factor-alpha polymorphisms in the -308 and -238 regions predict which cancer patients will experience loss of appetite and weight and which patients might potentially benefit from infliximab (infliximab treatment discontinued effective 10/05/05).
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to weight loss within the past 6 months (0% vs more than 0% to less than 5% vs at least 5%), number of prior chemotherapy regimens (0 vs 1 vs more than 1), gender, and GBU prognostic index (good vs bad vs unsure).
- Part A (non-randomized, single-center portion of study): Five patients receive infliximab IV (infliximab treatment discontinued effective 10/05/05) over 2 hours once weekly on weeks 1, 3, and 5 of the first course and once weekly on weeks 1 and 5 of all subsequent courses and docetaxel IV over 1 hour (immediately after completion of infliximab infusion [infliximab treatment discontinued effective 10/05/05]) once weekly on weeks 1-6 of each course. Treatment repeats every 8 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity.
If none of the 5 patients experiences any grade 4 or 5 toxicity directly attributable to infliximab (infliximab treatment discontinued effective 10/05/05), additional patients are accrued for part B of the study.
Part B (randomized, multicenter portion of study): Patients are randomized to 1 of 2 treatment arms.
- Arm I (infliximab treatment discontinued effective 10/05/05): Patients receive infliximab and docetaxel as in part A.
- Arm II: Patients receive docetaxel as in part A and placebo IV over 2 hours according to the infliximab schedule in part A (infliximab treatment discontinued effective 10/05/05).
Treatment in both arms repeats as in part A.
Quality of life, fatigue, appetite/anorexia, cachexia, and weight are assessed at baseline, weekly on weeks 1-8, and then monthly for the remainder of study treatment.
Patients are followed every 6 months for 5 years.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
67
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Arizona
-
Scottsdale, Arizona, Forenede Stater, 85259
- CCOP - Mayo Clinic Scottsdale Oncology Program
-
-
Colorado
-
Aurora, Colorado, Forenede Stater, 80012
- Aurora Presbyterian Hospital
-
Boulder, Colorado, Forenede Stater, 80301
- Boulder Community Hospital
-
Colorado Springs, Colorado, Forenede Stater, 80933
- Penrose Cancer Center at Penrose Hospital
-
Denver, Colorado, Forenede Stater, 80210
- Porter Adventist Hospital
-
Denver, Colorado, Forenede Stater, 80220
- Rose Medical Center
-
Denver, Colorado, Forenede Stater, 80218
- Presbyterian - St. Luke's Medical Center
-
Denver, Colorado, Forenede Stater, 80218
- St. Joseph Hospital
-
Denver, Colorado, Forenede Stater, 80224-2522
- CCOP - Colorado Cancer Research Program, Incorporated
-
Englewood, Colorado, Forenede Stater, 80110
- Swedish Medical Center
-
Lone Tree, Colorado, Forenede Stater, 80124
- Sky Ridge Medical Center
-
Longmont, Colorado, Forenede Stater, 80502
- Hope Cancer Care Center at Longmont United Hospital
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Pueblo, Colorado, Forenede Stater, 81004
- St. Mary-Corwin Regional Medical Center
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Thorton, Colorado, Forenede Stater, 80229
- North Suburban Medical Center
-
-
Florida
-
Jacksonville, Florida, Forenede Stater, 32224-9980
- Mayo Clinic - Jacksonville
-
-
Illinois
-
Aurora, Illinois, Forenede Stater, 60507
- Rush-Copley Cancer Care Center
-
Bloomington, Illinois, Forenede Stater, 61701
- St. Joseph Medical Center
-
Canton, Illinois, Forenede Stater, 61520
- Graham Hospital
-
Carthage, Illinois, Forenede Stater, 62321
- Memorial Hospital
-
Eureka, Illinois, Forenede Stater, 61530
- Eureka Community Hospital
-
Galesburg, Illinois, Forenede Stater, 61401
- Galesburg Cottage Hospital
-
Galesburg, Illinois, Forenede Stater, 61401
- Galesburg Clinic
-
Galesburg, Illinois, Forenede Stater, 61401
- InterCommunity Cancer Center of Western Illinois
-
Havana, Illinois, Forenede Stater, 62644
- Mason District Hospital
-
Hopedale, Illinois, Forenede Stater, 61747
- Hopedale Medical Complex
-
Joliet, Illinois, Forenede Stater, 60435
- Joliet Oncology Hematology Associates, Limited - West
-
Kewanee, Illinois, Forenede Stater, 61443
- Kewanee Hospital
-
Macomb, Illinois, Forenede Stater, 61455
- Mcdonough District Hospital
-
Normal, Illinois, Forenede Stater, 61761
- Bromenn Regional Medical Center
-
Normal, Illinois, Forenede Stater, 61761
- Community Cancer Center
-
Ottawa, Illinois, Forenede Stater, 61350
- Community Hospital of Ottawa
-
Ottawa, Illinois, Forenede Stater, 61350
- Oncology Hematology Associates of Central Illinois - Ottawa
-
Pekin, Illinois, Forenede Stater, 61554
- Cancer Treatment Center at Pekin Hospital
-
Peoria, Illinois, Forenede Stater, 61614
- Proctor Hospital
-
Peoria, Illinois, Forenede Stater, 61603
- Methodist Medical Center of Illinois
-
Peoria, Illinois, Forenede Stater, 61637
- OSF St. Francis Medical Center
-
Peoria, Illinois, Forenede Stater, 61615
- CCOP - Illinois Oncology Research Association
-
Peoria, Illinois, Forenede Stater, 61615
- Oncology/Hematology Associates of Central Illinois, P.C.
-
Peru, Illinois, Forenede Stater, 61354
- Illinois Valley Community Hospital
-
Princeton, Illinois, Forenede Stater, 61356
- Perry Memorial Hospital
-
Spring Valley, Illinois, Forenede Stater, 61362
- St. Margaret's Hospital
-
Spring Valley, Illinois, Forenede Stater, 61362
- Valley Cancer Center
-
Urbana, Illinois, Forenede Stater, 61801
- Carle Cancer Center at Carle Foundation Hospital
-
Urbana, Illinois, Forenede Stater, 61801
- CCOP - Carle Cancer Center
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Indiana
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Beech Grove, Indiana, Forenede Stater, 46107
- St. Francis Hospital and Health Centers
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Michigan City, Indiana, Forenede Stater, 46360
- Saint Anthony Memorial Health Centers
-
-
Iowa
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Carroll, Iowa, Forenede Stater, 51401
- Saint Anthony Regional Hospital
-
Cedar Rapids, Iowa, Forenede Stater, 52402
- St. Luke's Hospital
-
Cedar Rapids, Iowa, Forenede Stater, 52403
- Cedar Rapids Oncology Associates
-
Cedar Rapids, Iowa, Forenede Stater, 52403
- Mercy Cancer Center at Mercy Medical Center
-
Council Bluffs, Iowa, Forenede Stater, 51503
- Alegent Health Mercy Hospital
-
Des Moines, Iowa, Forenede Stater, 50309
- CCOP - Iowa Oncology Research Association
-
Des Moines, Iowa, Forenede Stater, 50309
- John Stoddard Cancer Center at Iowa Methodist Medical Center
-
Des Moines, Iowa, Forenede Stater, 50309
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
-
Des Moines, Iowa, Forenede Stater, 50314
- Medical Oncology and Hematology Associates at Mercy Cancer Center
-
Des Moines, Iowa, Forenede Stater, 50314
- Mercy Cancer Center at Mercy Medical Center - Des Moines
-
Des Moines, Iowa, Forenede Stater, 50316
- John Stoddard Cancer Center at Iowa Lutheran Hospital
-
Des Moines, Iowa, Forenede Stater, 50307
- Mercy Capitol Hospital
-
Mason City, Iowa, Forenede Stater, 50401
- Mercy Cancer Center at Mercy Medical Center - North Iowa
-
Missouri Valley, Iowa, Forenede Stater, 51555
- Alegent Health Community Memorial Hospital
-
Onawa, Iowa, Forenede Stater, 51040
- Burgess Health Center
-
Ottumwa, Iowa, Forenede Stater, 52501
- Ottumwa Regional Health Center Cancer Center
-
Sioux City, Iowa, Forenede Stater, 51101-1733
- Siouxland Regional Cancer Center
-
Sioux City, Iowa, Forenede Stater, 51104
- St. Luke's Regional Medical Center
-
Sioux City, Iowa, Forenede Stater, 51104
- Mercy Medical Center - Sioux City
-
Sioux City, Iowa, Forenede Stater, 51101
- Siouxland Hematology-Oncology Associates
-
West Des Moines, Iowa, Forenede Stater, 50266
- Medical Oncology and Hematology Associates - West Des Moines
-
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Kansas
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Chanute, Kansas, Forenede Stater, 66720
- Cancer Center of Kansas - Chanute
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Dodge City, Kansas, Forenede Stater, 67801
- Cancer Center of Kansas - Dodge City
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El Dorado, Kansas, Forenede Stater, 67042
- Cancer Center of Kansas, P.A. - El Dorado
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Kingman, Kansas, Forenede Stater, 67068
- Cancer Center of Kansas - Kingman
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Liberal, Kansas, Forenede Stater, 67901
- Southwest Medical Center
-
Newton, Kansas, Forenede Stater, 67114
- Cancer Center of Kansas - Newton
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Parsons, Kansas, Forenede Stater, 67357
- Cancer Center of Kansas, P.A. - Parsons
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Pratt, Kansas, Forenede Stater, 67124
- Pratt Cancer Center of Kansas
-
Salina, Kansas, Forenede Stater, 67042
- Cancer Center of Kansas - Salina
-
Wellington, Kansas, Forenede Stater, 67152
- Cancer Center of Kansas - Wellington
-
Wichita, Kansas, Forenede Stater, 67214
- CCOP - Wichita
-
Wichita, Kansas, Forenede Stater, 67214
- Via Christi Cancer Center at Via Christi Regional Medical Center
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Wichita, Kansas, Forenede Stater, 67203
- Associates In Womens Health
-
Wichita, Kansas, Forenede Stater, 67208
- Cancer Center of Kansas, P.A.
-
Wichita, Kansas, Forenede Stater, 67214
- Cancer Center of Kansas, P.A. - Wichita
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Winfield, Kansas, Forenede Stater, 67156
- Cancer Center of Kansas - Winfield
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Michigan
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Adrian, Michigan, Forenede Stater, 49221
- Hickman Cancer Center at Bixby Medical Center
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Escanaba, Michigan, Forenede Stater, 49431
- Green Bay Oncology, Limited - Escanaba
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Iron Mountain, Michigan, Forenede Stater, 49801
- Green Bay Oncology, Limited - Iron Mountain
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Lambertville, Michigan, Forenede Stater, 48144
- Haematology-Oncology Associates of Ohio and Michigan, P.C.
-
Monroe, Michigan, Forenede Stater, 48162
- Community Cancer Center of Monroe
-
Monroe, Michigan, Forenede Stater, 48162
- Mercy Memorial Hospital System
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Minnesota
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Bemidji, Minnesota, Forenede Stater, 56601
- MeritCare Clinic - Bemidji
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Brainerd, Minnesota, Forenede Stater, 56401
- Brainerd Medical Center
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Brainerd, Minnesota, Forenede Stater, 56401
- St. Joseph's Medical Center
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Burnsville, Minnesota, Forenede Stater, 55337
- Fairview Ridges Hospital
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Coon Rapids, Minnesota, Forenede Stater, 55433
- Mercy and Unity Cancer Center at Mercy Hospital
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Duluth, Minnesota, Forenede Stater, 55805
- CCOP - Duluth
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Duluth, Minnesota, Forenede Stater, 55805
- St. Mary's - Duluth Clinic Cancer Center
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Duluth, Minnesota, Forenede Stater, 55805
- Miller-Dwan Medical Center
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Edina, Minnesota, Forenede Stater, 55435
- Fairview Southdale Hospital
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Fridley, Minnesota, Forenede Stater, 55432
- Mercy and Unity Cancer Center at Unity Hospital
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Minneapolis, Minnesota, Forenede Stater, 55403
- Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
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Montevideo, Minnesota, Forenede Stater, 56265
- Chippewa County - Montevideo Hospital
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Robbinsdale, Minnesota, Forenede Stater, 55422
- Hubert H. Humphrey Cancer Center at North Memorial Medical Center
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Rochester, Minnesota, Forenede Stater, 55905
- Mayo Clinic Cancer Center
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Saint Cloud, Minnesota, Forenede Stater, 56303
- St. Cloud Hospital
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Saint Louis Park, Minnesota, Forenede Stater, 55416
- CCOP - Metro-Minnesota
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St. Cloud, Minnesota, Forenede Stater, 56303
- CentraCare Clinic - River Campus
-
St. Cloud, Minnesota, Forenede Stater, 56303
- Adult and Pediatric Urology, P.L.L.P.
-
St. Louis Park, Minnesota, Forenede Stater, 55416
- Park Nicollet Health Services
-
St. Paul, Minnesota, Forenede Stater, 55102
- United Hospital
-
Waconia, Minnesota, Forenede Stater, 55387
- Ridgeview Medical Center
-
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Montana
-
Billings, Montana, Forenede Stater, 59101
- CCOP - Montana Cancer Consortium
-
Billings, Montana, Forenede Stater, 59101
- Northern Rockies Radiation Oncology Center
-
Billings, Montana, Forenede Stater, 59101
- Deaconess Billings Clinic - Downtown
-
Billings, Montana, Forenede Stater, 59101
- St. Vincent Healthcare
-
Billings, Montana, Forenede Stater, 59107
- Deaconess Billings Clinic Cancer Center
-
Bozeman, Montana, Forenede Stater, 59715
- Bozeman Deaconess Hospital
-
Butte, Montana, Forenede Stater, 59701
- St. James Community Hospital
-
Great Falls, Montana, Forenede Stater, 59405
- Great Falls Clinic
-
Great Falls, Montana, Forenede Stater, 59405
- Sletten Regional Cancer Institute
-
Helena, Montana, Forenede Stater, 59601
- St. Peter's Hospital
-
Kalispell, Montana, Forenede Stater, 59901
- Kalispell Regional Medical Center
-
Miles City, Montana, Forenede Stater, 59301
- Eastern Montana Cancer Center
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Missoula, Montana, Forenede Stater, 59801
- Community Medical Center
-
Missoula, Montana, Forenede Stater, 59802
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
-
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Nebraska
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Fremont, Nebraska, Forenede Stater, 68025
- Fremont Area Medical Center
-
Omaha, Nebraska, Forenede Stater, 68131
- Creighton University Medical Center
-
Omaha, Nebraska, Forenede Stater, 68106
- CCOP - Missouri Valley Cancer Consortium
-
Omaha, Nebraska, Forenede Stater, 68122
- Immanuel Medical Center
-
Omaha, Nebraska, Forenede Stater, 68124
- Bergan Mercy Medical Center
-
Papillion, Nebraska, Forenede Stater, 68046
- Midlands Cancer Center at Midlands Community Hospital
-
-
North Carolina
-
Rutherfordton, North Carolina, Forenede Stater, 28139
- Rutherford Hospital
-
-
North Dakota
-
Bismarck, North Dakota, Forenede Stater, 58501
- Mid Dakota Clinic, P.C.
-
Bismarck, North Dakota, Forenede Stater, 58501
- Bismarck Cancer Center
-
Bismarck, North Dakota, Forenede Stater, 58501
- Cancer Care Center at Medcenter One Hospital
-
Bismarck, North Dakota, Forenede Stater, 58501
- St. Alexius Medical Center
-
Fargo, North Dakota, Forenede Stater, 58122
- CCOP - MeritCare Hospital
-
Fargo, North Dakota, Forenede Stater, 58122
- MeritCare Medical Group
-
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Ohio
-
Bowling Green, Ohio, Forenede Stater, 43402
- Wood County Oncology Center
-
Dayton, Ohio, Forenede Stater, 45428
- Veterans Affairs Medical Center - Dayton
-
Dayton, Ohio, Forenede Stater, 45405
- Grandview Hospital
-
Dayton, Ohio, Forenede Stater, 45406
- Good Samaritan Hospital
-
Dayton, Ohio, Forenede Stater, 45409
- David L. Rike Cancer Center at Miami Valley Hospital
-
Dayton, Ohio, Forenede Stater, 45415
- Samaritan North Cancer Care Center
-
Dayton, Ohio, Forenede Stater, 45429
- CCOP - Dayton
-
Findlay, Ohio, Forenede Stater, 45840
- Blanchard Valley Medical Associates
-
Fremont, Ohio, Forenede Stater, 43420
- Fremont Memorial Hospital
-
Kenton, Ohio, Forenede Stater, 43326
- Kenton Oncology, Incorporated
-
Kettering, Ohio, Forenede Stater, 45429
- Charles F. Kettering Memorial Hospital
-
Lima, Ohio, Forenede Stater, 45804
- Lima Memorial Hospital
-
Maumee, Ohio, Forenede Stater, 43537
- Northwest Ohio Oncology Center
-
Maumee, Ohio, Forenede Stater, 43537
- St. Luke's Hospital
-
Middletown, Ohio, Forenede Stater, 45044
- Middletown Regional Hospital
-
Oregon, Ohio, Forenede Stater, 43616
- St. Charles Mercy Hospital
-
Oregon, Ohio, Forenede Stater, 43616
- Toledo Clinic - Oregon
-
Sandusky, Ohio, Forenede Stater, 44870
- Firelands Regional Medical Center
-
Sandusky, Ohio, Forenede Stater, 44870
- North Coast Cancer Care, Incorporated
-
Sylvania, Ohio, Forenede Stater, 43560
- Promedica Cancer Center at Flower Hospital
-
Tiffin, Ohio, Forenede Stater, 44883
- Mercy Hospital of Tiffin
-
Toledo, Ohio, Forenede Stater, 43608
- St. Vincent Mercy Medical Center
-
Toledo, Ohio, Forenede Stater, 43606
- Toledo Hospital
-
Toledo, Ohio, Forenede Stater, 43623
- CCOP - Toledo Community Hospital
-
Toledo, Ohio, Forenede Stater, 43614
- Medical College of Ohio Cancer Institute
-
Toledo, Ohio, Forenede Stater, 43623
- Toledo Surgical Specialists
-
Toledo, Ohio, Forenede Stater, 43623
- Toledo Clinic, Incorporated
-
Troy, Ohio, Forenede Stater, 45373
- UVMC Cancer Care Center at Upper Valley Medical Center
-
Wauseon, Ohio, Forenede Stater, 43567
- Fulton County Health Center
-
Wright-Patterson Afb, Ohio, Forenede Stater, 45433-5529
- United States Air Force Medical Center Wright-Patterson
-
Xenia, Ohio, Forenede Stater, 45385
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
-
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Oklahoma
-
Tulsa, Oklahoma, Forenede Stater, 74136
- Natalie Warren Bryant Cancer Center at St. Francis Hospital
-
-
Pennsylvania
-
Danville, Pennsylvania, Forenede Stater, 17822-2001
- Geisinger Medical Center
-
State College, Pennsylvania, Forenede Stater, 16801
- Geisinger Medical Group
-
Wilkes-Barre, Pennsylvania, Forenede Stater, 18711
- Geisinger Wyoming Valley Medical Center
-
-
South Carolina
-
Anderson, South Carolina, Forenede Stater, 29621
- Rose Ramer Cancer Clinic at Anderson Area Medical Center
-
Spartanburg, South Carolina, Forenede Stater, 29303
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
-
Spartanburg, South Carolina, Forenede Stater, 29304
- CCOP - Upstate Carolina
-
-
South Dakota
-
Sioux Falls, South Dakota, Forenede Stater, 57105
- Medical X-Ray Center
-
Sioux Falls, South Dakota, Forenede Stater, 57104
- Sioux Valley Hospital and University of South Dakota Medical Center
-
Sioux Falls, South Dakota, Forenede Stater, 57105
- Avera McKennan Hospital and University Health Center
-
-
Wisconsin
-
Eau Claire, Wisconsin, Forenede Stater, 54702
- Luther Mildelfort Hospital
-
Eau Claire, Wisconsin, Forenede Stater, 54702
- Midelfort Clinic - Luther
-
Green Bay, Wisconsin, Forenede Stater, 54303
- Green Bay Oncology, Limited at St. Mary's Hospital
-
Green Bay, Wisconsin, Forenede Stater, 54301-3526
- Green Bay Oncology, Limited at St. Vincent Hospital
-
Green Bay, Wisconsin, Forenede Stater, 54301
- St. Vincent Hospital
-
Green Bay, Wisconsin, Forenede Stater, 54303
- St. Mary's Hospital Medical Center
-
La Crosse, Wisconsin, Forenede Stater, 54601
- Franciscan Skemp Healthcare
-
Oconto Falls, Wisconsin, Forenede Stater, 54154
- Green Bay Oncology, Limited - Oconto Falls
-
Sturgeon Bay, Wisconsin, Forenede Stater, 54235
- Green Bay Oncology, Limited - Sturgeon Bay
-
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Wyoming
-
Sheridan, Wyoming, Forenede Stater, 82801
- Welch Cancer Center
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed unresectable non-small cell lung cancer that is considered incurable with other therapies
- Chemotherapy naive or previously treated disease
Meets one of the following criteria:
- Age 65 and over with ECOG performance status of 0-2
- Under age 65 with ECOG performance status of 2
- No symptomatic or known untreated brain metastases
PATIENT CHARACTERISTICS:
Age:
- See Disease Characteristics
- Adult
Performance status:
- See Disease Characteristics
- ECOG 0-2
Life expectancy:
- At least 3 months
Hematopoietic:
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
Hepatic:
- Bilirubin normal
- AST and/or ALT ≤ 2.5 times upper limit of normal (ULN) if alkaline phosphatase less than ULN OR
- Alkaline phosphatase ≤ 4 times ULN if ALT less than ULN
- No ascites
Renal:
- Creatinine ≤ 1.5 times ULN
Cardiovascular:
- No prior or concurrent congestive heart failure
Pulmonary:
- No prior tuberculosis or positive purified protein derivative skin test (tuberculin test)
Other:
- No prior anaphylactic reaction to any taxane
- No known mechanical obstruction of the alimentary tract, malabsorption, or intractable vomiting (more than 5 episodes per week)
- No infection or chronic debilitating illness that would increase the risk of chemotherapy administration
- No grade 2 or greater peripheral neuropathy of any etiology
- No edema
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer
- Alert and mentally competent
- Able to complete questionnaires alone or with assistance
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- See Disease Characteristics
- No prior docetaxel for metastatic non-small cell lung cancer
Endocrine therapy:
- At least 1 month since prior adrenal steroids, androgens, progestational agents, or appetite stimulants
- No concurrent adrenal steroids, androgens, progestational agents, or appetite stimulants unless needed (e.g., steroids for CNS metastases)
- Concurrent inhaled, topical, or optical steroids allowed
- Concurrent short-term dexamethasone around days of chemotherapy administration allowed for protection against anaphylaxis and emesis
Radiotherapy:
- More than 3 weeks since prior radiotherapy
- No prior radiotherapy to more than 25% of bone marrow
Surgery:
- More than 3 weeks since prior major surgery
Other:
- More than 3 weeks since other prior antineoplastic therapy
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: infliximab + docetaxel
Patients receive infliximab IV over 2 hours once weekly on weeks 1, 3, and 5 of the first course and once weekly on weeks 1 and 5 of all subsequent courses and docetaxel IV over 1 hour (immediately after completion of infliximab infusion once weekly on weeks 1-6 of each course. Treatment repeats every 8 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Quality of life, fatigue, appetite/anorexia, cachexia, and weight are assessed at baseline, weekly on weeks 1-8, and then monthly for the remainder of study treatment. Patients are followed every 6 months for 5 years. |
|
|
Aktiv komparator: placebo + docetaxel
Patients receive docetaxel IV over 1 hour (immediately after completion of infliximab infusion once weekly on weeks 1-6 of each course. Patients receive placebo IV over 2 hours once weekly on weeks 1, 3, and 5 of the first course and once weekly on weeks 1 and 5 of all subsequent courses. Treatment repeats every 8 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity. Quality of life, fatigue, appetite/anorexia, cachexia, and weight are assessed at baseline, weekly on weeks 1-8, and then monthly for the remainder of study treatment. Patients are followed every 6 months for 5 years. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Assessment of weight
Tidsramme: Up to 5 years
|
Up to 5 years
|
|
Rate of weight change
Tidsramme: Up to 5 years
|
Up to 5 years
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Samlet overlevelse
Tidsramme: Op til 5 år
|
Op til 5 år
|
|
Livskvalitet
Tidsramme: Op til 5 år
|
Op til 5 år
|
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Forekomst af behandlingsrelateret toksicitet
Tidsramme: Op til 5 år
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Op til 5 år
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Cancer-related fatigue as measured by the Brief Fatigue Inventory
Tidsramme: Up to 5 years
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Up to 5 years
|
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Time-to-weight decline
Tidsramme: Up to 5 years
|
Up to 5 years
|
|
Appetite
Tidsramme: Up to 5 years
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Up to 5 years
|
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Lean tissue changes
Tidsramme: Up to 5 years
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Up to 5 years
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. oktober 2002
Primær færdiggørelse (Faktiske)
1. februar 2006
Studieafslutning (Faktiske)
1. oktober 2008
Datoer for studieregistrering
Først indsendt
8. juli 2002
Først indsendt, der opfyldte QC-kriterier
26. januar 2003
Først opslået (Skøn)
27. januar 2003
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
7. december 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
5. december 2016
Sidst verificeret
1. december 2016
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Metaboliske sygdomme
- Luftvejssygdomme
- Neoplasmer
- Lungesygdomme
- Neoplasmer efter sted
- Tegn og symptomer, fordøjelsessystemet
- Ernæringsforstyrrelser
- Kropsvægt
- Neoplasmer i luftvejene
- Thoracale neoplasmer
- Karcinom, bronkogent
- Bronkiale neoplasmer
- Ændringer i kropsvægt
- Afmagring
- Vægttab
- Anoreksi
- Træthed
- Lungeneoplasmer
- Karcinom, ikke-småcellet lunge
- Wasting syndrom
- Kakeksi
- Molekylære mekanismer for farmakologisk virkning
- Antirheumatiske midler
- Antineoplastiske midler
- Tubulin modulatorer
- Antimitotiske midler
- Mitose modulatorer
- Gastrointestinale midler
- Dermatologiske midler
- Docetaxel
- Infliximab
Andre undersøgelses-id-numre
- NCCTG-N01C9
- NCI-2012-02472 (Registry Identifier: CTRP (Clinical Trials Reporting System))
- NCI-P02-0226
- CDR0000069417 (Registry Identifier: PDQ (Physician Data Query))
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .