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 décembre 2016 mis à jour par: 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)
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
67
Phase
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
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Arizona
-
Scottsdale, Arizona, États-Unis, 85259
- CCOP - Mayo Clinic Scottsdale Oncology Program
-
-
Colorado
-
Aurora, Colorado, États-Unis, 80012
- Aurora Presbyterian Hospital
-
Boulder, Colorado, États-Unis, 80301
- Boulder Community Hospital
-
Colorado Springs, Colorado, États-Unis, 80933
- Penrose Cancer Center at Penrose Hospital
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Denver, Colorado, États-Unis, 80210
- Porter Adventist Hospital
-
Denver, Colorado, États-Unis, 80220
- Rose Medical Center
-
Denver, Colorado, États-Unis, 80218
- Presbyterian - St. Luke's Medical Center
-
Denver, Colorado, États-Unis, 80218
- St. Joseph Hospital
-
Denver, Colorado, États-Unis, 80224-2522
- CCOP - Colorado Cancer Research Program, Incorporated
-
Englewood, Colorado, États-Unis, 80110
- Swedish Medical Center
-
Lone Tree, Colorado, États-Unis, 80124
- Sky Ridge Medical Center
-
Longmont, Colorado, États-Unis, 80502
- Hope Cancer Care Center at Longmont United Hospital
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Pueblo, Colorado, États-Unis, 81004
- St. Mary-Corwin Regional Medical Center
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Thorton, Colorado, États-Unis, 80229
- North Suburban Medical Center
-
-
Florida
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Jacksonville, Florida, États-Unis, 32224-9980
- Mayo Clinic - Jacksonville
-
-
Illinois
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Aurora, Illinois, États-Unis, 60507
- Rush-Copley Cancer Care Center
-
Bloomington, Illinois, États-Unis, 61701
- St. Joseph Medical Center
-
Canton, Illinois, États-Unis, 61520
- Graham Hospital
-
Carthage, Illinois, États-Unis, 62321
- Memorial Hospital
-
Eureka, Illinois, États-Unis, 61530
- Eureka Community Hospital
-
Galesburg, Illinois, États-Unis, 61401
- Galesburg Cottage Hospital
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Galesburg, Illinois, États-Unis, 61401
- Galesburg Clinic
-
Galesburg, Illinois, États-Unis, 61401
- InterCommunity Cancer Center of Western Illinois
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Havana, Illinois, États-Unis, 62644
- Mason District Hospital
-
Hopedale, Illinois, États-Unis, 61747
- Hopedale Medical Complex
-
Joliet, Illinois, États-Unis, 60435
- Joliet Oncology Hematology Associates, Limited - West
-
Kewanee, Illinois, États-Unis, 61443
- Kewanee Hospital
-
Macomb, Illinois, États-Unis, 61455
- Mcdonough District Hospital
-
Normal, Illinois, États-Unis, 61761
- Bromenn Regional Medical Center
-
Normal, Illinois, États-Unis, 61761
- Community Cancer Center
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Ottawa, Illinois, États-Unis, 61350
- Community Hospital of Ottawa
-
Ottawa, Illinois, États-Unis, 61350
- Oncology Hematology Associates of Central Illinois - Ottawa
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Pekin, Illinois, États-Unis, 61554
- Cancer Treatment Center at Pekin Hospital
-
Peoria, Illinois, États-Unis, 61614
- Proctor Hospital
-
Peoria, Illinois, États-Unis, 61603
- Methodist Medical Center of Illinois
-
Peoria, Illinois, États-Unis, 61637
- OSF St. Francis Medical Center
-
Peoria, Illinois, États-Unis, 61615
- CCOP - Illinois Oncology Research Association
-
Peoria, Illinois, États-Unis, 61615
- Oncology/Hematology Associates of Central Illinois, P.C.
-
Peru, Illinois, États-Unis, 61354
- Illinois Valley Community Hospital
-
Princeton, Illinois, États-Unis, 61356
- Perry Memorial Hospital
-
Spring Valley, Illinois, États-Unis, 61362
- St. Margaret's Hospital
-
Spring Valley, Illinois, États-Unis, 61362
- Valley Cancer Center
-
Urbana, Illinois, États-Unis, 61801
- Carle Cancer Center at Carle Foundation Hospital
-
Urbana, Illinois, États-Unis, 61801
- CCOP - Carle Cancer Center
-
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Indiana
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Beech Grove, Indiana, États-Unis, 46107
- St. Francis Hospital and Health Centers
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Michigan City, Indiana, États-Unis, 46360
- Saint Anthony Memorial Health Centers
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Iowa
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Carroll, Iowa, États-Unis, 51401
- Saint Anthony Regional Hospital
-
Cedar Rapids, Iowa, États-Unis, 52402
- St. Luke's Hospital
-
Cedar Rapids, Iowa, États-Unis, 52403
- Cedar Rapids Oncology Associates
-
Cedar Rapids, Iowa, États-Unis, 52403
- Mercy Cancer Center at Mercy Medical Center
-
Council Bluffs, Iowa, États-Unis, 51503
- Alegent Health Mercy Hospital
-
Des Moines, Iowa, États-Unis, 50309
- CCOP - Iowa Oncology Research Association
-
Des Moines, Iowa, États-Unis, 50309
- John Stoddard Cancer Center at Iowa Methodist Medical Center
-
Des Moines, Iowa, États-Unis, 50309
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
-
Des Moines, Iowa, États-Unis, 50314
- Medical Oncology and Hematology Associates at Mercy Cancer Center
-
Des Moines, Iowa, États-Unis, 50314
- Mercy Cancer Center at Mercy Medical Center - Des Moines
-
Des Moines, Iowa, États-Unis, 50316
- John Stoddard Cancer Center at Iowa Lutheran Hospital
-
Des Moines, Iowa, États-Unis, 50307
- Mercy Capitol Hospital
-
Mason City, Iowa, États-Unis, 50401
- Mercy Cancer Center at Mercy Medical Center - North Iowa
-
Missouri Valley, Iowa, États-Unis, 51555
- Alegent Health Community Memorial Hospital
-
Onawa, Iowa, États-Unis, 51040
- Burgess Health Center
-
Ottumwa, Iowa, États-Unis, 52501
- Ottumwa Regional Health Center Cancer Center
-
Sioux City, Iowa, États-Unis, 51101-1733
- Siouxland Regional Cancer Center
-
Sioux City, Iowa, États-Unis, 51104
- St. Luke's Regional Medical Center
-
Sioux City, Iowa, États-Unis, 51104
- Mercy Medical Center - Sioux City
-
Sioux City, Iowa, États-Unis, 51101
- Siouxland Hematology-Oncology Associates
-
West Des Moines, Iowa, États-Unis, 50266
- Medical Oncology and Hematology Associates - West Des Moines
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Kansas
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Chanute, Kansas, États-Unis, 66720
- Cancer Center of Kansas - Chanute
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Dodge City, Kansas, États-Unis, 67801
- Cancer Center of Kansas - Dodge City
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El Dorado, Kansas, États-Unis, 67042
- Cancer Center of Kansas, P.A. - El Dorado
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Kingman, Kansas, États-Unis, 67068
- Cancer Center of Kansas - Kingman
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Liberal, Kansas, États-Unis, 67901
- Southwest Medical Center
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Newton, Kansas, États-Unis, 67114
- Cancer Center of Kansas - Newton
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Parsons, Kansas, États-Unis, 67357
- Cancer Center of Kansas, P.A. - Parsons
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Pratt, Kansas, États-Unis, 67124
- Pratt Cancer Center of Kansas
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Salina, Kansas, États-Unis, 67042
- Cancer Center of Kansas - Salina
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Wellington, Kansas, États-Unis, 67152
- Cancer Center of Kansas - Wellington
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Wichita, Kansas, États-Unis, 67214
- CCOP - Wichita
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Wichita, Kansas, États-Unis, 67214
- Via Christi Cancer Center at Via Christi Regional Medical Center
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Wichita, Kansas, États-Unis, 67203
- Associates In Womens Health
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Wichita, Kansas, États-Unis, 67208
- Cancer Center of Kansas, P.A.
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Wichita, Kansas, États-Unis, 67214
- Cancer Center of Kansas, P.A. - Wichita
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Winfield, Kansas, États-Unis, 67156
- Cancer Center of Kansas - Winfield
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Michigan
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Adrian, Michigan, États-Unis, 49221
- Hickman Cancer Center at Bixby Medical Center
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Escanaba, Michigan, États-Unis, 49431
- Green Bay Oncology, Limited - Escanaba
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Iron Mountain, Michigan, États-Unis, 49801
- Green Bay Oncology, Limited - Iron Mountain
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Lambertville, Michigan, États-Unis, 48144
- Haematology-Oncology Associates of Ohio and Michigan, P.C.
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Monroe, Michigan, États-Unis, 48162
- Community Cancer Center of Monroe
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Monroe, Michigan, États-Unis, 48162
- Mercy Memorial Hospital System
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Minnesota
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Bemidji, Minnesota, États-Unis, 56601
- MeritCare Clinic - Bemidji
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Brainerd, Minnesota, États-Unis, 56401
- Brainerd Medical Center
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Brainerd, Minnesota, États-Unis, 56401
- St. Joseph's Medical Center
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Burnsville, Minnesota, États-Unis, 55337
- Fairview Ridges Hospital
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Coon Rapids, Minnesota, États-Unis, 55433
- Mercy and Unity Cancer Center at Mercy Hospital
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Duluth, Minnesota, États-Unis, 55805
- CCOP - Duluth
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Duluth, Minnesota, États-Unis, 55805
- St. Mary's - Duluth Clinic Cancer Center
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Duluth, Minnesota, États-Unis, 55805
- Miller-Dwan Medical Center
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Edina, Minnesota, États-Unis, 55435
- Fairview Southdale Hospital
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Fridley, Minnesota, États-Unis, 55432
- Mercy and Unity Cancer Center at Unity Hospital
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Minneapolis, Minnesota, États-Unis, 55403
- Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
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Montevideo, Minnesota, États-Unis, 56265
- Chippewa County - Montevideo Hospital
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Robbinsdale, Minnesota, États-Unis, 55422
- Hubert H. Humphrey Cancer Center at North Memorial Medical Center
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Rochester, Minnesota, États-Unis, 55905
- Mayo Clinic Cancer Center
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Saint Cloud, Minnesota, États-Unis, 56303
- St. Cloud Hospital
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Saint Louis Park, Minnesota, États-Unis, 55416
- CCOP - Metro-Minnesota
-
St. Cloud, Minnesota, États-Unis, 56303
- CentraCare Clinic - River Campus
-
St. Cloud, Minnesota, États-Unis, 56303
- Adult and Pediatric Urology, P.L.L.P.
-
St. Louis Park, Minnesota, États-Unis, 55416
- Park Nicollet Health Services
-
St. Paul, Minnesota, États-Unis, 55102
- United Hospital
-
Waconia, Minnesota, États-Unis, 55387
- Ridgeview Medical Center
-
-
Montana
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Billings, Montana, États-Unis, 59101
- CCOP - Montana Cancer Consortium
-
Billings, Montana, États-Unis, 59101
- Northern Rockies Radiation Oncology Center
-
Billings, Montana, États-Unis, 59101
- Deaconess Billings Clinic - Downtown
-
Billings, Montana, États-Unis, 59101
- St. Vincent Healthcare
-
Billings, Montana, États-Unis, 59107
- Deaconess Billings Clinic Cancer Center
-
Bozeman, Montana, États-Unis, 59715
- Bozeman Deaconess Hospital
-
Butte, Montana, États-Unis, 59701
- St. James Community Hospital
-
Great Falls, Montana, États-Unis, 59405
- Great Falls Clinic
-
Great Falls, Montana, États-Unis, 59405
- Sletten Regional Cancer Institute
-
Helena, Montana, États-Unis, 59601
- St. Peter's Hospital
-
Kalispell, Montana, États-Unis, 59901
- Kalispell Regional Medical Center
-
Miles City, Montana, États-Unis, 59301
- Eastern Montana Cancer Center
-
Missoula, Montana, États-Unis, 59801
- Community Medical Center
-
Missoula, Montana, États-Unis, 59802
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
-
-
Nebraska
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Fremont, Nebraska, États-Unis, 68025
- Fremont Area Medical Center
-
Omaha, Nebraska, États-Unis, 68131
- Creighton University Medical Center
-
Omaha, Nebraska, États-Unis, 68106
- CCOP - Missouri Valley Cancer Consortium
-
Omaha, Nebraska, États-Unis, 68122
- Immanuel Medical Center
-
Omaha, Nebraska, États-Unis, 68124
- Bergan Mercy Medical Center
-
Papillion, Nebraska, États-Unis, 68046
- Midlands Cancer Center at Midlands Community Hospital
-
-
North Carolina
-
Rutherfordton, North Carolina, États-Unis, 28139
- Rutherford Hospital
-
-
North Dakota
-
Bismarck, North Dakota, États-Unis, 58501
- Mid Dakota Clinic, P.C.
-
Bismarck, North Dakota, États-Unis, 58501
- Bismarck Cancer Center
-
Bismarck, North Dakota, États-Unis, 58501
- Cancer Care Center at Medcenter One Hospital
-
Bismarck, North Dakota, États-Unis, 58501
- St. Alexius Medical Center
-
Fargo, North Dakota, États-Unis, 58122
- CCOP - MeritCare Hospital
-
Fargo, North Dakota, États-Unis, 58122
- MeritCare Medical Group
-
-
Ohio
-
Bowling Green, Ohio, États-Unis, 43402
- Wood County Oncology Center
-
Dayton, Ohio, États-Unis, 45428
- Veterans Affairs Medical Center - Dayton
-
Dayton, Ohio, États-Unis, 45405
- Grandview Hospital
-
Dayton, Ohio, États-Unis, 45406
- Good Samaritan Hospital
-
Dayton, Ohio, États-Unis, 45409
- David L. Rike Cancer Center at Miami Valley Hospital
-
Dayton, Ohio, États-Unis, 45415
- Samaritan North Cancer Care Center
-
Dayton, Ohio, États-Unis, 45429
- CCOP - Dayton
-
Findlay, Ohio, États-Unis, 45840
- Blanchard Valley Medical Associates
-
Fremont, Ohio, États-Unis, 43420
- Fremont Memorial Hospital
-
Kenton, Ohio, États-Unis, 43326
- Kenton Oncology, Incorporated
-
Kettering, Ohio, États-Unis, 45429
- Charles F. Kettering Memorial Hospital
-
Lima, Ohio, États-Unis, 45804
- Lima Memorial Hospital
-
Maumee, Ohio, États-Unis, 43537
- Northwest Ohio Oncology Center
-
Maumee, Ohio, États-Unis, 43537
- St. Luke's Hospital
-
Middletown, Ohio, États-Unis, 45044
- Middletown Regional Hospital
-
Oregon, Ohio, États-Unis, 43616
- St. Charles Mercy Hospital
-
Oregon, Ohio, États-Unis, 43616
- Toledo Clinic - Oregon
-
Sandusky, Ohio, États-Unis, 44870
- Firelands Regional Medical Center
-
Sandusky, Ohio, États-Unis, 44870
- North Coast Cancer Care, Incorporated
-
Sylvania, Ohio, États-Unis, 43560
- Promedica Cancer Center at Flower Hospital
-
Tiffin, Ohio, États-Unis, 44883
- Mercy Hospital of Tiffin
-
Toledo, Ohio, États-Unis, 43608
- St. Vincent Mercy Medical Center
-
Toledo, Ohio, États-Unis, 43606
- Toledo Hospital
-
Toledo, Ohio, États-Unis, 43623
- CCOP - Toledo Community Hospital
-
Toledo, Ohio, États-Unis, 43614
- Medical College of Ohio Cancer Institute
-
Toledo, Ohio, États-Unis, 43623
- Toledo Surgical Specialists
-
Toledo, Ohio, États-Unis, 43623
- Toledo Clinic, Incorporated
-
Troy, Ohio, États-Unis, 45373
- UVMC Cancer Care Center at Upper Valley Medical Center
-
Wauseon, Ohio, États-Unis, 43567
- Fulton County Health Center
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Wright-Patterson Afb, Ohio, États-Unis, 45433-5529
- United States Air Force Medical Center Wright-Patterson
-
Xenia, Ohio, États-Unis, 45385
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
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Oklahoma
-
Tulsa, Oklahoma, États-Unis, 74136
- Natalie Warren Bryant Cancer Center at St. Francis Hospital
-
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Pennsylvania
-
Danville, Pennsylvania, États-Unis, 17822-2001
- Geisinger Medical Center
-
State College, Pennsylvania, États-Unis, 16801
- Geisinger Medical Group
-
Wilkes-Barre, Pennsylvania, États-Unis, 18711
- Geisinger Wyoming Valley Medical Center
-
-
South Carolina
-
Anderson, South Carolina, États-Unis, 29621
- Rose Ramer Cancer Clinic at Anderson Area Medical Center
-
Spartanburg, South Carolina, États-Unis, 29303
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
-
Spartanburg, South Carolina, États-Unis, 29304
- CCOP - Upstate Carolina
-
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South Dakota
-
Sioux Falls, South Dakota, États-Unis, 57105
- Medical X-Ray Center
-
Sioux Falls, South Dakota, États-Unis, 57104
- Sioux Valley Hospital and University of South Dakota Medical Center
-
Sioux Falls, South Dakota, États-Unis, 57105
- Avera McKennan Hospital and University Health Center
-
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Wisconsin
-
Eau Claire, Wisconsin, États-Unis, 54702
- Luther Mildelfort Hospital
-
Eau Claire, Wisconsin, États-Unis, 54702
- Midelfort Clinic - Luther
-
Green Bay, Wisconsin, États-Unis, 54303
- Green Bay Oncology, Limited at St. Mary's Hospital
-
Green Bay, Wisconsin, États-Unis, 54301-3526
- Green Bay Oncology, Limited at St. Vincent Hospital
-
Green Bay, Wisconsin, États-Unis, 54301
- St. Vincent Hospital
-
Green Bay, Wisconsin, États-Unis, 54303
- St. Mary's Hospital Medical Center
-
La Crosse, Wisconsin, États-Unis, 54601
- Franciscan Skemp Healthcare
-
Oconto Falls, Wisconsin, États-Unis, 54154
- Green Bay Oncology, Limited - Oconto Falls
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Sturgeon Bay, Wisconsin, États-Unis, 54235
- Green Bay Oncology, Limited - Sturgeon Bay
-
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Wyoming
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Sheridan, Wyoming, États-Unis, 82801
- Welch Cancer Center
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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. |
|
|
Comparateur actif: 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Assessment of weight
Délai: Up to 5 years
|
Up to 5 years
|
|
Rate of weight change
Délai: Up to 5 years
|
Up to 5 years
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
La survie globale
Délai: Jusqu'à 5 ans
|
Jusqu'à 5 ans
|
|
Qualité de vie
Délai: Jusqu'à 5 ans
|
Jusqu'à 5 ans
|
|
Incidence de la toxicité liée au traitement
Délai: Jusqu'à 5 ans
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Jusqu'à 5 ans
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Cancer-related fatigue as measured by the Brief Fatigue Inventory
Délai: Up to 5 years
|
Up to 5 years
|
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Time-to-weight decline
Délai: Up to 5 years
|
Up to 5 years
|
|
Appetite
Délai: Up to 5 years
|
Up to 5 years
|
|
Lean tissue changes
Délai: Up to 5 years
|
Up to 5 years
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 octobre 2002
Achèvement primaire (Réel)
1 février 2006
Achèvement de l'étude (Réel)
1 octobre 2008
Dates d'inscription aux études
Première soumission
8 juillet 2002
Première soumission répondant aux critères de contrôle qualité
26 janvier 2003
Première publication (Estimation)
27 janvier 2003
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
7 décembre 2016
Dernière mise à jour soumise répondant aux critères de contrôle qualité
5 décembre 2016
Dernière vérification
1 décembre 2016
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies métaboliques
- Maladies des voies respiratoires
- Tumeurs
- Maladies pulmonaires
- Tumeurs par site
- Signes et symptômes digestifs
- Troubles nutritionnels
- Poids
- Tumeurs des voies respiratoires
- Tumeurs thoraciques
- Carcinome bronchique
- Tumeurs bronchiques
- Changements de poids corporel
- Émaciation
- Perte de poids
- Anorexie
- Fatigue
- Tumeurs pulmonaires
- Carcinome pulmonaire non à petites cellules
- Syndrome de dépérissement
- Cachexie
- Mécanismes moléculaires de l'action pharmacologique
- Agents antirhumatismaux
- Agents antinéoplasiques
- Modulateurs de tubuline
- Agents antimitotiques
- Modulateurs de mitose
- Agents gastro-intestinaux
- Agents dermatologiques
- Docétaxel
- Infliximab
Autres numéros d'identification d'étude
- NCCTG-N01C9
- NCI-2012-02472 (Identificateur de registre: CTRP (Clinical Trials Reporting System))
- NCI-P02-0226
- CDR0000069417 (Identificateur de registre: PDQ (Physician Data Query))
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .