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 bijgewerkt door: 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)
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
67
Fase
- Fase 3
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Arizona
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Scottsdale, Arizona, Verenigde Staten, 85259
- CCOP - Mayo Clinic Scottsdale Oncology Program
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Colorado
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Aurora, Colorado, Verenigde Staten, 80012
- Aurora Presbyterian Hospital
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Boulder, Colorado, Verenigde Staten, 80301
- Boulder Community Hospital
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Colorado Springs, Colorado, Verenigde Staten, 80933
- Penrose Cancer Center at Penrose Hospital
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Denver, Colorado, Verenigde Staten, 80210
- Porter Adventist Hospital
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Denver, Colorado, Verenigde Staten, 80220
- Rose Medical Center
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Denver, Colorado, Verenigde Staten, 80218
- Presbyterian - St. Luke's Medical Center
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Denver, Colorado, Verenigde Staten, 80218
- St. Joseph Hospital
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Denver, Colorado, Verenigde Staten, 80224-2522
- CCOP - Colorado Cancer Research Program, Incorporated
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Englewood, Colorado, Verenigde Staten, 80110
- Swedish Medical Center
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Lone Tree, Colorado, Verenigde Staten, 80124
- Sky Ridge Medical Center
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Longmont, Colorado, Verenigde Staten, 80502
- Hope Cancer Care Center at Longmont United Hospital
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Pueblo, Colorado, Verenigde Staten, 81004
- St. Mary-Corwin Regional Medical Center
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Thorton, Colorado, Verenigde Staten, 80229
- North Suburban Medical Center
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Florida
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Jacksonville, Florida, Verenigde Staten, 32224-9980
- Mayo Clinic - Jacksonville
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Illinois
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Aurora, Illinois, Verenigde Staten, 60507
- Rush-Copley Cancer Care Center
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Bloomington, Illinois, Verenigde Staten, 61701
- St. Joseph Medical Center
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Canton, Illinois, Verenigde Staten, 61520
- Graham Hospital
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Carthage, Illinois, Verenigde Staten, 62321
- Memorial Hospital
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Eureka, Illinois, Verenigde Staten, 61530
- Eureka Community Hospital
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Galesburg, Illinois, Verenigde Staten, 61401
- Galesburg Cottage Hospital
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Galesburg, Illinois, Verenigde Staten, 61401
- Galesburg Clinic
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Galesburg, Illinois, Verenigde Staten, 61401
- InterCommunity Cancer Center of Western Illinois
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Havana, Illinois, Verenigde Staten, 62644
- Mason District Hospital
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Hopedale, Illinois, Verenigde Staten, 61747
- Hopedale Medical Complex
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Joliet, Illinois, Verenigde Staten, 60435
- Joliet Oncology Hematology Associates, Limited - West
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Kewanee, Illinois, Verenigde Staten, 61443
- Kewanee Hospital
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Macomb, Illinois, Verenigde Staten, 61455
- Mcdonough District Hospital
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Normal, Illinois, Verenigde Staten, 61761
- Bromenn Regional Medical Center
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Normal, Illinois, Verenigde Staten, 61761
- Community Cancer Center
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Ottawa, Illinois, Verenigde Staten, 61350
- Community Hospital of Ottawa
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Ottawa, Illinois, Verenigde Staten, 61350
- Oncology Hematology Associates of Central Illinois - Ottawa
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Pekin, Illinois, Verenigde Staten, 61554
- Cancer Treatment Center at Pekin Hospital
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Peoria, Illinois, Verenigde Staten, 61614
- Proctor Hospital
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Peoria, Illinois, Verenigde Staten, 61603
- Methodist Medical Center of Illinois
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Peoria, Illinois, Verenigde Staten, 61637
- OSF St. Francis Medical Center
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Peoria, Illinois, Verenigde Staten, 61615
- CCOP - Illinois Oncology Research Association
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Peoria, Illinois, Verenigde Staten, 61615
- Oncology/Hematology Associates of Central Illinois, P.C.
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Peru, Illinois, Verenigde Staten, 61354
- Illinois Valley Community Hospital
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Princeton, Illinois, Verenigde Staten, 61356
- Perry Memorial Hospital
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Spring Valley, Illinois, Verenigde Staten, 61362
- St. Margaret's Hospital
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Spring Valley, Illinois, Verenigde Staten, 61362
- Valley Cancer Center
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Urbana, Illinois, Verenigde Staten, 61801
- Carle Cancer Center at Carle Foundation Hospital
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Urbana, Illinois, Verenigde Staten, 61801
- CCOP - Carle Cancer Center
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Indiana
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Beech Grove, Indiana, Verenigde Staten, 46107
- St. Francis Hospital and Health Centers
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Michigan City, Indiana, Verenigde Staten, 46360
- Saint Anthony Memorial Health Centers
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Iowa
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Carroll, Iowa, Verenigde Staten, 51401
- Saint Anthony Regional Hospital
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Cedar Rapids, Iowa, Verenigde Staten, 52402
- St. Luke's Hospital
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Cedar Rapids, Iowa, Verenigde Staten, 52403
- Cedar Rapids Oncology Associates
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Cedar Rapids, Iowa, Verenigde Staten, 52403
- Mercy Cancer Center at Mercy Medical Center
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Council Bluffs, Iowa, Verenigde Staten, 51503
- Alegent Health Mercy Hospital
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Des Moines, Iowa, Verenigde Staten, 50309
- CCOP - Iowa Oncology Research Association
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Des Moines, Iowa, Verenigde Staten, 50309
- John Stoddard Cancer Center at Iowa Methodist Medical Center
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Des Moines, Iowa, Verenigde Staten, 50309
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
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Des Moines, Iowa, Verenigde Staten, 50314
- Medical Oncology and Hematology Associates at Mercy Cancer Center
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Des Moines, Iowa, Verenigde Staten, 50314
- Mercy Cancer Center at Mercy Medical Center - Des Moines
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Des Moines, Iowa, Verenigde Staten, 50316
- John Stoddard Cancer Center at Iowa Lutheran Hospital
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Des Moines, Iowa, Verenigde Staten, 50307
- Mercy Capitol Hospital
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Mason City, Iowa, Verenigde Staten, 50401
- Mercy Cancer Center at Mercy Medical Center - North Iowa
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Missouri Valley, Iowa, Verenigde Staten, 51555
- Alegent Health Community Memorial Hospital
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Onawa, Iowa, Verenigde Staten, 51040
- Burgess Health Center
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Ottumwa, Iowa, Verenigde Staten, 52501
- Ottumwa Regional Health Center Cancer Center
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Sioux City, Iowa, Verenigde Staten, 51101-1733
- Siouxland Regional Cancer Center
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Sioux City, Iowa, Verenigde Staten, 51104
- St. Luke's Regional Medical Center
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Sioux City, Iowa, Verenigde Staten, 51104
- Mercy Medical Center - Sioux City
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Sioux City, Iowa, Verenigde Staten, 51101
- Siouxland Hematology-Oncology Associates
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West Des Moines, Iowa, Verenigde Staten, 50266
- Medical Oncology and Hematology Associates - West Des Moines
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Kansas
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Chanute, Kansas, Verenigde Staten, 66720
- Cancer Center of Kansas - Chanute
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Dodge City, Kansas, Verenigde Staten, 67801
- Cancer Center of Kansas - Dodge City
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El Dorado, Kansas, Verenigde Staten, 67042
- Cancer Center of Kansas, P.A. - El Dorado
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Kingman, Kansas, Verenigde Staten, 67068
- Cancer Center of Kansas - Kingman
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Liberal, Kansas, Verenigde Staten, 67901
- Southwest Medical Center
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Newton, Kansas, Verenigde Staten, 67114
- Cancer Center of Kansas - Newton
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Parsons, Kansas, Verenigde Staten, 67357
- Cancer Center of Kansas, P.A. - Parsons
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Pratt, Kansas, Verenigde Staten, 67124
- Pratt Cancer Center of Kansas
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Salina, Kansas, Verenigde Staten, 67042
- Cancer Center of Kansas - Salina
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Wellington, Kansas, Verenigde Staten, 67152
- Cancer Center of Kansas - Wellington
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Wichita, Kansas, Verenigde Staten, 67214
- CCOP - Wichita
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Wichita, Kansas, Verenigde Staten, 67214
- Via Christi Cancer Center at Via Christi Regional Medical Center
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Wichita, Kansas, Verenigde Staten, 67203
- Associates In Womens Health
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Wichita, Kansas, Verenigde Staten, 67208
- Cancer Center of Kansas, P.A.
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Wichita, Kansas, Verenigde Staten, 67214
- Cancer Center of Kansas, P.A. - Wichita
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Winfield, Kansas, Verenigde Staten, 67156
- Cancer Center of Kansas - Winfield
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Michigan
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Adrian, Michigan, Verenigde Staten, 49221
- Hickman Cancer Center at Bixby Medical Center
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Escanaba, Michigan, Verenigde Staten, 49431
- Green Bay Oncology, Limited - Escanaba
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Iron Mountain, Michigan, Verenigde Staten, 49801
- Green Bay Oncology, Limited - Iron Mountain
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Lambertville, Michigan, Verenigde Staten, 48144
- Haematology-Oncology Associates of Ohio and Michigan, P.C.
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Monroe, Michigan, Verenigde Staten, 48162
- Community Cancer Center of Monroe
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Monroe, Michigan, Verenigde Staten, 48162
- Mercy Memorial Hospital System
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Minnesota
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Bemidji, Minnesota, Verenigde Staten, 56601
- MeritCare Clinic - Bemidji
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Brainerd, Minnesota, Verenigde Staten, 56401
- Brainerd Medical Center
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Brainerd, Minnesota, Verenigde Staten, 56401
- St. Joseph's Medical Center
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Burnsville, Minnesota, Verenigde Staten, 55337
- Fairview Ridges Hospital
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Coon Rapids, Minnesota, Verenigde Staten, 55433
- Mercy and Unity Cancer Center at Mercy Hospital
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Duluth, Minnesota, Verenigde Staten, 55805
- CCOP - Duluth
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Duluth, Minnesota, Verenigde Staten, 55805
- St. Mary's - Duluth Clinic Cancer Center
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Duluth, Minnesota, Verenigde Staten, 55805
- Miller-Dwan Medical Center
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Edina, Minnesota, Verenigde Staten, 55435
- Fairview Southdale Hospital
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Fridley, Minnesota, Verenigde Staten, 55432
- Mercy and Unity Cancer Center at Unity Hospital
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Minneapolis, Minnesota, Verenigde Staten, 55403
- Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
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Montevideo, Minnesota, Verenigde Staten, 56265
- Chippewa County - Montevideo Hospital
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Robbinsdale, Minnesota, Verenigde Staten, 55422
- Hubert H. Humphrey Cancer Center at North Memorial Medical Center
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Rochester, Minnesota, Verenigde Staten, 55905
- Mayo Clinic Cancer Center
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Saint Cloud, Minnesota, Verenigde Staten, 56303
- St. Cloud Hospital
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Saint Louis Park, Minnesota, Verenigde Staten, 55416
- CCOP - Metro-Minnesota
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St. Cloud, Minnesota, Verenigde Staten, 56303
- CentraCare Clinic - River Campus
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St. Cloud, Minnesota, Verenigde Staten, 56303
- Adult and Pediatric Urology, P.L.L.P.
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St. Louis Park, Minnesota, Verenigde Staten, 55416
- Park Nicollet Health Services
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St. Paul, Minnesota, Verenigde Staten, 55102
- United Hospital
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Waconia, Minnesota, Verenigde Staten, 55387
- Ridgeview Medical Center
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Montana
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Billings, Montana, Verenigde Staten, 59101
- CCOP - Montana Cancer Consortium
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Billings, Montana, Verenigde Staten, 59101
- Northern Rockies Radiation Oncology Center
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Billings, Montana, Verenigde Staten, 59101
- Deaconess Billings Clinic - Downtown
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Billings, Montana, Verenigde Staten, 59101
- St. Vincent Healthcare
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Billings, Montana, Verenigde Staten, 59107
- Deaconess Billings Clinic Cancer Center
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Bozeman, Montana, Verenigde Staten, 59715
- Bozeman Deaconess Hospital
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Butte, Montana, Verenigde Staten, 59701
- St. James Community Hospital
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Great Falls, Montana, Verenigde Staten, 59405
- Great Falls Clinic
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Great Falls, Montana, Verenigde Staten, 59405
- Sletten Regional Cancer Institute
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Helena, Montana, Verenigde Staten, 59601
- St. Peter's Hospital
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Kalispell, Montana, Verenigde Staten, 59901
- Kalispell Regional Medical Center
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Miles City, Montana, Verenigde Staten, 59301
- Eastern Montana Cancer Center
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Missoula, Montana, Verenigde Staten, 59801
- Community Medical Center
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Missoula, Montana, Verenigde Staten, 59802
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
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Nebraska
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Fremont, Nebraska, Verenigde Staten, 68025
- Fremont Area Medical Center
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Omaha, Nebraska, Verenigde Staten, 68131
- Creighton University Medical Center
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Omaha, Nebraska, Verenigde Staten, 68106
- CCOP - Missouri Valley Cancer Consortium
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Omaha, Nebraska, Verenigde Staten, 68122
- Immanuel Medical Center
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Omaha, Nebraska, Verenigde Staten, 68124
- Bergan Mercy Medical Center
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Papillion, Nebraska, Verenigde Staten, 68046
- Midlands Cancer Center at Midlands Community Hospital
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North Carolina
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Rutherfordton, North Carolina, Verenigde Staten, 28139
- Rutherford Hospital
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North Dakota
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Bismarck, North Dakota, Verenigde Staten, 58501
- Mid Dakota Clinic, P.C.
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Bismarck, North Dakota, Verenigde Staten, 58501
- Bismarck Cancer Center
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Bismarck, North Dakota, Verenigde Staten, 58501
- Cancer Care Center at Medcenter One Hospital
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Bismarck, North Dakota, Verenigde Staten, 58501
- St. Alexius Medical Center
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Fargo, North Dakota, Verenigde Staten, 58122
- CCOP - MeritCare Hospital
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Fargo, North Dakota, Verenigde Staten, 58122
- MeritCare Medical Group
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Ohio
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Bowling Green, Ohio, Verenigde Staten, 43402
- Wood County Oncology Center
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Dayton, Ohio, Verenigde Staten, 45428
- Veterans Affairs Medical Center - Dayton
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Dayton, Ohio, Verenigde Staten, 45405
- Grandview Hospital
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Dayton, Ohio, Verenigde Staten, 45406
- Good Samaritan Hospital
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Dayton, Ohio, Verenigde Staten, 45409
- David L. Rike Cancer Center at Miami Valley Hospital
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Dayton, Ohio, Verenigde Staten, 45415
- Samaritan North Cancer Care Center
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Dayton, Ohio, Verenigde Staten, 45429
- CCOP - Dayton
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Findlay, Ohio, Verenigde Staten, 45840
- Blanchard Valley Medical Associates
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Fremont, Ohio, Verenigde Staten, 43420
- Fremont Memorial Hospital
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Kenton, Ohio, Verenigde Staten, 43326
- Kenton Oncology, Incorporated
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Kettering, Ohio, Verenigde Staten, 45429
- Charles F. Kettering Memorial Hospital
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Lima, Ohio, Verenigde Staten, 45804
- Lima Memorial Hospital
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Maumee, Ohio, Verenigde Staten, 43537
- Northwest Ohio Oncology Center
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Maumee, Ohio, Verenigde Staten, 43537
- St. Luke's Hospital
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Middletown, Ohio, Verenigde Staten, 45044
- Middletown Regional Hospital
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Oregon, Ohio, Verenigde Staten, 43616
- St. Charles Mercy Hospital
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Oregon, Ohio, Verenigde Staten, 43616
- Toledo Clinic - Oregon
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Sandusky, Ohio, Verenigde Staten, 44870
- Firelands Regional Medical Center
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Sandusky, Ohio, Verenigde Staten, 44870
- North Coast Cancer Care, Incorporated
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Sylvania, Ohio, Verenigde Staten, 43560
- Promedica Cancer Center at Flower Hospital
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Tiffin, Ohio, Verenigde Staten, 44883
- Mercy Hospital of Tiffin
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Toledo, Ohio, Verenigde Staten, 43608
- St. Vincent Mercy Medical Center
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Toledo, Ohio, Verenigde Staten, 43606
- Toledo Hospital
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Toledo, Ohio, Verenigde Staten, 43623
- CCOP - Toledo Community Hospital
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Toledo, Ohio, Verenigde Staten, 43614
- Medical College of Ohio Cancer Institute
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Toledo, Ohio, Verenigde Staten, 43623
- Toledo Surgical Specialists
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Toledo, Ohio, Verenigde Staten, 43623
- Toledo Clinic, Incorporated
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Troy, Ohio, Verenigde Staten, 45373
- UVMC Cancer Care Center at Upper Valley Medical Center
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Wauseon, Ohio, Verenigde Staten, 43567
- Fulton County Health Center
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Wright-Patterson Afb, Ohio, Verenigde Staten, 45433-5529
- United States Air Force Medical Center Wright-Patterson
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Xenia, Ohio, Verenigde Staten, 45385
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
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Oklahoma
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Tulsa, Oklahoma, Verenigde Staten, 74136
- Natalie Warren Bryant Cancer Center at St. Francis Hospital
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Pennsylvania
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Danville, Pennsylvania, Verenigde Staten, 17822-2001
- Geisinger Medical Center
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State College, Pennsylvania, Verenigde Staten, 16801
- Geisinger Medical Group
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Wilkes-Barre, Pennsylvania, Verenigde Staten, 18711
- Geisinger Wyoming Valley Medical Center
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South Carolina
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Anderson, South Carolina, Verenigde Staten, 29621
- Rose Ramer Cancer Clinic at Anderson Area Medical Center
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Spartanburg, South Carolina, Verenigde Staten, 29303
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
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Spartanburg, South Carolina, Verenigde Staten, 29304
- CCOP - Upstate Carolina
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South Dakota
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Sioux Falls, South Dakota, Verenigde Staten, 57105
- Medical X-Ray Center
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Sioux Falls, South Dakota, Verenigde Staten, 57104
- Sioux Valley Hospital and University of South Dakota Medical Center
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Sioux Falls, South Dakota, Verenigde Staten, 57105
- Avera McKennan Hospital and University Health Center
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Wisconsin
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Eau Claire, Wisconsin, Verenigde Staten, 54702
- Luther Mildelfort Hospital
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Eau Claire, Wisconsin, Verenigde Staten, 54702
- Midelfort Clinic - Luther
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Green Bay, Wisconsin, Verenigde Staten, 54303
- Green Bay Oncology, Limited at St. Mary's Hospital
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Green Bay, Wisconsin, Verenigde Staten, 54301-3526
- Green Bay Oncology, Limited at St. Vincent Hospital
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Green Bay, Wisconsin, Verenigde Staten, 54301
- St. Vincent Hospital
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Green Bay, Wisconsin, Verenigde Staten, 54303
- St. Mary's Hospital Medical Center
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La Crosse, Wisconsin, Verenigde Staten, 54601
- Franciscan Skemp Healthcare
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Oconto Falls, Wisconsin, Verenigde Staten, 54154
- Green Bay Oncology, Limited - Oconto Falls
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Sturgeon Bay, Wisconsin, Verenigde Staten, 54235
- Green Bay Oncology, Limited - Sturgeon Bay
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Wyoming
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Sheridan, Wyoming, Verenigde Staten, 82801
- Welch Cancer Center
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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. |
|
|
Actieve vergelijker: 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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Assessment of weight
Tijdsspanne: Up to 5 years
|
Up to 5 years
|
|
Rate of weight change
Tijdsspanne: Up to 5 years
|
Up to 5 years
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Algemeen overleven
Tijdsspanne: Tot 5 jaar
|
Tot 5 jaar
|
|
Kwaliteit van het leven
Tijdsspanne: Tot 5 jaar
|
Tot 5 jaar
|
|
Incidentie van behandelingsgerelateerde toxiciteit
Tijdsspanne: Tot 5 jaar
|
Tot 5 jaar
|
|
Cancer-related fatigue as measured by the Brief Fatigue Inventory
Tijdsspanne: Up to 5 years
|
Up to 5 years
|
|
Time-to-weight decline
Tijdsspanne: Up to 5 years
|
Up to 5 years
|
|
Appetite
Tijdsspanne: Up to 5 years
|
Up to 5 years
|
|
Lean tissue changes
Tijdsspanne: Up to 5 years
|
Up to 5 years
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Medewerkers
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 oktober 2002
Primaire voltooiing (Werkelijk)
1 februari 2006
Studie voltooiing (Werkelijk)
1 oktober 2008
Studieregistratiedata
Eerst ingediend
8 juli 2002
Eerst ingediend dat voldeed aan de QC-criteria
26 januari 2003
Eerst geplaatst (Schatting)
27 januari 2003
Updates van studierecords
Laatste update geplaatst (Schatting)
7 december 2016
Laatste update ingediend die voldeed aan QC-criteria
5 december 2016
Laatst geverifieerd
1 december 2016
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Metabole ziekten
- Ziekten van de luchtwegen
- Neoplasmata
- Longziekten
- Neoplasmata per site
- Tekenen en symptomen, spijsvertering
- Voedingsstoornissen
- Lichaamsgewicht
- Neoplasmata van de luchtwegen
- Thoracale neoplasmata
- Carcinoom, bronchogeen
- Bronchiale neoplasmata
- Veranderingen in lichaamsgewicht
- Vermagering
- Gewichtsverlies
- Anorexia
- Vermoeidheid
- Longneoplasmata
- Carcinoom, niet-kleincellige long
- Verspillingssyndroom
- Cachexie
- Moleculaire mechanismen van farmacologische werking
- Antireumatische middelen
- Antineoplastische middelen
- Tubuline-modulatoren
- Antimitotische middelen
- Mitose modulatoren
- Gastro-intestinale middelen
- Dermatologische middelen
- Docetaxel
- Infliximab
Andere studie-ID-nummers
- NCCTG-N01C9
- NCI-2012-02472 (Register-ID: CTRP (Clinical Trials Reporting System))
- NCI-P02-0226
- CDR0000069417 (Register-ID: PDQ (Physician Data Query))
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .