- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00040885
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)
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)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
-
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Arizona
-
Scottsdale, Arizona, Estados Unidos, 85259
- CCOP - Mayo Clinic Scottsdale Oncology Program
-
-
Colorado
-
Aurora, Colorado, Estados Unidos, 80012
- Aurora Presbyterian Hospital
-
Boulder, Colorado, Estados Unidos, 80301
- Boulder Community Hospital
-
Colorado Springs, Colorado, Estados Unidos, 80933
- Penrose Cancer Center at Penrose Hospital
-
Denver, Colorado, Estados Unidos, 80210
- Porter Adventist Hospital
-
Denver, Colorado, Estados Unidos, 80220
- Rose Medical Center
-
Denver, Colorado, Estados Unidos, 80218
- Presbyterian - St. Luke's Medical Center
-
Denver, Colorado, Estados Unidos, 80218
- St. Joseph Hospital
-
Denver, Colorado, Estados Unidos, 80224-2522
- CCOP - Colorado Cancer Research Program, Incorporated
-
Englewood, Colorado, Estados Unidos, 80110
- Swedish Medical Center
-
Lone Tree, Colorado, Estados Unidos, 80124
- Sky Ridge Medical Center
-
Longmont, Colorado, Estados Unidos, 80502
- Hope Cancer Care Center at Longmont United Hospital
-
Pueblo, Colorado, Estados Unidos, 81004
- St. Mary-Corwin Regional Medical Center
-
Thorton, Colorado, Estados Unidos, 80229
- North Suburban Medical Center
-
-
Florida
-
Jacksonville, Florida, Estados Unidos, 32224-9980
- Mayo Clinic - Jacksonville
-
-
Illinois
-
Aurora, Illinois, Estados Unidos, 60507
- Rush-Copley Cancer Care Center
-
Bloomington, Illinois, Estados Unidos, 61701
- St. Joseph Medical Center
-
Canton, Illinois, Estados Unidos, 61520
- Graham Hospital
-
Carthage, Illinois, Estados Unidos, 62321
- Memorial Hospital
-
Eureka, Illinois, Estados Unidos, 61530
- Eureka Community Hospital
-
Galesburg, Illinois, Estados Unidos, 61401
- Galesburg Cottage Hospital
-
Galesburg, Illinois, Estados Unidos, 61401
- Galesburg Clinic
-
Galesburg, Illinois, Estados Unidos, 61401
- InterCommunity Cancer Center of Western Illinois
-
Havana, Illinois, Estados Unidos, 62644
- Mason District Hospital
-
Hopedale, Illinois, Estados Unidos, 61747
- Hopedale Medical Complex
-
Joliet, Illinois, Estados Unidos, 60435
- Joliet Oncology Hematology Associates, Limited - West
-
Kewanee, Illinois, Estados Unidos, 61443
- Kewanee Hospital
-
Macomb, Illinois, Estados Unidos, 61455
- Mcdonough District Hospital
-
Normal, Illinois, Estados Unidos, 61761
- Bromenn Regional Medical Center
-
Normal, Illinois, Estados Unidos, 61761
- Community Cancer Center
-
Ottawa, Illinois, Estados Unidos, 61350
- Community Hospital of Ottawa
-
Ottawa, Illinois, Estados Unidos, 61350
- Oncology Hematology Associates of Central Illinois - Ottawa
-
Pekin, Illinois, Estados Unidos, 61554
- Cancer Treatment Center at Pekin Hospital
-
Peoria, Illinois, Estados Unidos, 61614
- Proctor Hospital
-
Peoria, Illinois, Estados Unidos, 61603
- Methodist Medical Center of Illinois
-
Peoria, Illinois, Estados Unidos, 61637
- OSF St. Francis Medical Center
-
Peoria, Illinois, Estados Unidos, 61615
- CCOP - Illinois Oncology Research Association
-
Peoria, Illinois, Estados Unidos, 61615
- Oncology/Hematology Associates of Central Illinois, P.C.
-
Peru, Illinois, Estados Unidos, 61354
- Illinois Valley Community Hospital
-
Princeton, Illinois, Estados Unidos, 61356
- Perry Memorial Hospital
-
Spring Valley, Illinois, Estados Unidos, 61362
- St. Margaret's Hospital
-
Spring Valley, Illinois, Estados Unidos, 61362
- Valley Cancer Center
-
Urbana, Illinois, Estados Unidos, 61801
- Carle Cancer Center at Carle Foundation Hospital
-
Urbana, Illinois, Estados Unidos, 61801
- CCOP - Carle Cancer Center
-
-
Indiana
-
Beech Grove, Indiana, Estados Unidos, 46107
- St. Francis Hospital and Health Centers
-
Michigan City, Indiana, Estados Unidos, 46360
- Saint Anthony Memorial Health Centers
-
-
Iowa
-
Carroll, Iowa, Estados Unidos, 51401
- Saint Anthony Regional Hospital
-
Cedar Rapids, Iowa, Estados Unidos, 52402
- St. Luke's Hospital
-
Cedar Rapids, Iowa, Estados Unidos, 52403
- Cedar Rapids Oncology Associates
-
Cedar Rapids, Iowa, Estados Unidos, 52403
- Mercy Cancer Center at Mercy Medical Center
-
Council Bluffs, Iowa, Estados Unidos, 51503
- Alegent Health Mercy Hospital
-
Des Moines, Iowa, Estados Unidos, 50309
- CCOP - Iowa Oncology Research Association
-
Des Moines, Iowa, Estados Unidos, 50309
- John Stoddard Cancer Center at Iowa Methodist Medical Center
-
Des Moines, Iowa, Estados Unidos, 50309
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
-
Des Moines, Iowa, Estados Unidos, 50314
- Medical Oncology and Hematology Associates at Mercy Cancer Center
-
Des Moines, Iowa, Estados Unidos, 50314
- Mercy Cancer Center at Mercy Medical Center - Des Moines
-
Des Moines, Iowa, Estados Unidos, 50316
- John Stoddard Cancer Center at Iowa Lutheran Hospital
-
Des Moines, Iowa, Estados Unidos, 50307
- Mercy Capitol Hospital
-
Mason City, Iowa, Estados Unidos, 50401
- Mercy Cancer Center at Mercy Medical Center - North Iowa
-
Missouri Valley, Iowa, Estados Unidos, 51555
- Alegent Health Community Memorial Hospital
-
Onawa, Iowa, Estados Unidos, 51040
- Burgess Health Center
-
Ottumwa, Iowa, Estados Unidos, 52501
- Ottumwa Regional Health Center Cancer Center
-
Sioux City, Iowa, Estados Unidos, 51101-1733
- Siouxland Regional Cancer Center
-
Sioux City, Iowa, Estados Unidos, 51104
- St. Luke's Regional Medical Center
-
Sioux City, Iowa, Estados Unidos, 51104
- Mercy Medical Center - Sioux City
-
Sioux City, Iowa, Estados Unidos, 51101
- Siouxland Hematology-Oncology Associates
-
West Des Moines, Iowa, Estados Unidos, 50266
- Medical Oncology and Hematology Associates - West Des Moines
-
-
Kansas
-
Chanute, Kansas, Estados Unidos, 66720
- Cancer Center of Kansas - Chanute
-
Dodge City, Kansas, Estados Unidos, 67801
- Cancer Center of Kansas - Dodge City
-
El Dorado, Kansas, Estados Unidos, 67042
- Cancer Center of Kansas, P.A. - El Dorado
-
Kingman, Kansas, Estados Unidos, 67068
- Cancer Center of Kansas - Kingman
-
Liberal, Kansas, Estados Unidos, 67901
- Southwest Medical Center
-
Newton, Kansas, Estados Unidos, 67114
- Cancer Center of Kansas - Newton
-
Parsons, Kansas, Estados Unidos, 67357
- Cancer Center of Kansas, P.A. - Parsons
-
Pratt, Kansas, Estados Unidos, 67124
- Pratt Cancer Center of Kansas
-
Salina, Kansas, Estados Unidos, 67042
- Cancer Center of Kansas - Salina
-
Wellington, Kansas, Estados Unidos, 67152
- Cancer Center of Kansas - Wellington
-
Wichita, Kansas, Estados Unidos, 67214
- CCOP - Wichita
-
Wichita, Kansas, Estados Unidos, 67214
- Via Christi Cancer Center at Via Christi Regional Medical Center
-
Wichita, Kansas, Estados Unidos, 67203
- Associates In Womens Health
-
Wichita, Kansas, Estados Unidos, 67208
- Cancer Center of Kansas, P.A.
-
Wichita, Kansas, Estados Unidos, 67214
- Cancer Center of Kansas, P.A. - Wichita
-
Winfield, Kansas, Estados Unidos, 67156
- Cancer Center of Kansas - Winfield
-
-
Michigan
-
Adrian, Michigan, Estados Unidos, 49221
- Hickman Cancer Center at Bixby Medical Center
-
Escanaba, Michigan, Estados Unidos, 49431
- Green Bay Oncology, Limited - Escanaba
-
Iron Mountain, Michigan, Estados Unidos, 49801
- Green Bay Oncology, Limited - Iron Mountain
-
Lambertville, Michigan, Estados Unidos, 48144
- Haematology-Oncology Associates of Ohio and Michigan, P.C.
-
Monroe, Michigan, Estados Unidos, 48162
- Community Cancer Center of Monroe
-
Monroe, Michigan, Estados Unidos, 48162
- Mercy Memorial Hospital System
-
-
Minnesota
-
Bemidji, Minnesota, Estados Unidos, 56601
- MeritCare Clinic - Bemidji
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Brainerd, Minnesota, Estados Unidos, 56401
- Brainerd Medical Center
-
Brainerd, Minnesota, Estados Unidos, 56401
- St. Joseph's Medical Center
-
Burnsville, Minnesota, Estados Unidos, 55337
- Fairview Ridges Hospital
-
Coon Rapids, Minnesota, Estados Unidos, 55433
- Mercy and Unity Cancer Center at Mercy Hospital
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Duluth, Minnesota, Estados Unidos, 55805
- CCOP - Duluth
-
Duluth, Minnesota, Estados Unidos, 55805
- St. Mary's - Duluth Clinic Cancer Center
-
Duluth, Minnesota, Estados Unidos, 55805
- Miller-Dwan Medical Center
-
Edina, Minnesota, Estados Unidos, 55435
- Fairview Southdale Hospital
-
Fridley, Minnesota, Estados Unidos, 55432
- Mercy and Unity Cancer Center at Unity Hospital
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Minneapolis, Minnesota, Estados Unidos, 55403
- Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
-
Montevideo, Minnesota, Estados Unidos, 56265
- Chippewa County - Montevideo Hospital
-
Robbinsdale, Minnesota, Estados Unidos, 55422
- Hubert H. Humphrey Cancer Center at North Memorial Medical Center
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Rochester, Minnesota, Estados Unidos, 55905
- Mayo Clinic Cancer Center
-
Saint Cloud, Minnesota, Estados Unidos, 56303
- St. Cloud Hospital
-
Saint Louis Park, Minnesota, Estados Unidos, 55416
- CCOP - Metro-Minnesota
-
St. Cloud, Minnesota, Estados Unidos, 56303
- CentraCare Clinic - River Campus
-
St. Cloud, Minnesota, Estados Unidos, 56303
- Adult and Pediatric Urology, P.L.L.P.
-
St. Louis Park, Minnesota, Estados Unidos, 55416
- Park Nicollet Health Services
-
St. Paul, Minnesota, Estados Unidos, 55102
- United Hospital
-
Waconia, Minnesota, Estados Unidos, 55387
- Ridgeview Medical Center
-
-
Montana
-
Billings, Montana, Estados Unidos, 59101
- CCOP - Montana Cancer Consortium
-
Billings, Montana, Estados Unidos, 59101
- Northern Rockies Radiation Oncology Center
-
Billings, Montana, Estados Unidos, 59101
- Deaconess Billings Clinic - Downtown
-
Billings, Montana, Estados Unidos, 59101
- St. Vincent Healthcare
-
Billings, Montana, Estados Unidos, 59107
- Deaconess Billings Clinic Cancer Center
-
Bozeman, Montana, Estados Unidos, 59715
- Bozeman Deaconess Hospital
-
Butte, Montana, Estados Unidos, 59701
- St. James Community Hospital
-
Great Falls, Montana, Estados Unidos, 59405
- Great Falls Clinic
-
Great Falls, Montana, Estados Unidos, 59405
- Sletten Regional Cancer Institute
-
Helena, Montana, Estados Unidos, 59601
- St. Peter's Hospital
-
Kalispell, Montana, Estados Unidos, 59901
- Kalispell Regional Medical Center
-
Miles City, Montana, Estados Unidos, 59301
- Eastern Montana Cancer Center
-
Missoula, Montana, Estados Unidos, 59801
- Community Medical Center
-
Missoula, Montana, Estados Unidos, 59802
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
-
-
Nebraska
-
Fremont, Nebraska, Estados Unidos, 68025
- Fremont Area Medical Center
-
Omaha, Nebraska, Estados Unidos, 68131
- Creighton University Medical Center
-
Omaha, Nebraska, Estados Unidos, 68106
- CCOP - Missouri Valley Cancer Consortium
-
Omaha, Nebraska, Estados Unidos, 68122
- Immanuel Medical Center
-
Omaha, Nebraska, Estados Unidos, 68124
- Bergan Mercy Medical Center
-
Papillion, Nebraska, Estados Unidos, 68046
- Midlands Cancer Center at Midlands Community Hospital
-
-
North Carolina
-
Rutherfordton, North Carolina, Estados Unidos, 28139
- Rutherford Hospital
-
-
North Dakota
-
Bismarck, North Dakota, Estados Unidos, 58501
- Mid Dakota Clinic, P.C.
-
Bismarck, North Dakota, Estados Unidos, 58501
- Bismarck Cancer Center
-
Bismarck, North Dakota, Estados Unidos, 58501
- Cancer Care Center at Medcenter One Hospital
-
Bismarck, North Dakota, Estados Unidos, 58501
- St. Alexius Medical Center
-
Fargo, North Dakota, Estados Unidos, 58122
- CCOP - MeritCare Hospital
-
Fargo, North Dakota, Estados Unidos, 58122
- MeritCare Medical Group
-
-
Ohio
-
Bowling Green, Ohio, Estados Unidos, 43402
- Wood County Oncology Center
-
Dayton, Ohio, Estados Unidos, 45428
- Veterans Affairs Medical Center - Dayton
-
Dayton, Ohio, Estados Unidos, 45405
- Grandview Hospital
-
Dayton, Ohio, Estados Unidos, 45406
- Good Samaritan Hospital
-
Dayton, Ohio, Estados Unidos, 45409
- David L. Rike Cancer Center at Miami Valley Hospital
-
Dayton, Ohio, Estados Unidos, 45415
- Samaritan North Cancer Care Center
-
Dayton, Ohio, Estados Unidos, 45429
- CCOP - Dayton
-
Findlay, Ohio, Estados Unidos, 45840
- Blanchard Valley Medical Associates
-
Fremont, Ohio, Estados Unidos, 43420
- Fremont Memorial Hospital
-
Kenton, Ohio, Estados Unidos, 43326
- Kenton Oncology, Incorporated
-
Kettering, Ohio, Estados Unidos, 45429
- Charles F. Kettering Memorial Hospital
-
Lima, Ohio, Estados Unidos, 45804
- Lima Memorial Hospital
-
Maumee, Ohio, Estados Unidos, 43537
- Northwest Ohio Oncology Center
-
Maumee, Ohio, Estados Unidos, 43537
- St. Luke's Hospital
-
Middletown, Ohio, Estados Unidos, 45044
- Middletown Regional Hospital
-
Oregon, Ohio, Estados Unidos, 43616
- St. Charles Mercy Hospital
-
Oregon, Ohio, Estados Unidos, 43616
- Toledo Clinic - Oregon
-
Sandusky, Ohio, Estados Unidos, 44870
- Firelands Regional Medical Center
-
Sandusky, Ohio, Estados Unidos, 44870
- North Coast Cancer Care, Incorporated
-
Sylvania, Ohio, Estados Unidos, 43560
- Promedica Cancer Center at Flower Hospital
-
Tiffin, Ohio, Estados Unidos, 44883
- Mercy Hospital of Tiffin
-
Toledo, Ohio, Estados Unidos, 43608
- St. Vincent Mercy Medical Center
-
Toledo, Ohio, Estados Unidos, 43606
- Toledo Hospital
-
Toledo, Ohio, Estados Unidos, 43623
- CCOP - Toledo Community Hospital
-
Toledo, Ohio, Estados Unidos, 43614
- Medical College of Ohio Cancer Institute
-
Toledo, Ohio, Estados Unidos, 43623
- Toledo Surgical Specialists
-
Toledo, Ohio, Estados Unidos, 43623
- Toledo Clinic, Incorporated
-
Troy, Ohio, Estados Unidos, 45373
- UVMC Cancer Care Center at Upper Valley Medical Center
-
Wauseon, Ohio, Estados Unidos, 43567
- Fulton County Health Center
-
Wright-Patterson Afb, Ohio, Estados Unidos, 45433-5529
- United States Air Force Medical Center Wright-Patterson
-
Xenia, Ohio, Estados Unidos, 45385
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
-
-
Oklahoma
-
Tulsa, Oklahoma, Estados Unidos, 74136
- Natalie Warren Bryant Cancer Center at St. Francis Hospital
-
-
Pennsylvania
-
Danville, Pennsylvania, Estados Unidos, 17822-2001
- Geisinger Medical Center
-
State College, Pennsylvania, Estados Unidos, 16801
- Geisinger Medical Group
-
Wilkes-Barre, Pennsylvania, Estados Unidos, 18711
- Geisinger Wyoming Valley Medical Center
-
-
South Carolina
-
Anderson, South Carolina, Estados Unidos, 29621
- Rose Ramer Cancer Clinic at Anderson Area Medical Center
-
Spartanburg, South Carolina, Estados Unidos, 29303
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
-
Spartanburg, South Carolina, Estados Unidos, 29304
- CCOP - Upstate Carolina
-
-
South Dakota
-
Sioux Falls, South Dakota, Estados Unidos, 57105
- Medical X-Ray Center
-
Sioux Falls, South Dakota, Estados Unidos, 57104
- Sioux Valley Hospital and University of South Dakota Medical Center
-
Sioux Falls, South Dakota, Estados Unidos, 57105
- Avera McKennan Hospital and University Health Center
-
-
Wisconsin
-
Eau Claire, Wisconsin, Estados Unidos, 54702
- Luther Mildelfort Hospital
-
Eau Claire, Wisconsin, Estados Unidos, 54702
- Midelfort Clinic - Luther
-
Green Bay, Wisconsin, Estados Unidos, 54303
- Green Bay Oncology, Limited at St. Mary's Hospital
-
Green Bay, Wisconsin, Estados Unidos, 54301-3526
- Green Bay Oncology, Limited at St. Vincent Hospital
-
Green Bay, Wisconsin, Estados Unidos, 54301
- St. Vincent Hospital
-
Green Bay, Wisconsin, Estados Unidos, 54303
- St. Mary's Hospital Medical Center
-
La Crosse, Wisconsin, Estados Unidos, 54601
- Franciscan Skemp Healthcare
-
Oconto Falls, Wisconsin, Estados Unidos, 54154
- Green Bay Oncology, Limited - Oconto Falls
-
Sturgeon Bay, Wisconsin, Estados Unidos, 54235
- Green Bay Oncology, Limited - Sturgeon Bay
-
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Wyoming
-
Sheridan, Wyoming, Estados Unidos, 82801
- Welch Cancer Center
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: 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. |
|
Comparador activo: 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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Assessment of weight
Periodo de tiempo: Up to 5 years
|
Up to 5 years
|
Rate of weight change
Periodo de tiempo: Up to 5 years
|
Up to 5 years
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Sobrevivencia promedio
Periodo de tiempo: Hasta 5 años
|
Hasta 5 años
|
Calidad de vida
Periodo de tiempo: Hasta 5 años
|
Hasta 5 años
|
Incidencia de toxicidad relacionada con el tratamiento
Periodo de tiempo: Hasta 5 años
|
Hasta 5 años
|
Cancer-related fatigue as measured by the Brief Fatigue Inventory
Periodo de tiempo: Up to 5 years
|
Up to 5 years
|
Time-to-weight decline
Periodo de tiempo: Up to 5 years
|
Up to 5 years
|
Appetite
Periodo de tiempo: Up to 5 years
|
Up to 5 years
|
Lean tissue changes
Periodo de tiempo: Up to 5 years
|
Up to 5 years
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades metabólicas
- Enfermedades de las vías respiratorias
- Neoplasias
- Enfermedades pulmonares
- Neoplasias por sitio
- Signos y Síntomas Digestivos
- Trastornos Nutricionales
- Peso corporal
- Neoplasias de las vías respiratorias
- Neoplasias torácicas
- Carcinoma Broncogénico
- Neoplasias Bronquiales
- Cambios en el peso corporal
- Adelgazamiento
- Pérdida de peso
- Anorexia
- Fatiga
- Neoplasias Pulmonares
- Carcinoma de pulmón de células no pequeñas
- Síndrome de desgaste
- Caquexia
- Mecanismos moleculares de acción farmacológica
- Agentes antirreumáticos
- Agentes antineoplásicos
- Moduladores de tubulina
- Agentes antimitóticos
- Moduladores de mitosis
- Agentes Gastrointestinales
- Agentes dermatológicos
- Docetaxel
- Infliximab
Otros números de identificación del estudio
- NCCTG-N01C9
- NCI-2012-02472 (Identificador de registro: CTRP (Clinical Trials Reporting System))
- NCI-P02-0226
- CDR0000069417 (Identificador de registro: PDQ (Physician Data Query))
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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