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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 dicembre 2016 aggiornato da: 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)

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Effettivo)

67

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Arizona
      • Scottsdale, Arizona, Stati Uniti, 85259
        • CCOP - Mayo Clinic Scottsdale Oncology Program
    • Colorado
      • Aurora, Colorado, Stati Uniti, 80012
        • Aurora Presbyterian Hospital
      • Boulder, Colorado, Stati Uniti, 80301
        • Boulder Community Hospital
      • Colorado Springs, Colorado, Stati Uniti, 80933
        • Penrose Cancer Center at Penrose Hospital
      • Denver, Colorado, Stati Uniti, 80210
        • Porter Adventist Hospital
      • Denver, Colorado, Stati Uniti, 80220
        • Rose Medical Center
      • Denver, Colorado, Stati Uniti, 80218
        • Presbyterian - St. Luke's Medical Center
      • Denver, Colorado, Stati Uniti, 80218
        • St. Joseph Hospital
      • Denver, Colorado, Stati Uniti, 80224-2522
        • CCOP - Colorado Cancer Research Program, Incorporated
      • Englewood, Colorado, Stati Uniti, 80110
        • Swedish Medical Center
      • Lone Tree, Colorado, Stati Uniti, 80124
        • Sky Ridge Medical Center
      • Longmont, Colorado, Stati Uniti, 80502
        • Hope Cancer Care Center at Longmont United Hospital
      • Pueblo, Colorado, Stati Uniti, 81004
        • St. Mary-Corwin Regional Medical Center
      • Thorton, Colorado, Stati Uniti, 80229
        • North Suburban Medical Center
    • Florida
      • Jacksonville, Florida, Stati Uniti, 32224-9980
        • Mayo Clinic - Jacksonville
    • Illinois
      • Aurora, Illinois, Stati Uniti, 60507
        • Rush-Copley Cancer Care Center
      • Bloomington, Illinois, Stati Uniti, 61701
        • St. Joseph Medical Center
      • Canton, Illinois, Stati Uniti, 61520
        • Graham Hospital
      • Carthage, Illinois, Stati Uniti, 62321
        • Memorial Hospital
      • Eureka, Illinois, Stati Uniti, 61530
        • Eureka Community Hospital
      • Galesburg, Illinois, Stati Uniti, 61401
        • Galesburg Cottage Hospital
      • Galesburg, Illinois, Stati Uniti, 61401
        • Galesburg Clinic
      • Galesburg, Illinois, Stati Uniti, 61401
        • InterCommunity Cancer Center of Western Illinois
      • Havana, Illinois, Stati Uniti, 62644
        • Mason District Hospital
      • Hopedale, Illinois, Stati Uniti, 61747
        • Hopedale Medical Complex
      • Joliet, Illinois, Stati Uniti, 60435
        • Joliet Oncology Hematology Associates, Limited - West
      • Kewanee, Illinois, Stati Uniti, 61443
        • Kewanee Hospital
      • Macomb, Illinois, Stati Uniti, 61455
        • Mcdonough District Hospital
      • Normal, Illinois, Stati Uniti, 61761
        • Bromenn Regional Medical Center
      • Normal, Illinois, Stati Uniti, 61761
        • Community Cancer Center
      • Ottawa, Illinois, Stati Uniti, 61350
        • Community Hospital of Ottawa
      • Ottawa, Illinois, Stati Uniti, 61350
        • Oncology Hematology Associates of Central Illinois - Ottawa
      • Pekin, Illinois, Stati Uniti, 61554
        • Cancer Treatment Center at Pekin Hospital
      • Peoria, Illinois, Stati Uniti, 61614
        • Proctor Hospital
      • Peoria, Illinois, Stati Uniti, 61603
        • Methodist Medical Center of Illinois
      • Peoria, Illinois, Stati Uniti, 61637
        • OSF St. Francis Medical Center
      • Peoria, Illinois, Stati Uniti, 61615
        • CCOP - Illinois Oncology Research Association
      • Peoria, Illinois, Stati Uniti, 61615
        • Oncology/Hematology Associates of Central Illinois, P.C.
      • Peru, Illinois, Stati Uniti, 61354
        • Illinois Valley Community Hospital
      • Princeton, Illinois, Stati Uniti, 61356
        • Perry Memorial Hospital
      • Spring Valley, Illinois, Stati Uniti, 61362
        • St. Margaret's Hospital
      • Spring Valley, Illinois, Stati Uniti, 61362
        • Valley Cancer Center
      • Urbana, Illinois, Stati Uniti, 61801
        • Carle Cancer Center at Carle Foundation Hospital
      • Urbana, Illinois, Stati Uniti, 61801
        • CCOP - Carle Cancer Center
    • Indiana
      • Beech Grove, Indiana, Stati Uniti, 46107
        • St. Francis Hospital and Health Centers
      • Michigan City, Indiana, Stati Uniti, 46360
        • Saint Anthony Memorial Health Centers
    • Iowa
      • Carroll, Iowa, Stati Uniti, 51401
        • Saint Anthony Regional Hospital
      • Cedar Rapids, Iowa, Stati Uniti, 52402
        • St. Luke's Hospital
      • Cedar Rapids, Iowa, Stati Uniti, 52403
        • Cedar Rapids Oncology Associates
      • Cedar Rapids, Iowa, Stati Uniti, 52403
        • Mercy Cancer Center at Mercy Medical Center
      • Council Bluffs, Iowa, Stati Uniti, 51503
        • Alegent Health Mercy Hospital
      • Des Moines, Iowa, Stati Uniti, 50309
        • CCOP - Iowa Oncology Research Association
      • Des Moines, Iowa, Stati Uniti, 50309
        • John Stoddard Cancer Center at Iowa Methodist Medical Center
      • Des Moines, Iowa, Stati Uniti, 50309
        • Medical Oncology and Hematology Associates at John Stoddard Cancer Center
      • Des Moines, Iowa, Stati Uniti, 50314
        • Medical Oncology and Hematology Associates at Mercy Cancer Center
      • Des Moines, Iowa, Stati Uniti, 50314
        • Mercy Cancer Center at Mercy Medical Center - Des Moines
      • Des Moines, Iowa, Stati Uniti, 50316
        • John Stoddard Cancer Center at Iowa Lutheran Hospital
      • Des Moines, Iowa, Stati Uniti, 50307
        • Mercy Capitol Hospital
      • Mason City, Iowa, Stati Uniti, 50401
        • Mercy Cancer Center at Mercy Medical Center - North Iowa
      • Missouri Valley, Iowa, Stati Uniti, 51555
        • Alegent Health Community Memorial Hospital
      • Onawa, Iowa, Stati Uniti, 51040
        • Burgess Health Center
      • Ottumwa, Iowa, Stati Uniti, 52501
        • Ottumwa Regional Health Center Cancer Center
      • Sioux City, Iowa, Stati Uniti, 51101-1733
        • Siouxland Regional Cancer Center
      • Sioux City, Iowa, Stati Uniti, 51104
        • St. Luke's Regional Medical Center
      • Sioux City, Iowa, Stati Uniti, 51104
        • Mercy Medical Center - Sioux City
      • Sioux City, Iowa, Stati Uniti, 51101
        • Siouxland Hematology-Oncology Associates
      • West Des Moines, Iowa, Stati Uniti, 50266
        • Medical Oncology and Hematology Associates - West Des Moines
    • Kansas
      • Chanute, Kansas, Stati Uniti, 66720
        • Cancer Center of Kansas - Chanute
      • Dodge City, Kansas, Stati Uniti, 67801
        • Cancer Center of Kansas - Dodge City
      • El Dorado, Kansas, Stati Uniti, 67042
        • Cancer Center of Kansas, P.A. - El Dorado
      • Kingman, Kansas, Stati Uniti, 67068
        • Cancer Center of Kansas - Kingman
      • Liberal, Kansas, Stati Uniti, 67901
        • Southwest Medical Center
      • Newton, Kansas, Stati Uniti, 67114
        • Cancer Center of Kansas - Newton
      • Parsons, Kansas, Stati Uniti, 67357
        • Cancer Center of Kansas, P.A. - Parsons
      • Pratt, Kansas, Stati Uniti, 67124
        • Pratt Cancer Center of Kansas
      • Salina, Kansas, Stati Uniti, 67042
        • Cancer Center of Kansas - Salina
      • Wellington, Kansas, Stati Uniti, 67152
        • Cancer Center of Kansas - Wellington
      • Wichita, Kansas, Stati Uniti, 67214
        • CCOP - Wichita
      • Wichita, Kansas, Stati Uniti, 67214
        • Via Christi Cancer Center at Via Christi Regional Medical Center
      • Wichita, Kansas, Stati Uniti, 67203
        • Associates In Womens Health
      • Wichita, Kansas, Stati Uniti, 67208
        • Cancer Center of Kansas, P.A.
      • Wichita, Kansas, Stati Uniti, 67214
        • Cancer Center of Kansas, P.A. - Wichita
      • Winfield, Kansas, Stati Uniti, 67156
        • Cancer Center of Kansas - Winfield
    • Michigan
      • Adrian, Michigan, Stati Uniti, 49221
        • Hickman Cancer Center at Bixby Medical Center
      • Escanaba, Michigan, Stati Uniti, 49431
        • Green Bay Oncology, Limited - Escanaba
      • Iron Mountain, Michigan, Stati Uniti, 49801
        • Green Bay Oncology, Limited - Iron Mountain
      • Lambertville, Michigan, Stati Uniti, 48144
        • Haematology-Oncology Associates of Ohio and Michigan, P.C.
      • Monroe, Michigan, Stati Uniti, 48162
        • Community Cancer Center of Monroe
      • Monroe, Michigan, Stati Uniti, 48162
        • Mercy Memorial Hospital System
    • Minnesota
      • Bemidji, Minnesota, Stati Uniti, 56601
        • MeritCare Clinic - Bemidji
      • Brainerd, Minnesota, Stati Uniti, 56401
        • Brainerd Medical Center
      • Brainerd, Minnesota, Stati Uniti, 56401
        • St. Joseph's Medical Center
      • Burnsville, Minnesota, Stati Uniti, 55337
        • Fairview Ridges Hospital
      • Coon Rapids, Minnesota, Stati Uniti, 55433
        • Mercy and Unity Cancer Center at Mercy Hospital
      • Duluth, Minnesota, Stati Uniti, 55805
        • CCOP - Duluth
      • Duluth, Minnesota, Stati Uniti, 55805
        • St. Mary's - Duluth Clinic Cancer Center
      • Duluth, Minnesota, Stati Uniti, 55805
        • Miller-Dwan Medical Center
      • Edina, Minnesota, Stati Uniti, 55435
        • Fairview Southdale Hospital
      • Fridley, Minnesota, Stati Uniti, 55432
        • Mercy and Unity Cancer Center at Unity Hospital
      • Minneapolis, Minnesota, Stati Uniti, 55403
        • Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
      • Montevideo, Minnesota, Stati Uniti, 56265
        • Chippewa County - Montevideo Hospital
      • Robbinsdale, Minnesota, Stati Uniti, 55422
        • Hubert H. Humphrey Cancer Center at North Memorial Medical Center
      • Rochester, Minnesota, Stati Uniti, 55905
        • Mayo Clinic Cancer Center
      • Saint Cloud, Minnesota, Stati Uniti, 56303
        • St. Cloud Hospital
      • Saint Louis Park, Minnesota, Stati Uniti, 55416
        • CCOP - Metro-Minnesota
      • St. Cloud, Minnesota, Stati Uniti, 56303
        • CentraCare Clinic - River Campus
      • St. Cloud, Minnesota, Stati Uniti, 56303
        • Adult and Pediatric Urology, P.L.L.P.
      • St. Louis Park, Minnesota, Stati Uniti, 55416
        • Park Nicollet Health Services
      • St. Paul, Minnesota, Stati Uniti, 55102
        • United Hospital
      • Waconia, Minnesota, Stati Uniti, 55387
        • Ridgeview Medical Center
    • Montana
      • Billings, Montana, Stati Uniti, 59101
        • CCOP - Montana Cancer Consortium
      • Billings, Montana, Stati Uniti, 59101
        • Northern Rockies Radiation Oncology Center
      • Billings, Montana, Stati Uniti, 59101
        • Deaconess Billings Clinic - Downtown
      • Billings, Montana, Stati Uniti, 59101
        • St. Vincent Healthcare
      • Billings, Montana, Stati Uniti, 59107
        • Deaconess Billings Clinic Cancer Center
      • Bozeman, Montana, Stati Uniti, 59715
        • Bozeman Deaconess Hospital
      • Butte, Montana, Stati Uniti, 59701
        • St. James Community Hospital
      • Great Falls, Montana, Stati Uniti, 59405
        • Great Falls Clinic
      • Great Falls, Montana, Stati Uniti, 59405
        • Sletten Regional Cancer Institute
      • Helena, Montana, Stati Uniti, 59601
        • St. Peter's Hospital
      • Kalispell, Montana, Stati Uniti, 59901
        • Kalispell Regional Medical Center
      • Miles City, Montana, Stati Uniti, 59301
        • Eastern Montana Cancer Center
      • Missoula, Montana, Stati Uniti, 59801
        • Community Medical Center
      • Missoula, Montana, Stati Uniti, 59802
        • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
    • Nebraska
      • Fremont, Nebraska, Stati Uniti, 68025
        • Fremont Area Medical Center
      • Omaha, Nebraska, Stati Uniti, 68131
        • Creighton University Medical Center
      • Omaha, Nebraska, Stati Uniti, 68106
        • CCOP - Missouri Valley Cancer Consortium
      • Omaha, Nebraska, Stati Uniti, 68122
        • Immanuel Medical Center
      • Omaha, Nebraska, Stati Uniti, 68124
        • Bergan Mercy Medical Center
      • Papillion, Nebraska, Stati Uniti, 68046
        • Midlands Cancer Center at Midlands Community Hospital
    • North Carolina
      • Rutherfordton, North Carolina, Stati Uniti, 28139
        • Rutherford Hospital
    • North Dakota
      • Bismarck, North Dakota, Stati Uniti, 58501
        • Mid Dakota Clinic, P.C.
      • Bismarck, North Dakota, Stati Uniti, 58501
        • Bismarck Cancer Center
      • Bismarck, North Dakota, Stati Uniti, 58501
        • Cancer Care Center at Medcenter One Hospital
      • Bismarck, North Dakota, Stati Uniti, 58501
        • St. Alexius Medical Center
      • Fargo, North Dakota, Stati Uniti, 58122
        • CCOP - MeritCare Hospital
      • Fargo, North Dakota, Stati Uniti, 58122
        • MeritCare Medical Group
    • Ohio
      • Bowling Green, Ohio, Stati Uniti, 43402
        • Wood County Oncology Center
      • Dayton, Ohio, Stati Uniti, 45428
        • Veterans Affairs Medical Center - Dayton
      • Dayton, Ohio, Stati Uniti, 45405
        • Grandview Hospital
      • Dayton, Ohio, Stati Uniti, 45406
        • Good Samaritan Hospital
      • Dayton, Ohio, Stati Uniti, 45409
        • David L. Rike Cancer Center at Miami Valley Hospital
      • Dayton, Ohio, Stati Uniti, 45415
        • Samaritan North Cancer Care Center
      • Dayton, Ohio, Stati Uniti, 45429
        • CCOP - Dayton
      • Findlay, Ohio, Stati Uniti, 45840
        • Blanchard Valley Medical Associates
      • Fremont, Ohio, Stati Uniti, 43420
        • Fremont Memorial Hospital
      • Kenton, Ohio, Stati Uniti, 43326
        • Kenton Oncology, Incorporated
      • Kettering, Ohio, Stati Uniti, 45429
        • Charles F. Kettering Memorial Hospital
      • Lima, Ohio, Stati Uniti, 45804
        • Lima Memorial Hospital
      • Maumee, Ohio, Stati Uniti, 43537
        • Northwest Ohio Oncology Center
      • Maumee, Ohio, Stati Uniti, 43537
        • St. Luke's Hospital
      • Middletown, Ohio, Stati Uniti, 45044
        • Middletown Regional Hospital
      • Oregon, Ohio, Stati Uniti, 43616
        • St. Charles Mercy Hospital
      • Oregon, Ohio, Stati Uniti, 43616
        • Toledo Clinic - Oregon
      • Sandusky, Ohio, Stati Uniti, 44870
        • Firelands Regional Medical Center
      • Sandusky, Ohio, Stati Uniti, 44870
        • North Coast Cancer Care, Incorporated
      • Sylvania, Ohio, Stati Uniti, 43560
        • Promedica Cancer Center at Flower Hospital
      • Tiffin, Ohio, Stati Uniti, 44883
        • Mercy Hospital of Tiffin
      • Toledo, Ohio, Stati Uniti, 43608
        • St. Vincent Mercy Medical Center
      • Toledo, Ohio, Stati Uniti, 43606
        • Toledo Hospital
      • Toledo, Ohio, Stati Uniti, 43623
        • CCOP - Toledo Community Hospital
      • Toledo, Ohio, Stati Uniti, 43614
        • Medical College of Ohio Cancer Institute
      • Toledo, Ohio, Stati Uniti, 43623
        • Toledo Surgical Specialists
      • Toledo, Ohio, Stati Uniti, 43623
        • Toledo Clinic, Incorporated
      • Troy, Ohio, Stati Uniti, 45373
        • UVMC Cancer Care Center at Upper Valley Medical Center
      • Wauseon, Ohio, Stati Uniti, 43567
        • Fulton County Health Center
      • Wright-Patterson Afb, Ohio, Stati Uniti, 45433-5529
        • United States Air Force Medical Center Wright-Patterson
      • Xenia, Ohio, Stati Uniti, 45385
        • Ruth G. McMillan Cancer Center at Greene Memorial Hospital
    • Oklahoma
      • Tulsa, Oklahoma, Stati Uniti, 74136
        • Natalie Warren Bryant Cancer Center at St. Francis Hospital
    • Pennsylvania
      • Danville, Pennsylvania, Stati Uniti, 17822-2001
        • Geisinger Medical Center
      • State College, Pennsylvania, Stati Uniti, 16801
        • Geisinger Medical Group
      • Wilkes-Barre, Pennsylvania, Stati Uniti, 18711
        • Geisinger Wyoming Valley Medical Center
    • South Carolina
      • Anderson, South Carolina, Stati Uniti, 29621
        • Rose Ramer Cancer Clinic at Anderson Area Medical Center
      • Spartanburg, South Carolina, Stati Uniti, 29303
        • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
      • Spartanburg, South Carolina, Stati Uniti, 29304
        • CCOP - Upstate Carolina
    • South Dakota
      • Sioux Falls, South Dakota, Stati Uniti, 57105
        • Medical X-Ray Center
      • Sioux Falls, South Dakota, Stati Uniti, 57104
        • Sioux Valley Hospital and University of South Dakota Medical Center
      • Sioux Falls, South Dakota, Stati Uniti, 57105
        • Avera McKennan Hospital and University Health Center
    • Wisconsin
      • Eau Claire, Wisconsin, Stati Uniti, 54702
        • Luther Mildelfort Hospital
      • Eau Claire, Wisconsin, Stati Uniti, 54702
        • Midelfort Clinic - Luther
      • Green Bay, Wisconsin, Stati Uniti, 54303
        • Green Bay Oncology, Limited at St. Mary's Hospital
      • Green Bay, Wisconsin, Stati Uniti, 54301-3526
        • Green Bay Oncology, Limited at St. Vincent Hospital
      • Green Bay, Wisconsin, Stati Uniti, 54301
        • St. Vincent Hospital
      • Green Bay, Wisconsin, Stati Uniti, 54303
        • St. Mary's Hospital Medical Center
      • La Crosse, Wisconsin, Stati Uniti, 54601
        • Franciscan Skemp Healthcare
      • Oconto Falls, Wisconsin, Stati Uniti, 54154
        • Green Bay Oncology, Limited - Oconto Falls
      • Sturgeon Bay, Wisconsin, Stati Uniti, 54235
        • Green Bay Oncology, Limited - Sturgeon Bay
    • Wyoming
      • Sheridan, Wyoming, Stati Uniti, 82801
        • Welch Cancer Center

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Droga: docetaxel
Biologico: infliximab
Comparatore attivo: 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.
Droga: docetaxel
Altro: placebo

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Assessment of weight
Lasso di tempo: Up to 5 years
Up to 5 years
Rate of weight change
Lasso di tempo: Up to 5 years
Up to 5 years

Misure di risultato secondarie

Misura del risultato
Lasso di tempo
Sopravvivenza globale
Lasso di tempo: Fino a 5 anni
Fino a 5 anni
Qualità della vita
Lasso di tempo: Fino a 5 anni
Fino a 5 anni
Incidenza della tossicità correlata al trattamento
Lasso di tempo: Fino a 5 anni
Fino a 5 anni
Cancer-related fatigue as measured by the Brief Fatigue Inventory
Lasso di tempo: Up to 5 years
Up to 5 years
Time-to-weight decline
Lasso di tempo: Up to 5 years
Up to 5 years
Appetite
Lasso di tempo: Up to 5 years
Up to 5 years
Lean tissue changes
Lasso di tempo: Up to 5 years
Up to 5 years

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Alliance for Clinical Trials in Oncology

Collaboratori

National Cancer Institute (NCI)

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 ottobre 2002

Completamento primario (Effettivo)

1 febbraio 2006

Completamento dello studio (Effettivo)

1 ottobre 2008

Date di iscrizione allo studio

Primo inviato

8 luglio 2002

Primo inviato che soddisfa i criteri di controllo qualità

26 gennaio 2003

Primo Inserito (Stima)

27 gennaio 2003

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

7 dicembre 2016

Ultimo aggiornamento inviato che soddisfa i criteri QC

5 dicembre 2016

Ultimo verificato

1 dicembre 2016

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • NCCTG-N01C9
  • NCI-2012-02472 (Identificatore di registro: CTRP (Clinical Trials Reporting System))
  • NCI-P02-0226
  • CDR0000069417 (Identificatore di registro: PDQ (Physician Data Query))

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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