Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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. desember 2016 oppdatert av: 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)

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

OBJECTIVES:

  • Compare the improvement or stabilization of weight in elderly or poor performance status patients with unresectable non-small cell lung cancer treated with docetaxel with or without infliximab (infliximab treatment discontinued effective 10/05/05).
  • Compare appetite and functional status in patients treated with these regimens.
  • Compare the toxicity of these regimens in these patients.
  • Compare the augmentation or maintenance of lean tissue in patients treated with these regimens.
  • Compare the response rates and time to disease progression in patients treated with these regimens.
  • Compare the survival of patients treated with these regimens.
  • Determine whether the tumor necrosis factor-alpha polymorphisms in the -308 and -238 regions predict which cancer patients will experience loss of appetite and weight and which patients might potentially benefit from infliximab (infliximab treatment discontinued effective 10/05/05).

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to weight loss within the past 6 months (0% vs more than 0% to less than 5% vs at least 5%), number of prior chemotherapy regimens (0 vs 1 vs more than 1), gender, and GBU prognostic index (good vs bad vs unsure).

  • Part A (non-randomized, single-center portion of study): Five patients receive infliximab IV (infliximab treatment discontinued effective 10/05/05) over 2 hours once weekly on weeks 1, 3, and 5 of the first course and once weekly on weeks 1 and 5 of all subsequent courses and docetaxel IV over 1 hour (immediately after completion of infliximab infusion [infliximab treatment discontinued effective 10/05/05]) once weekly on weeks 1-6 of each course. Treatment repeats every 8 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity.

If none of the 5 patients experiences any grade 4 or 5 toxicity directly attributable to infliximab (infliximab treatment discontinued effective 10/05/05), additional patients are accrued for part B of the study.

  • Part B (randomized, multicenter portion of study): Patients are randomized to 1 of 2 treatment arms.

    • Arm I (infliximab treatment discontinued effective 10/05/05): Patients receive infliximab and docetaxel as in part A.
    • Arm II: Patients receive docetaxel as in part A and placebo IV over 2 hours according to the infliximab schedule in part A (infliximab treatment discontinued effective 10/05/05).

Treatment in both arms repeats as in part A.

Quality of life, fatigue, appetite/anorexia, cachexia, and weight are assessed at baseline, weekly on weeks 1-8, and then monthly for the remainder of study treatment.

Patients are followed every 6 months for 5 years.

Studietype

Intervensjonell

Registrering (Faktiske)

67

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed unresectable non-small cell lung cancer that is considered incurable with other therapies
  • Chemotherapy naive or previously treated disease

  • Meets one of the following criteria:

    • Age 65 and over with ECOG performance status of 0-2
    • Under age 65 with ECOG performance status of 2
  • No symptomatic or known untreated brain metastases

PATIENT CHARACTERISTICS:

Age:

  • See Disease Characteristics
  • Adult

Performance status:

  • See Disease Characteristics
  • ECOG 0-2

Life expectancy:

  • At least 3 months

Hematopoietic:

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic:

  • Bilirubin normal
  • AST and/or ALT ≤ 2.5 times upper limit of normal (ULN) if alkaline phosphatase less than ULN OR
  • Alkaline phosphatase ≤ 4 times ULN if ALT less than ULN
  • No ascites

Renal:

  • Creatinine ≤ 1.5 times ULN

Cardiovascular:

  • No prior or concurrent congestive heart failure

Pulmonary:

  • No prior tuberculosis or positive purified protein derivative skin test (tuberculin test)

Other:

  • No prior anaphylactic reaction to any taxane
  • No known mechanical obstruction of the alimentary tract, malabsorption, or intractable vomiting (more than 5 episodes per week)
  • No infection or chronic debilitating illness that would increase the risk of chemotherapy administration
  • No grade 2 or greater peripheral neuropathy of any etiology
  • No edema
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer
  • Alert and mentally competent
  • Able to complete questionnaires alone or with assistance
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • See Disease Characteristics
  • No prior docetaxel for metastatic non-small cell lung cancer

Endocrine therapy:

  • At least 1 month since prior adrenal steroids, androgens, progestational agents, or appetite stimulants
  • No concurrent adrenal steroids, androgens, progestational agents, or appetite stimulants unless needed (e.g., steroids for CNS metastases)
  • Concurrent inhaled, topical, or optical steroids allowed
  • Concurrent short-term dexamethasone around days of chemotherapy administration allowed for protection against anaphylaxis and emesis

Radiotherapy:

  • More than 3 weeks since prior radiotherapy
  • No prior radiotherapy to more than 25% of bone marrow

Surgery:

  • More than 3 weeks since prior major surgery

Other:

  • More than 3 weeks since other prior antineoplastic therapy

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Legemiddel: docetaksel
Biologisk: infliximab
Aktiv komparator: placebo + docetaxel

Patients receive docetaxel IV over 1 hour (immediately after completion of infliximab infusion once weekly on weeks 1-6 of each course. Patients receive placebo IV over 2 hours once weekly on weeks 1, 3, and 5 of the first course and once weekly on weeks 1 and 5 of all subsequent courses.

Treatment repeats every 8 weeks for 2-3 courses in the absence of disease progression or unacceptable toxicity.

Quality of life, fatigue, appetite/anorexia, cachexia, and weight are assessed at baseline, weekly on weeks 1-8, and then monthly for the remainder of study treatment.

Patients are followed every 6 months for 5 years.
Legemiddel: docetaksel
Annen: placebo

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Assessment of weight
Tidsramme: Up to 5 years
Up to 5 years
Rate of weight change
Tidsramme: Up to 5 years
Up to 5 years

Sekundære resultatmål

Resultatmål
Tidsramme
Total overlevelse
Tidsramme: Inntil 5 år
Inntil 5 år
Livskvalitet
Tidsramme: Inntil 5 år
Inntil 5 år
Forekomst av behandlingsrelatert toksisitet
Tidsramme: Inntil 5 år
Inntil 5 år
Cancer-related fatigue as measured by the Brief Fatigue Inventory
Tidsramme: Up to 5 years
Up to 5 years
Time-to-weight decline
Tidsramme: Up to 5 years
Up to 5 years
Appetite
Tidsramme: Up to 5 years
Up to 5 years
Lean tissue changes
Tidsramme: Up to 5 years
Up to 5 years

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Alliance for Clinical Trials in Oncology

Samarbeidspartnere

National Cancer Institute (NCI)

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. oktober 2002

Primær fullføring (Faktiske)

1. februar 2006

Studiet fullført (Faktiske)

1. oktober 2008

Datoer for studieregistrering

Først innsendt

8. juli 2002

Først innsendt som oppfylte QC-kriteriene

26. januar 2003

Først lagt ut (Anslag)

27. januar 2003

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

7. desember 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. desember 2016

Sist bekreftet

1. desember 2016

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere