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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Anorexia, Cachexia, Fatigue, Lung Cancer

Thank you

Trial Information

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


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.

PROJECTED ACCRUAL: A total of 220 patients (110 per treatment arm) will be accrued for this
study within 3 years.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care

Outcome Measure:

Assessment of weight

Principal Investigator

Aminah Jatoi, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000069417

NCT ID:

NCT00040885

Start Date:

October 2002

Completion Date:

Related Keywords:

  • Anorexia
  • Cachexia
  • Fatigue
  • Lung Cancer
  • recurrent non-small cell lung cancer
  • stage IIIA non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • fatigue
  • anorexia
  • cachexia
  • Anorexia
  • Cachexia
  • Carcinoma, Non-Small-Cell Lung
  • Fatigue
  • Lung Neoplasms

Name

Location

Mayo Clinic - JacksonvilleJacksonville, Florida  32224
Mayo Clinic Cancer CenterRochester, Minnesota  55905
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Bergan Mercy Medical CenterOmaha, Nebraska  68124
Aurora Presbyterian HospitalAurora, Colorado  80012
Boulder Community HospitalBoulder, Colorado  80301-9019
Penrose Cancer Center at Penrose HospitalColorado Springs, Colorado  80933
Porter Adventist HospitalDenver, Colorado  80210
Presbyterian - St. Luke's Medical CenterDenver, Colorado  80218
St. Joseph HospitalDenver, Colorado  80218
Rose Medical CenterDenver, Colorado  80220
Swedish Medical CenterEnglewood, Colorado  80110
Sky Ridge Medical CenterLone Tree, Colorado  80124
Hope Cancer Care Center at Longmont United HospitalLongmont, Colorado  80502
North Suburban Medical CenterThornton, Colorado  80229
Rush-Copley Cancer Care CenterAurora, Illinois  60507
Carle Cancer Center at Carle Foundation HospitalUrbana, Illinois  61801
Saint Anthony Memorial Health CentersMichigan City, Indiana  46360
Cedar Rapids Oncology AssociatesCedar Rapids, Iowa  52403
Mercy Medical Center - Sioux CitySioux City, Iowa  51104
St. Luke's Regional Medical CenterSioux City, Iowa  51104
Fairview Ridges HospitalBurnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy HospitalCoon Rapids, Minnesota  55433
CCOP - DuluthDuluth, Minnesota  55805
Fairview Southdale HospitalEdina, Minnesota  55435
Mercy and Unity Cancer Center at Unity HospitalFridley, Minnesota  55432
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
CCOP - MeritCare HospitalFargo, North Dakota  58122
Natalie Warren Bryant Cancer Center at St. Francis HospitalTulsa, Oklahoma  74136
Geisinger Medical CenterDanville, Pennsylvania  17822-0001
Methodist Medical Center of IllinoisPeoria, Illinois  61636
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
Veterans Affairs Medical Center - DaytonDayton, Ohio  45428
CCOP - DaytonKettering, Ohio  45429
St. Vincent HospitalGreen Bay, Wisconsin  54307-3508
John Stoddard Cancer Center at Iowa Methodist Medical CenterDes Moines, Iowa  50309
Midlands Cancer Center at Midlands Community HospitalPapillion, Nebraska  68128-4157
St. Vincent Mercy Medical CenterToledo, Ohio  43608
CCOP - Colorado Cancer Research Program, IncorporatedDenver, Colorado  80224
Great Falls ClinicGreat Falls, Montana  59405
Sioux Valley Hospital and University of South Dakota Medical CenterSioux Falls, South Dakota  57117-5134
CCOP - Toledo Community HospitalToledo, Ohio  43623-3456
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
Toledo HospitalToledo, Ohio  43606
St. Mary's - Duluth Clinic Cancer CenterDuluth, Minnesota  55805
Green Bay Oncology, Limited - EscanabaEscanaba, Michigan  49431
Green Bay Oncology, Limited at St. Mary's HospitalGreen Bay, Wisconsin  54303
Green Bay Oncology, Limited - Oconto FallsOconto Falls, Wisconsin  54154
Green Bay Oncology, Limited - Sturgeon BaySturgeon Bay, Wisconsin  54235
Siouxland Hematology-Oncology AssociatesSioux City, Iowa  51101
Siouxland Regional Cancer CenterSioux City, Iowa  51101-1733
Cancer Center of Kansas - ChanuteChanute, Kansas  66720
Cancer Center of Kansas - Dodge CityDodge City, Kansas  67801
Cancer Center of Kansas, P.A. - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas - KingmanKingman, Kansas  67068
Southwest Medical CenterLiberal, Kansas  67901
Cancer Center of Kansas - NewtonNewton, Kansas  67114
Cancer Center of Kansas, P.A. - ParsonsParsons, Kansas  67357
Pratt Cancer Center of KansasPratt, Kansas  67124
Cancer Center of Kansas - SalinaSalina, Kansas  67042
Cancer Center of Kansas - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, P.A.Wichita, Kansas  67208
Associates in Womens HealthWichita, Kansas  67203
Cancer Center of Kansas, P.A. - WichitaWichita, Kansas  67214
Cancer Center of Kansas - WinfieldWinfield, Kansas  67156
Northern Rockies Radiation Oncology CenterBillings, Montana  59101
St. Vincent HealthcareBillings, Montana  59101
Deaconess Billings Clinic - DowntownBillings, Montana  59101
Deaconess Billings Clinic Cancer CenterBillings, Montana  59107
Bozeman Deaconess HospitalBozeman, Montana  59715
St. James Community HospitalButte, Montana  59701
Sletten Regional Cancer InstituteGreat Falls, Montana  59405
St. Peter's HospitalHelena, Montana  59601
Kalispell Regional Medical CenterKalispell, Montana  59901
Eastern Montana Cancer CenterMiles City, Montana  59301
Montana Cancer Center at St. Patrick Hospital and Health Sciences CenterMissoula, Montana  59802
Community Medical CenterMissoula, Montana  59801
Avera McKennan Hospital and University Health CenterSioux Falls, South Dakota  57105
Medical X-Ray CenterSioux Falls, South Dakota  57105
Welch Cancer CenterSheridan, Wyoming  82801
Oncology/Hematology Associates of Central Illinois, P.C.Peoria, Illinois  61602
St. Mary-Corwin Regional Medical CenterPueblo, Colorado  81004
St. Joseph Medical CenterBloomington, Illinois  61701
Graham HospitalCanton, Illinois  61520
Memorial HospitalCarthage, Illinois  62321
Eureka Community HospitalEureka, Illinois  61530
Galesburg Cottage HospitalGalesburg, Illinois  61401
Galesburg ClinicGalesburg, Illinois  61401
InterCommunity Cancer Center of Western IllinoisGalesburg, Illinois  61401
Mason District HospitalHavana, Illinois  62644
Hopedale Medical ComplexHopedale, Illinois  61747
Kewanee HospitalKewanee, Illinois  61443
McDonough District HospitalMacomb, Illinois  61455
BroMenn Regional Medical CenterNormal, Illinois  61761
Community Cancer CenterNormal, Illinois  61761
Community Hospital of OttawaOttawa, Illinois  61350
Cancer Treatment Center at Pekin HospitalPekin, Illinois  61554
OSF St. Francis Medical CenterPeoria, Illinois  61637
Proctor HospitalPeoria, Illinois  61614
Illinois Valley Community HospitalPeru, Illinois  61354
Perry Memorial HospitalPrinceton, Illinois  61356
St. Margaret's HospitalSpring Valley, Illinois  61362
Valley Cancer CenterSpring Valley, Illinois  61362
St. Luke's HospitalCedar Rapids, Iowa  52402
John Stoddard Cancer Center at Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
Mercy Capitol HospitalDes Moines, Iowa  50307
Medical Oncology and Hematology Associates at John Stoddard Cancer CenterDes Moines, Iowa  50309
Medical Oncology and Hematology Associates at Mercy Cancer CenterDes Moines, Iowa  50314
Mercy Cancer Center at Mercy Medical Center - Des MoinesDes Moines, Iowa  50314
Burgess Health CenterOnawa, Iowa  51040
Medical Oncology and Hematology Associates - West Des MoinesWest Des Moines, Iowa  50266
Hickman Cancer Center at Bixby Medical CenterAdrian, Michigan  49221
Green Bay Oncology, Limited - Iron MountainIron Mountain, Michigan  49801
Haematology-Oncology Associates of Ohio and Michigan, P.C.Lambertville, Michigan  48144
Community Cancer Center of MonroeMonroe, Michigan  48162
Mercy Memorial Hospital SystemMonroe, Michigan  48162
MeritCare Clinic - BemidjiBemidji, Minnesota  56601
Brainerd Medical CenterBrainerd, Minnesota  56401
St. Joseph's Medical CenterBrainerd, Minnesota  56401
Virginia Piper Cancer Institute at Abbott-Northwestern HospitalMinneapolis, Minnesota  55407
Chippewa County - Montevideo HospitalMontevideo, Minnesota  56265
Hubert H. Humphrey Cancer Center at North Memorial Medical CenterRobbinsdale, Minnesota  55422-2900
CentraCare Clinic - River CampusSt. Cloud, Minnesota  56303
Park Nicollet Health ServicesSt. Louis Park, Minnesota  55416
Immanuel Medical CenterOmaha, Nebraska  68122
Creighton University Medical CenterOmaha, Nebraska  68131-2197
Cancer Care Center at Medcenter One HospitalBismarck, North Dakota  58501
Bismarck Cancer CenterBismarck, North Dakota  58501
St. Alexius Medical CenterBismarck, North Dakota  58502
MeritCare Medical GroupFargo, North Dakota  58122
Wood County Oncology CenterBowling Green, Ohio  43402
Samaritan North Cancer Care CenterDayton, Ohio  45415
Grandview HospitalDayton, Ohio  45405
David L. Rike Cancer Center at Miami Valley HospitalDayton, Ohio  45409
Good Samaritan HospitalDayton, Ohio  45406
Blanchard Valley Medical AssociatesFindlay, Ohio  45840
Fremont Memorial HospitalFremont, Ohio  43420
Kenton Oncology, IncorporatedKenton, Ohio  43326
Charles F. Kettering Memorial HospitalKettering, Ohio  45429
Lima Memorial HospitalLima, Ohio  45804
St. Luke's HospitalMaumee, Ohio  43537
Northwest Ohio Oncology CenterMaumee, Ohio  43537
Middletown Regional HospitalMiddletown, Ohio  45044
Toledo Clinic - OregonOregon, Ohio  43616
St. Charles Mercy HospitalOregon, Ohio  43616
North Coast Cancer Care, IncorporatedSandusky, Ohio  44870
Firelands Regional Medical CenterSandusky, Ohio  44870
Promedica Cancer Center at Flower HospitalSylvania, Ohio  43560
Mercy Hospital of TiffinTiffin, Ohio  44883
Toledo Surgical SpecialistsToledo, Ohio  43623
UVMC Cancer Care Center at Upper Valley Medical CenterTroy, Ohio  45373-1300
Fulton County Health CenterWauseon, Ohio  43567
Ruth G. McMillan Cancer Center at Greene Memorial HospitalXenia, Ohio  45385
Green Bay Oncology, Limited at St. Vincent HospitalGreen Bay, Wisconsin  54301-3526
Joliet Oncology Hematology Associates, Limited - WestJoliet, Illinois  60435
Oncology Hematology Associates of Central Illinois - OttawaOttawa, Illinois  61350
Rose Ramer Cancer Clinic at Anderson Area Medical CenterAnderson, South Carolina  29621
Saint Anthony Regional HospitalCarroll, Iowa  51401
Miller-Dwan Medical CenterDuluth, Minnesota  55805
St. Cloud HospitalSaint Cloud, Minnesota  56303
Fremont Area Medical CenterFremont, Nebraska  68025-2387
Mid Dakota Clinic, P.C.Bismarck, North Dakota  58501
Geisinger Medical GroupState College, Pennsylvania  16801
Geisinger Wyoming Valley Medical CenterWilkes-Barre, Pennsylvania  18711
Franciscan Skemp HealthcareLa Crosse, Wisconsin  54601-4796
CCOP - Mayo Clinic Scottsdale Oncology ProgramScottsdale, Arizona  85259
St. Francis Hospital and Health CentersBeech Grove, Indiana  46107
Mercy Cancer Center at Mercy Medical CenterCedar Rapids, Iowa  52403
Alegent Health Mercy HospitalCouncil Bluffs, Iowa  51503
Mercy Cancer Center at Mercy Medical Center - North IowaMason City, Iowa  50401
Alegent Health Community Memorial HospitalMissouri Valley, Iowa  51555
Adult and Pediatric Urology, P.L.L.P.St. Cloud, Minnesota  56303
Medical College of Ohio Cancer InstituteToledo, Ohio  43614
Toledo Clinic, IncorporatedToledo, Ohio  43623
Midelfort Clinic - LutherEau Claire, Wisconsin  54702
Luther Mildelfort HospitalEau Claire, Wisconsin  54702
St. Mary's Hospital Medical CenterGreen Bay, Wisconsin  54303
Rutherford HospitalRutherfordton, North Carolina  28139
Gibbs Regional Cancer Center at Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
United States Air Force Medical Center Wright-PattersonWright-Patterson Afb, Ohio  45433-5529
Ottumwa Regional Health Center Cancer CenterOttumwa, Iowa  52501