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Spots Global Cancer Trial Database for 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)

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Trial Identification

Brief Title: 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)

Official Title: 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

Study ID: NCT00040885

Study Description

Brief Summary: 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)

Detailed Description: 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

CCOP - Mayo Clinic Scottsdale Oncology Program, Scottsdale, Arizona, United States

Aurora Presbyterian Hospital, Aurora, Colorado, United States

Boulder Community Hospital, Boulder, Colorado, United States

Penrose Cancer Center at Penrose Hospital, Colorado Springs, Colorado, United States

Porter Adventist Hospital, Denver, Colorado, United States

Presbyterian - St. Luke's Medical Center, Denver, Colorado, United States

St. Joseph Hospital, Denver, Colorado, United States

Rose Medical Center, Denver, Colorado, United States

CCOP - Colorado Cancer Research Program, Incorporated, Denver, Colorado, United States

Swedish Medical Center, Englewood, Colorado, United States

Sky Ridge Medical Center, Lone Tree, Colorado, United States

Hope Cancer Care Center at Longmont United Hospital, Longmont, Colorado, United States

St. Mary-Corwin Regional Medical Center, Pueblo, Colorado, United States

North Suburban Medical Center, Thorton, Colorado, United States

Mayo Clinic - Jacksonville, Jacksonville, Florida, United States

Rush-Copley Cancer Care Center, Aurora, Illinois, United States

St. Joseph Medical Center, Bloomington, Illinois, United States

Graham Hospital, Canton, Illinois, United States

Memorial Hospital, Carthage, Illinois, United States

Eureka Community Hospital, Eureka, Illinois, United States

Galesburg Clinic, Galesburg, Illinois, United States

Galesburg Cottage Hospital, Galesburg, Illinois, United States

InterCommunity Cancer Center of Western Illinois, Galesburg, Illinois, United States

Mason District Hospital, Havana, Illinois, United States

Hopedale Medical Complex, Hopedale, Illinois, United States

Joliet Oncology Hematology Associates, Limited - West, Joliet, Illinois, United States

Kewanee Hospital, Kewanee, Illinois, United States

McDonough District Hospital, Macomb, Illinois, United States

BroMenn Regional Medical Center, Normal, Illinois, United States

Community Cancer Center, Normal, Illinois, United States

Community Hospital of Ottawa, Ottawa, Illinois, United States

Oncology Hematology Associates of Central Illinois - Ottawa, Ottawa, Illinois, United States

Cancer Treatment Center at Pekin Hospital, Pekin, Illinois, United States

Methodist Medical Center of Illinois, Peoria, Illinois, United States

Proctor Hospital, Peoria, Illinois, United States

CCOP - Illinois Oncology Research Association, Peoria, Illinois, United States

Oncology/Hematology Associates of Central Illinois, P.C., Peoria, Illinois, United States

OSF St. Francis Medical Center, Peoria, Illinois, United States

Illinois Valley Community Hospital, Peru, Illinois, United States

Perry Memorial Hospital, Princeton, Illinois, United States

St. Margaret's Hospital, Spring Valley, Illinois, United States

Valley Cancer Center, Spring Valley, Illinois, United States

Carle Cancer Center at Carle Foundation Hospital, Urbana, Illinois, United States

CCOP - Carle Cancer Center, Urbana, Illinois, United States

St. Francis Hospital and Health Centers, Beech Grove, Indiana, United States

Saint Anthony Memorial Health Centers, Michigan City, Indiana, United States

Saint Anthony Regional Hospital, Carroll, Iowa, United States

St. Luke's Hospital, Cedar Rapids, Iowa, United States

Cedar Rapids Oncology Associates, Cedar Rapids, Iowa, United States

Mercy Cancer Center at Mercy Medical Center, Cedar Rapids, Iowa, United States

Alegent Health Mercy Hospital, Council Bluffs, Iowa, United States

Mercy Capitol Hospital, Des Moines, Iowa, United States

CCOP - Iowa Oncology Research Association, Des Moines, Iowa, United States

John Stoddard Cancer Center at Iowa Methodist Medical Center, Des Moines, Iowa, United States

Medical Oncology and Hematology Associates at John Stoddard Cancer Center, Des Moines, Iowa, United States

Medical Oncology and Hematology Associates at Mercy Cancer Center, Des Moines, Iowa, United States

Mercy Cancer Center at Mercy Medical Center - Des Moines, Des Moines, Iowa, United States

John Stoddard Cancer Center at Iowa Lutheran Hospital, Des Moines, Iowa, United States

Mercy Cancer Center at Mercy Medical Center - North Iowa, Mason City, Iowa, United States

Alegent Health Community Memorial Hospital, Missouri Valley, Iowa, United States

Burgess Health Center, Onawa, Iowa, United States

Ottumwa Regional Health Center Cancer Center, Ottumwa, Iowa, United States

Siouxland Regional Cancer Center, Sioux City, Iowa, United States

Siouxland Hematology-Oncology Associates, Sioux City, Iowa, United States

Mercy Medical Center - Sioux City, Sioux City, Iowa, United States

St. Luke's Regional Medical Center, Sioux City, Iowa, United States

Medical Oncology and Hematology Associates - West Des Moines, West Des Moines, Iowa, United States

Cancer Center of Kansas - Chanute, Chanute, Kansas, United States

Cancer Center of Kansas - Dodge City, Dodge City, Kansas, United States

Cancer Center of Kansas, P.A. - El Dorado, El Dorado, Kansas, United States

Cancer Center of Kansas - Kingman, Kingman, Kansas, United States

Southwest Medical Center, Liberal, Kansas, United States

Cancer Center of Kansas - Newton, Newton, Kansas, United States

Cancer Center of Kansas, P.A. - Parsons, Parsons, Kansas, United States

Pratt Cancer Center of Kansas, Pratt, Kansas, United States

Cancer Center of Kansas - Salina, Salina, Kansas, United States

Cancer Center of Kansas - Wellington, Wellington, Kansas, United States

Associates in Womens Health, Wichita, Kansas, United States

Cancer Center of Kansas, P.A., Wichita, Kansas, United States

Cancer Center of Kansas, P.A. - Wichita, Wichita, Kansas, United States

CCOP - Wichita, Wichita, Kansas, United States

Via Christi Cancer Center at Via Christi Regional Medical Center, Wichita, Kansas, United States

Cancer Center of Kansas - Winfield, Winfield, Kansas, United States

Hickman Cancer Center at Bixby Medical Center, Adrian, Michigan, United States

Green Bay Oncology, Limited - Escanaba, Escanaba, Michigan, United States

Green Bay Oncology, Limited - Iron Mountain, Iron Mountain, Michigan, United States

Haematology-Oncology Associates of Ohio and Michigan, P.C., Lambertville, Michigan, United States

Community Cancer Center of Monroe, Monroe, Michigan, United States

Mercy Memorial Hospital System, Monroe, Michigan, United States

MeritCare Clinic - Bemidji, Bemidji, Minnesota, United States

Brainerd Medical Center, Brainerd, Minnesota, United States

St. Joseph's Medical Center, Brainerd, Minnesota, United States

Fairview Ridges Hospital, Burnsville, Minnesota, United States

Mercy and Unity Cancer Center at Mercy Hospital, Coon Rapids, Minnesota, United States

CCOP - Duluth, Duluth, Minnesota, United States

Miller-Dwan Medical Center, Duluth, Minnesota, United States

St. Mary's - Duluth Clinic Cancer Center, Duluth, Minnesota, United States

Fairview Southdale Hospital, Edina, Minnesota, United States

Mercy and Unity Cancer Center at Unity Hospital, Fridley, Minnesota, United States

Virginia Piper Cancer Institute at Abbott-Northwestern Hospital, Minneapolis, Minnesota, United States

Chippewa County - Montevideo Hospital, Montevideo, Minnesota, United States

Hubert H. Humphrey Cancer Center at North Memorial Medical Center, Robbinsdale, Minnesota, United States

Mayo Clinic Cancer Center, Rochester, Minnesota, United States

St. Cloud Hospital, Saint Cloud, Minnesota, United States

CCOP - Metro-Minnesota, Saint Louis Park, Minnesota, United States

Adult and Pediatric Urology, P.L.L.P., St. Cloud, Minnesota, United States

CentraCare Clinic - River Campus, St. Cloud, Minnesota, United States

Park Nicollet Health Services, St. Louis Park, Minnesota, United States

United Hospital, St. Paul, Minnesota, United States

Ridgeview Medical Center, Waconia, Minnesota, United States

CCOP - Montana Cancer Consortium, Billings, Montana, United States

Deaconess Billings Clinic - Downtown, Billings, Montana, United States

Northern Rockies Radiation Oncology Center, Billings, Montana, United States

St. Vincent Healthcare, Billings, Montana, United States

Deaconess Billings Clinic Cancer Center, Billings, Montana, United States

Bozeman Deaconess Hospital, Bozeman, Montana, United States

St. James Community Hospital, Butte, Montana, United States

Great Falls Clinic, Great Falls, Montana, United States

Sletten Regional Cancer Institute, Great Falls, Montana, United States

St. Peter's Hospital, Helena, Montana, United States

Kalispell Regional Medical Center, Kalispell, Montana, United States

Eastern Montana Cancer Center, Miles City, Montana, United States

Community Medical Center, Missoula, Montana, United States

Montana Cancer Center at St. Patrick Hospital and Health Sciences Center, Missoula, Montana, United States

Fremont Area Medical Center, Fremont, Nebraska, United States

CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska, United States

Immanuel Medical Center, Omaha, Nebraska, United States

Bergan Mercy Medical Center, Omaha, Nebraska, United States

Creighton University Medical Center, Omaha, Nebraska, United States

Midlands Cancer Center at Midlands Community Hospital, Papillion, Nebraska, United States

Rutherford Hospital, Rutherfordton, North Carolina, United States

Bismarck Cancer Center, Bismarck, North Dakota, United States

Cancer Care Center at Medcenter One Hospital, Bismarck, North Dakota, United States

Mid Dakota Clinic, P.C., Bismarck, North Dakota, United States

St. Alexius Medical Center, Bismarck, North Dakota, United States

CCOP - MeritCare Hospital, Fargo, North Dakota, United States

MeritCare Medical Group, Fargo, North Dakota, United States

Wood County Oncology Center, Bowling Green, Ohio, United States

Grandview Hospital, Dayton, Ohio, United States

Good Samaritan Hospital, Dayton, Ohio, United States

David L. Rike Cancer Center at Miami Valley Hospital, Dayton, Ohio, United States

Samaritan North Cancer Care Center, Dayton, Ohio, United States

Veterans Affairs Medical Center - Dayton, Dayton, Ohio, United States

CCOP - Dayton, Dayton, Ohio, United States

Blanchard Valley Medical Associates, Findlay, Ohio, United States

Fremont Memorial Hospital, Fremont, Ohio, United States

Kenton Oncology, Incorporated, Kenton, Ohio, United States

Charles F. Kettering Memorial Hospital, Kettering, Ohio, United States

Lima Memorial Hospital, Lima, Ohio, United States

Northwest Ohio Oncology Center, Maumee, Ohio, United States

St. Luke's Hospital, Maumee, Ohio, United States

Middletown Regional Hospital, Middletown, Ohio, United States

St. Charles Mercy Hospital, Oregon, Ohio, United States

Toledo Clinic - Oregon, Oregon, Ohio, United States

Firelands Regional Medical Center, Sandusky, Ohio, United States

North Coast Cancer Care, Incorporated, Sandusky, Ohio, United States

Promedica Cancer Center at Flower Hospital, Sylvania, Ohio, United States

Mercy Hospital of Tiffin, Tiffin, Ohio, United States

Toledo Hospital, Toledo, Ohio, United States

St. Vincent Mercy Medical Center, Toledo, Ohio, United States

Medical College of Ohio Cancer Institute, Toledo, Ohio, United States

CCOP - Toledo Community Hospital, Toledo, Ohio, United States

Toledo Clinic, Incorporated, Toledo, Ohio, United States

Toledo Surgical Specialists, Toledo, Ohio, United States

UVMC Cancer Care Center at Upper Valley Medical Center, Troy, Ohio, United States

Fulton County Health Center, Wauseon, Ohio, United States

United States Air Force Medical Center Wright-Patterson, Wright-Patterson Afb, Ohio, United States

Ruth G. McMillan Cancer Center at Greene Memorial Hospital, Xenia, Ohio, United States

Natalie Warren Bryant Cancer Center at St. Francis Hospital, Tulsa, Oklahoma, United States

Geisinger Medical Center, Danville, Pennsylvania, United States

Geisinger Medical Group, State College, Pennsylvania, United States

Geisinger Wyoming Valley Medical Center, Wilkes-Barre, Pennsylvania, United States

Rose Ramer Cancer Clinic at Anderson Area Medical Center, Anderson, South Carolina, United States

Gibbs Regional Cancer Center at Spartanburg Regional Medical Center, Spartanburg, South Carolina, United States

CCOP - Upstate Carolina, Spartanburg, South Carolina, United States

Sioux Valley Hospital and University of South Dakota Medical Center, Sioux Falls, South Dakota, United States

Avera McKennan Hospital and University Health Center, Sioux Falls, South Dakota, United States

Medical X-Ray Center, Sioux Falls, South Dakota, United States

Luther Mildelfort Hospital, Eau Claire, Wisconsin, United States

Midelfort Clinic - Luther, Eau Claire, Wisconsin, United States

Green Bay Oncology, Limited at St. Vincent Hospital, Green Bay, Wisconsin, United States

St. Vincent Hospital, Green Bay, Wisconsin, United States

Green Bay Oncology, Limited at St. Mary's Hospital, Green Bay, Wisconsin, United States

St. Mary's Hospital Medical Center, Green Bay, Wisconsin, United States

Franciscan Skemp Healthcare, La Crosse, Wisconsin, United States

Green Bay Oncology, Limited - Oconto Falls, Oconto Falls, Wisconsin, United States

Green Bay Oncology, Limited - Sturgeon Bay, Sturgeon Bay, Wisconsin, United States

Welch Cancer Center, Sheridan, Wyoming, United States

Contact Details

Name: Aminah Jatoi, MD

Affiliation: Mayo Clinic

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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