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)
Anorexia, Cachexia, Fatigue
About this trial
This is an interventional supportive care trial for Anorexia focused on measuring 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
Eligibility 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
Sites / Locations
- CCOP - Mayo Clinic Scottsdale Oncology Program
- Aurora Presbyterian Hospital
- Boulder Community Hospital
- Penrose Cancer Center at Penrose Hospital
- Porter Adventist Hospital
- Presbyterian - St. Luke's Medical Center
- St. Joseph Hospital
- Rose Medical Center
- CCOP - Colorado Cancer Research Program, Incorporated
- Swedish Medical Center
- Sky Ridge Medical Center
- Hope Cancer Care Center at Longmont United Hospital
- St. Mary-Corwin Regional Medical Center
- North Suburban Medical Center
- Mayo Clinic - Jacksonville
- Rush-Copley Cancer Care Center
- St. Joseph Medical Center
- Graham Hospital
- Memorial Hospital
- Eureka Community Hospital
- Galesburg Clinic
- Galesburg Cottage Hospital
- InterCommunity Cancer Center of Western Illinois
- Mason District Hospital
- Hopedale Medical Complex
- Joliet Oncology Hematology Associates, Limited - West
- Kewanee Hospital
- McDonough District Hospital
- BroMenn Regional Medical Center
- Community Cancer Center
- Community Hospital of Ottawa
- Oncology Hematology Associates of Central Illinois - Ottawa
- Cancer Treatment Center at Pekin Hospital
- Methodist Medical Center of Illinois
- Proctor Hospital
- CCOP - Illinois Oncology Research Association
- Oncology/Hematology Associates of Central Illinois, P.C.
- OSF St. Francis Medical Center
- Illinois Valley Community Hospital
- Perry Memorial Hospital
- St. Margaret's Hospital
- Valley Cancer Center
- Carle Cancer Center at Carle Foundation Hospital
- CCOP - Carle Cancer Center
- St. Francis Hospital and Health Centers
- Saint Anthony Memorial Health Centers
- Saint Anthony Regional Hospital
- St. Luke's Hospital
- Cedar Rapids Oncology Associates
- Mercy Cancer Center at Mercy Medical Center
- Alegent Health Mercy Hospital
- Mercy Capitol Hospital
- CCOP - Iowa Oncology Research Association
- John Stoddard Cancer Center at Iowa Methodist Medical Center
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
- Medical Oncology and Hematology Associates at Mercy Cancer Center
- Mercy Cancer Center at Mercy Medical Center - Des Moines
- John Stoddard Cancer Center at Iowa Lutheran Hospital
- Mercy Cancer Center at Mercy Medical Center - North Iowa
- Alegent Health Community Memorial Hospital
- Burgess Health Center
- Ottumwa Regional Health Center Cancer Center
- Siouxland Regional Cancer Center
- Siouxland Hematology-Oncology Associates
- Mercy Medical Center - Sioux City
- St. Luke's Regional Medical Center
- Medical Oncology and Hematology Associates - West Des Moines
- Cancer Center of Kansas - Chanute
- Cancer Center of Kansas - Dodge City
- Cancer Center of Kansas, P.A. - El Dorado
- Cancer Center of Kansas - Kingman
- Southwest Medical Center
- Cancer Center of Kansas - Newton
- Cancer Center of Kansas, P.A. - Parsons
- Pratt Cancer Center of Kansas
- Cancer Center of Kansas - Salina
- Cancer Center of Kansas - Wellington
- Associates in Womens Health
- Cancer Center of Kansas, P.A.
- Cancer Center of Kansas, P.A. - Wichita
- CCOP - Wichita
- Via Christi Cancer Center at Via Christi Regional Medical Center
- Cancer Center of Kansas - Winfield
- Hickman Cancer Center at Bixby Medical Center
- Green Bay Oncology, Limited - Escanaba
- Green Bay Oncology, Limited - Iron Mountain
- Haematology-Oncology Associates of Ohio and Michigan, P.C.
- Community Cancer Center of Monroe
- Mercy Memorial Hospital System
- MeritCare Clinic - Bemidji
- Brainerd Medical Center
- St. Joseph's Medical Center
- Fairview Ridges Hospital
- Mercy and Unity Cancer Center at Mercy Hospital
- CCOP - Duluth
- Miller-Dwan Medical Center
- St. Mary's - Duluth Clinic Cancer Center
- Fairview Southdale Hospital
- Mercy and Unity Cancer Center at Unity Hospital
- Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
- Chippewa County - Montevideo Hospital
- Hubert H. Humphrey Cancer Center at North Memorial Medical Center
- Mayo Clinic Cancer Center
- St. Cloud Hospital
- CCOP - Metro-Minnesota
- Adult and Pediatric Urology, P.L.L.P.
- CentraCare Clinic - River Campus
- Park Nicollet Health Services
- United Hospital
- Ridgeview Medical Center
- CCOP - Montana Cancer Consortium
- Deaconess Billings Clinic - Downtown
- Northern Rockies Radiation Oncology Center
- St. Vincent Healthcare
- Deaconess Billings Clinic Cancer Center
- Bozeman Deaconess Hospital
- St. James Community Hospital
- Great Falls Clinic
- Sletten Regional Cancer Institute
- St. Peter's Hospital
- Kalispell Regional Medical Center
- Eastern Montana Cancer Center
- Community Medical Center
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
- Fremont Area Medical Center
- CCOP - Missouri Valley Cancer Consortium
- Immanuel Medical Center
- Bergan Mercy Medical Center
- Creighton University Medical Center
- Midlands Cancer Center at Midlands Community Hospital
- Rutherford Hospital
- Bismarck Cancer Center
- Cancer Care Center at Medcenter One Hospital
- Mid Dakota Clinic, P.C.
- St. Alexius Medical Center
- CCOP - MeritCare Hospital
- MeritCare Medical Group
- Wood County Oncology Center
- Grandview Hospital
- Good Samaritan Hospital
- David L. Rike Cancer Center at Miami Valley Hospital
- Samaritan North Cancer Care Center
- Veterans Affairs Medical Center - Dayton
- CCOP - Dayton
- Blanchard Valley Medical Associates
- Fremont Memorial Hospital
- Kenton Oncology, Incorporated
- Charles F. Kettering Memorial Hospital
- Lima Memorial Hospital
- Northwest Ohio Oncology Center
- St. Luke's Hospital
- Middletown Regional Hospital
- St. Charles Mercy Hospital
- Toledo Clinic - Oregon
- Firelands Regional Medical Center
- North Coast Cancer Care, Incorporated
- Promedica Cancer Center at Flower Hospital
- Mercy Hospital of Tiffin
- Toledo Hospital
- St. Vincent Mercy Medical Center
- Medical College of Ohio Cancer Institute
- CCOP - Toledo Community Hospital
- Toledo Clinic, Incorporated
- Toledo Surgical Specialists
- UVMC Cancer Care Center at Upper Valley Medical Center
- Fulton County Health Center
- United States Air Force Medical Center Wright-Patterson
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
- Natalie Warren Bryant Cancer Center at St. Francis Hospital
- Geisinger Medical Center
- Geisinger Medical Group
- Geisinger Wyoming Valley Medical Center
- Rose Ramer Cancer Clinic at Anderson Area Medical Center
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
- CCOP - Upstate Carolina
- Sioux Valley Hospital and University of South Dakota Medical Center
- Avera McKennan Hospital and University Health Center
- Medical X-Ray Center
- Luther Mildelfort Hospital
- Midelfort Clinic - Luther
- Green Bay Oncology, Limited at St. Vincent Hospital
- St. Vincent Hospital
- Green Bay Oncology, Limited at St. Mary's Hospital
- St. Mary's Hospital Medical Center
- Franciscan Skemp Healthcare
- Green Bay Oncology, Limited - Oconto Falls
- Green Bay Oncology, Limited - Sturgeon Bay
- Welch Cancer Center
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
infliximab + docetaxel
placebo + 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.
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.