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)

Sponsor
Alliance for Clinical Trials in Oncology (Other)
Overall Status
Completed
CT.gov ID
NCT00040885
Collaborator
National Cancer Institute (NCI) (NIH)
67
188
2
72
0.4
0

Study Details

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)

Condition or Disease Intervention/Treatment Phase
Phase 3

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
67 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Supportive Care
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 Start Date :
Oct 1, 2002
Actual Primary Completion Date :
Feb 1, 2006
Actual Study Completion Date :
Oct 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Biological: infliximab

Drug: docetaxel

Active Comparator: 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.

Drug: docetaxel

Other: placebo

Outcome Measures

Primary Outcome Measures

  1. Assessment of weight [Up to 5 years]

  2. Rate of weight change [Up to 5 years]

Secondary Outcome Measures

  1. Overall survival [Up to 5 years]

  2. Incidence of treatment-related toxicity [Up to 5 years]

  3. Cancer-related fatigue as measured by the Brief Fatigue Inventory [Up to 5 years]

  4. Time-to-weight decline [Up to 5 years]

  5. Appetite [Up to 5 years]

  6. Lean tissue changes [Up to 5 years]

  7. Quality of life [Up to 5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CCOP - Mayo Clinic Scottsdale Oncology Program Scottsdale Arizona United States 85259
2 Aurora Presbyterian Hospital Aurora Colorado United States 80012
3 Boulder Community Hospital Boulder Colorado United States 80301
4 Penrose Cancer Center at Penrose Hospital Colorado Springs Colorado United States 80933
5 Porter Adventist Hospital Denver Colorado United States 80210
6 Presbyterian - St. Luke's Medical Center Denver Colorado United States 80218
7 St. Joseph Hospital Denver Colorado United States 80218
8 Rose Medical Center Denver Colorado United States 80220
9 CCOP - Colorado Cancer Research Program, Incorporated Denver Colorado United States 80224-2522
10 Swedish Medical Center Englewood Colorado United States 80110
11 Sky Ridge Medical Center Lone Tree Colorado United States 80124
12 Hope Cancer Care Center at Longmont United Hospital Longmont Colorado United States 80502
13 St. Mary-Corwin Regional Medical Center Pueblo Colorado United States 81004
14 North Suburban Medical Center Thorton Colorado United States 80229
15 Mayo Clinic - Jacksonville Jacksonville Florida United States 32224-9980
16 Rush-Copley Cancer Care Center Aurora Illinois United States 60507
17 St. Joseph Medical Center Bloomington Illinois United States 61701
18 Graham Hospital Canton Illinois United States 61520
19 Memorial Hospital Carthage Illinois United States 62321
20 Eureka Community Hospital Eureka Illinois United States 61530
21 Galesburg Clinic Galesburg Illinois United States 61401
22 Galesburg Cottage Hospital Galesburg Illinois United States 61401
23 InterCommunity Cancer Center of Western Illinois Galesburg Illinois United States 61401
24 Mason District Hospital Havana Illinois United States 62644
25 Hopedale Medical Complex Hopedale Illinois United States 61747
26 Joliet Oncology Hematology Associates, Limited - West Joliet Illinois United States 60435
27 Kewanee Hospital Kewanee Illinois United States 61443
28 McDonough District Hospital Macomb Illinois United States 61455
29 BroMenn Regional Medical Center Normal Illinois United States 61761
30 Community Cancer Center Normal Illinois United States 61761
31 Community Hospital of Ottawa Ottawa Illinois United States 61350
32 Oncology Hematology Associates of Central Illinois - Ottawa Ottawa Illinois United States 61350
33 Cancer Treatment Center at Pekin Hospital Pekin Illinois United States 61554
34 Methodist Medical Center of Illinois Peoria Illinois United States 61603
35 Proctor Hospital Peoria Illinois United States 61614
36 CCOP - Illinois Oncology Research Association Peoria Illinois United States 61615
37 Oncology/Hematology Associates of Central Illinois, P.C. Peoria Illinois United States 61615
38 OSF St. Francis Medical Center Peoria Illinois United States 61637
39 Illinois Valley Community Hospital Peru Illinois United States 61354
40 Perry Memorial Hospital Princeton Illinois United States 61356
41 St. Margaret's Hospital Spring Valley Illinois United States 61362
42 Valley Cancer Center Spring Valley Illinois United States 61362
43 Carle Cancer Center at Carle Foundation Hospital Urbana Illinois United States 61801
44 CCOP - Carle Cancer Center Urbana Illinois United States 61801
45 St. Francis Hospital and Health Centers Beech Grove Indiana United States 46107
46 Saint Anthony Memorial Health Centers Michigan City Indiana United States 46360
47 Saint Anthony Regional Hospital Carroll Iowa United States 51401
48 St. Luke's Hospital Cedar Rapids Iowa United States 52402
49 Cedar Rapids Oncology Associates Cedar Rapids Iowa United States 52403
50 Mercy Cancer Center at Mercy Medical Center Cedar Rapids Iowa United States 52403
51 Alegent Health Mercy Hospital Council Bluffs Iowa United States 51503
52 Mercy Capitol Hospital Des Moines Iowa United States 50307
53 CCOP - Iowa Oncology Research Association Des Moines Iowa United States 50309
54 John Stoddard Cancer Center at Iowa Methodist Medical Center Des Moines Iowa United States 50309
55 Medical Oncology and Hematology Associates at John Stoddard Cancer Center Des Moines Iowa United States 50309
56 Medical Oncology and Hematology Associates at Mercy Cancer Center Des Moines Iowa United States 50314
57 Mercy Cancer Center at Mercy Medical Center - Des Moines Des Moines Iowa United States 50314
58 John Stoddard Cancer Center at Iowa Lutheran Hospital Des Moines Iowa United States 50316
59 Mercy Cancer Center at Mercy Medical Center - North Iowa Mason City Iowa United States 50401
60 Alegent Health Community Memorial Hospital Missouri Valley Iowa United States 51555
61 Burgess Health Center Onawa Iowa United States 51040
62 Ottumwa Regional Health Center Cancer Center Ottumwa Iowa United States 52501
63 Siouxland Regional Cancer Center Sioux City Iowa United States 51101-1733
64 Siouxland Hematology-Oncology Associates Sioux City Iowa United States 51101
65 Mercy Medical Center - Sioux City Sioux City Iowa United States 51104
66 St. Luke's Regional Medical Center Sioux City Iowa United States 51104
67 Medical Oncology and Hematology Associates - West Des Moines West Des Moines Iowa United States 50266
68 Cancer Center of Kansas - Chanute Chanute Kansas United States 66720
69 Cancer Center of Kansas - Dodge City Dodge City Kansas United States 67801
70 Cancer Center of Kansas, P.A. - El Dorado El Dorado Kansas United States 67042
71 Cancer Center of Kansas - Kingman Kingman Kansas United States 67068
72 Southwest Medical Center Liberal Kansas United States 67901
73 Cancer Center of Kansas - Newton Newton Kansas United States 67114
74 Cancer Center of Kansas, P.A. - Parsons Parsons Kansas United States 67357
75 Pratt Cancer Center of Kansas Pratt Kansas United States 67124
76 Cancer Center of Kansas - Salina Salina Kansas United States 67042
77 Cancer Center of Kansas - Wellington Wellington Kansas United States 67152
78 Associates in Womens Health Wichita Kansas United States 67203
79 Cancer Center of Kansas, P.A. Wichita Kansas United States 67208
80 Cancer Center of Kansas, P.A. - Wichita Wichita Kansas United States 67214
81 CCOP - Wichita Wichita Kansas United States 67214
82 Via Christi Cancer Center at Via Christi Regional Medical Center Wichita Kansas United States 67214
83 Cancer Center of Kansas - Winfield Winfield Kansas United States 67156
84 Hickman Cancer Center at Bixby Medical Center Adrian Michigan United States 49221
85 Green Bay Oncology, Limited - Escanaba Escanaba Michigan United States 49431
86 Green Bay Oncology, Limited - Iron Mountain Iron Mountain Michigan United States 49801
87 Haematology-Oncology Associates of Ohio and Michigan, P.C. Lambertville Michigan United States 48144
88 Community Cancer Center of Monroe Monroe Michigan United States 48162
89 Mercy Memorial Hospital System Monroe Michigan United States 48162
90 MeritCare Clinic - Bemidji Bemidji Minnesota United States 56601
91 Brainerd Medical Center Brainerd Minnesota United States 56401
92 St. Joseph's Medical Center Brainerd Minnesota United States 56401
93 Fairview Ridges Hospital Burnsville Minnesota United States 55337
94 Mercy and Unity Cancer Center at Mercy Hospital Coon Rapids Minnesota United States 55433
95 CCOP - Duluth Duluth Minnesota United States 55805
96 Miller-Dwan Medical Center Duluth Minnesota United States 55805
97 St. Mary's - Duluth Clinic Cancer Center Duluth Minnesota United States 55805
98 Fairview Southdale Hospital Edina Minnesota United States 55435
99 Mercy and Unity Cancer Center at Unity Hospital Fridley Minnesota United States 55432
100 Virginia Piper Cancer Institute at Abbott-Northwestern Hospital Minneapolis Minnesota United States 55403
101 Chippewa County - Montevideo Hospital Montevideo Minnesota United States 56265
102 Hubert H. Humphrey Cancer Center at North Memorial Medical Center Robbinsdale Minnesota United States 55422
103 Mayo Clinic Cancer Center Rochester Minnesota United States 55905
104 St. Cloud Hospital Saint Cloud Minnesota United States 56303
105 CCOP - Metro-Minnesota Saint Louis Park Minnesota United States 55416
106 Adult and Pediatric Urology, P.L.L.P. St. Cloud Minnesota United States 56303
107 CentraCare Clinic - River Campus St. Cloud Minnesota United States 56303
108 Park Nicollet Health Services St. Louis Park Minnesota United States 55416
109 United Hospital St. Paul Minnesota United States 55102
110 Ridgeview Medical Center Waconia Minnesota United States 55387
111 CCOP - Montana Cancer Consortium Billings Montana United States 59101
112 Deaconess Billings Clinic - Downtown Billings Montana United States 59101
113 Northern Rockies Radiation Oncology Center Billings Montana United States 59101
114 St. Vincent Healthcare Billings Montana United States 59101
115 Deaconess Billings Clinic Cancer Center Billings Montana United States 59107
116 Bozeman Deaconess Hospital Bozeman Montana United States 59715
117 St. James Community Hospital Butte Montana United States 59701
118 Great Falls Clinic Great Falls Montana United States 59405
119 Sletten Regional Cancer Institute Great Falls Montana United States 59405
120 St. Peter's Hospital Helena Montana United States 59601
121 Kalispell Regional Medical Center Kalispell Montana United States 59901
122 Eastern Montana Cancer Center Miles City Montana United States 59301
123 Community Medical Center Missoula Montana United States 59801
124 Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Missoula Montana United States 59802
125 Fremont Area Medical Center Fremont Nebraska United States 68025
126 CCOP - Missouri Valley Cancer Consortium Omaha Nebraska United States 68106
127 Immanuel Medical Center Omaha Nebraska United States 68122
128 Bergan Mercy Medical Center Omaha Nebraska United States 68124
129 Creighton University Medical Center Omaha Nebraska United States 68131
130 Midlands Cancer Center at Midlands Community Hospital Papillion Nebraska United States 68046
131 Rutherford Hospital Rutherfordton North Carolina United States 28139
132 Bismarck Cancer Center Bismarck North Dakota United States 58501
133 Cancer Care Center at Medcenter One Hospital Bismarck North Dakota United States 58501
134 Mid Dakota Clinic, P.C. Bismarck North Dakota United States 58501
135 St. Alexius Medical Center Bismarck North Dakota United States 58501
136 CCOP - MeritCare Hospital Fargo North Dakota United States 58122
137 MeritCare Medical Group Fargo North Dakota United States 58122
138 Wood County Oncology Center Bowling Green Ohio United States 43402
139 Grandview Hospital Dayton Ohio United States 45405
140 Good Samaritan Hospital Dayton Ohio United States 45406
141 David L. Rike Cancer Center at Miami Valley Hospital Dayton Ohio United States 45409
142 Samaritan North Cancer Care Center Dayton Ohio United States 45415
143 Veterans Affairs Medical Center - Dayton Dayton Ohio United States 45428
144 CCOP - Dayton Dayton Ohio United States 45429
145 Blanchard Valley Medical Associates Findlay Ohio United States 45840
146 Fremont Memorial Hospital Fremont Ohio United States 43420
147 Kenton Oncology, Incorporated Kenton Ohio United States 43326
148 Charles F. Kettering Memorial Hospital Kettering Ohio United States 45429
149 Lima Memorial Hospital Lima Ohio United States 45804
150 Northwest Ohio Oncology Center Maumee Ohio United States 43537
151 St. Luke's Hospital Maumee Ohio United States 43537
152 Middletown Regional Hospital Middletown Ohio United States 45044
153 St. Charles Mercy Hospital Oregon Ohio United States 43616
154 Toledo Clinic - Oregon Oregon Ohio United States 43616
155 Firelands Regional Medical Center Sandusky Ohio United States 44870
156 North Coast Cancer Care, Incorporated Sandusky Ohio United States 44870
157 Promedica Cancer Center at Flower Hospital Sylvania Ohio United States 43560
158 Mercy Hospital of Tiffin Tiffin Ohio United States 44883
159 Toledo Hospital Toledo Ohio United States 43606
160 St. Vincent Mercy Medical Center Toledo Ohio United States 43608
161 Medical College of Ohio Cancer Institute Toledo Ohio United States 43614
162 CCOP - Toledo Community Hospital Toledo Ohio United States 43623
163 Toledo Clinic, Incorporated Toledo Ohio United States 43623
164 Toledo Surgical Specialists Toledo Ohio United States 43623
165 UVMC Cancer Care Center at Upper Valley Medical Center Troy Ohio United States 45373
166 Fulton County Health Center Wauseon Ohio United States 43567
167 United States Air Force Medical Center Wright-Patterson Wright-Patterson Afb Ohio United States 45433-5529
168 Ruth G. McMillan Cancer Center at Greene Memorial Hospital Xenia Ohio United States 45385
169 Natalie Warren Bryant Cancer Center at St. Francis Hospital Tulsa Oklahoma United States 74136
170 Geisinger Medical Center Danville Pennsylvania United States 17822-2001
171 Geisinger Medical Group State College Pennsylvania United States 16801
172 Geisinger Wyoming Valley Medical Center Wilkes-Barre Pennsylvania United States 18711
173 Rose Ramer Cancer Clinic at Anderson Area Medical Center Anderson South Carolina United States 29621
174 Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Spartanburg South Carolina United States 29303
175 CCOP - Upstate Carolina Spartanburg South Carolina United States 29304
176 Sioux Valley Hospital and University of South Dakota Medical Center Sioux Falls South Dakota United States 57104
177 Avera McKennan Hospital and University Health Center Sioux Falls South Dakota United States 57105
178 Medical X-Ray Center Sioux Falls South Dakota United States 57105
179 Luther Mildelfort Hospital Eau Claire Wisconsin United States 54702
180 Midelfort Clinic - Luther Eau Claire Wisconsin United States 54702
181 Green Bay Oncology, Limited at St. Vincent Hospital Green Bay Wisconsin United States 54301-3526
182 St. Vincent Hospital Green Bay Wisconsin United States 54301
183 Green Bay Oncology, Limited at St. Mary's Hospital Green Bay Wisconsin United States 54303
184 St. Mary's Hospital Medical Center Green Bay Wisconsin United States 54303
185 Franciscan Skemp Healthcare La Crosse Wisconsin United States 54601
186 Green Bay Oncology, Limited - Oconto Falls Oconto Falls Wisconsin United States 54154
187 Green Bay Oncology, Limited - Sturgeon Bay Sturgeon Bay Wisconsin United States 54235
188 Welch Cancer Center Sheridan Wyoming United States 82801

Sponsors and Collaborators

  • Alliance for Clinical Trials in Oncology
  • National Cancer Institute (NCI)

Investigators

  • Study Chair: Aminah Jatoi, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00040885
Other Study ID Numbers:
  • NCCTG-N01C9
  • NCI-2012-02472
  • NCI-P02-0226
  • CDR0000069417
First Posted:
Jan 27, 2003
Last Update Posted:
Dec 7, 2016
Last Verified:
Dec 1, 2016

Study Results

No Results Posted as of Dec 7, 2016